On behalf of the Swedish Ministry for Foreign Affairs and Gavi, the Global Vaccine Alliance, NorthX Biologics’ CEO Janet Hoogstraate participated in an important roundtable on “Leveraging Technology and Innovation to Ensure Every Child is Vaccinated” on December 10, 2024.Joined by other Swedish companies and international organisations with experiences in pioneering innovations in technology and sustainability, together they explored how to contribute to reaching the 14.5 million children in the world who still lack vaccines.
Read Janet’s statement below.
Your excellencies, Ladies and Gentlemen,
It is an honor to join this important conversation about leveraging technology and innovation to ensure every child is vaccinated. At NorthX Biologics, we are deeply committed to driving change and contributing meaningfully to this global effort.
First, scaling up vaccine manufacturing processes is at the heart of what we do. By leveraging cutting-edge technologies and robust expertise, NorthX Biologics is well-positioned to increase production capacity for both new and existing vaccines. This ensures rapid response to global health needs.
Second, we believe in the power of technology transfer to low- and middle-income countries. Establishing local manufacturing hubs is crucial for self-sufficiency and long-term vaccine security. We are ready to collaborate with partners to transfer our expertise and support the creation of regional production capabilities. We are proud of our history of working on scaling up and manufacturing of clinical trial material for a more affordable polio vaccine, having been part of two projects supported by the Bill & Melinda Gates Foundation.
Third, capacity building is essential. At NorthX Biologics, we prioritize training staff in Good Manufacturing Practices (GMP), biotechnology, and advanced analytical techniques. By equipping local teams with the skills they need, we help build sustainable ecosystems for vaccine development and production.
Fourth, we recognize the urgent need for cost-effective solutions. By working to redesign and redevelop vaccines—for instance, making them more stable so they can be transported at room temperature rather than refrigerated—we can make vaccines more accessible and reduce logistical challenges. We are currently a partner in an oral cholera vaccine project collaborating with professor Jan Holmgren and the International Vaccine Institute. These partnerships demonstrate our commitment to advancing vaccine access and global health equity.
Finally, our capabilities extend to manufacturing new vaccines and quality control analyses to ensure their safety, quality and consistency.
NorthX Biologics is not just a manufacturer; we are a partner in innovation, committed to finding creative solutions to global challenges. By collaborating with governments, non-profits, companies and other stakeholders, we can collectively work towards a future where no child is left behind in receiving life-saving vaccines.
I look forward to exploring new approaches and opportunities for collaboration with all of you. Together, we can ensure a healthier, brighter future for every child.
Based on a presentation given by Thomas Eldered at the PharmaOutsourcing event, Stockholm Sweden, December 2024.
From vertical integration to decentralization
The pharmaceutical industry has undergone a seismic shift over the last several decades, transitioning from a vertically integrated model to a decentralized ecosystem of partnerships and specialized services. This transformation has ushered in what many now recognize as the CDMO era—an age defined by outsourcing, collaboration, and rapid innovation. For investors, this evolution presents a unique opportunity to engage with a sector that is both resilient and dynamic.
Historically, pharmaceutical companies operated under a fully integrated model, where they controlled every aspect of drug discovery, development, and manufacturing. This model dominated for much of the 20th century, providing developers with full control over their intellectual property, supply chains, and manufacturing processes. However, as the complexity of drug development grew, the limitations of this approach became apparent. The cost of maintaining in-house expertise for increasingly specialized tasks, coupled with the inefficiencies inherent in such a broad operational scope, began to erode the model’s viability.
The late 1990s and early 2000s marked a pivotal turning point. Advances in biotechnology during this period brought about the “biotech revolution”, shifting the industry’s focus toward complex biologics, including monoclonal antibodies, cell therapies, and gene therapies. These modalities required specialized knowledge and infrastructure that many pharmaceutical companies lacked. Simultaneously, the competitive pressure to reduce time-to-market and development costs became more pronounced. These factors paved the way for the rise of Contract Development and Manufacturing Organizations (CDMOs).
The 2000s saw the rapid proliferation of CDMOs, with companies like Covance, Charles River, and Recipharm emerging as major players in the field. These organizations offered a compelling value proposition: they provided access to specialized expertise and state-of-the-art facilities, enabling pharmaceutical firms to focus on core competencies like research and commercialization. By outsourcing development and manufacturing tasks, companies could reduce their risk in operating manufacturing facilities running half empty, and thereby reduce their capital expenditures, manage risks more effectively, and accelerate product development timelines.
A new era in pharmaceutical development
This shift toward outsourcing marked the beginning of a new era in pharmaceutical development. The model of the “virtual organization” emerged, where biotech startups and even mid-sized firms operated with minimal in-house teams, relying instead on an extensive network of external partners. This approach proved particularly well-suited for early-stage companies, which often faced resource constraints but needed to navigate complex regulatory and technical challenges.
By 2010, the CDMO sector had become an integral part of the life sciences ecosystem. The global CDMO market was expanding rapidly, driven by several key factors. First, the demand for biologics and personalized medicine continued to grow, requiring specialized manufacturing capabilities. Second, the industry faced increasing regulatory scrutiny, necessitating advanced analytical and compliance expertise. Third, the globalization of pharmaceutical supply chains highlighted the need for flexible and scalable manufacturing solutions.
Today, the CDMO industry is a cornerstone of pharmaceutical innovation. The market is characterized by a high degree of specialization, with firms offering tailored solutions across various modalities, including small molecules, biologics, and advanced therapies. This specialization is complemented by a trend toward consolidation, as larger CDMOs acquire smaller, niche players to enhance their capabilities and geographic reach.
In the late 1990s, Thomas Eldered experienced a pivotal moment during a board meeting at a mid-sized pharmaceutical company. The team, juggling the dual challenges of R&D and manufacturing, faced mounting pressure to deliver a promising biologic. One executive’s comment, “We’re scientists, not manufacturers,” struck a chord with Thomas, highlighting the industry’s struggle to manage increasingly complex tasks in-house.
This realization mirrored broader challenges across the pharmaceutical sector. Over the following years, Thomas saw how outsourcing to specialized CDMOs became a game-changer. These partnerships allowed biotech companies to focus on innovation while tapping into the advanced infrastructure and expertise of their collaborators.
In the early 2000s, Thomas witnessed the success of this model firsthand when a small biotech client outsourced its manufacturing to a budding CDMO. The move halved development timelines and helped the company navigate regulatory hurdles, showcasing the real potential of these partnerships.
Today, CDMOs are seen as a cornerstone of the pharmaceutical ecosystem. In areas like cell and gene therapy, outsourcing has become essential for staying agile and precise, reflecting the industry’s shift from working in isolation to embracing collaboration.
NorthX Biologics: beyond traditional CDMO services
Within this competitive landscape, NorthX Biologics has emerged as a unique and innovative player. Unlike many of its peers, NorthX Biologics positions itself not just as a traditional CDMO but as an “Beyond CDMO” operating an Innovation Hub offering a range of services designed to support the development and manufacturing of advanced therapies. The company history reflects its deep roots in pharmaceutical manufacturing. Established as the Swedish National Center for Disease Control in 1909, the organization evolved over decades, eventually transitioning into NorthX Biologics in 2021.
NorthX Biologics’ service offering is comprehensive, encompassing microbial and mammalian expression systems, plasmid DNA, recombinant proteins, viral vectors, and cell therapy solutions. These capabilities are underpinned by a robust infrastructure that includes state-of-the-art GMP facilities, advanced analytical laboratories, and flexible cleanrooms. Notably, a proven track record of regulatory compliance, with multiple successful inspections by the Swedish Medical Products Agency.
One of NorthX Biologics distinguishing features is its focus on advanced therapies, such as cell and gene therapies, mRNA technologies, and personalized medicines. For example, the company has played a critical role in several high-profile projects, including the rapid development of clinical trial materials for novel immunotherapies. In one notable case, NorthX supported HOOKIPA Pharma in scaling up the manufacturing process for a viral vector product, enabling the company to meet tight clinical trial timelines. This project, completed within 18 months, exemplifies NorthX’s ability to deliver innovative solutions under challenging conditions.
Another hallmark is its emphasis on collaboration. The company works closely with clients to understand their unique needs, leveraging its expertise to develop tailored solutions. This collaborative ethos is evident in its work with Mendus, a clinical-stage immuno-oncology company. Together, they established a scalable manufacturing process for Mendus’ lead cell-based therapy, overcoming significant technical and logistical challenges.
When compared to industry giants like Lonza and Catalent, NorthX Biologics differentiation lies in its agility and focus on emerging modalities. While larger CDMOs excel at providing broad, end-to-end solutions, the company offers a more specialized and nimble approach. This is particularly valuable for biotech startups and smaller pharmaceutical firms, which often require customized support to navigate the complexities of advanced therapy development.
CDMOS: a de-risked investment opportunity
The investor perspective on the CDMO sector is overwhelmingly positive. CDMOs represent a de-risked investment opportunity, as their business models are inherently diversified. By serving multiple clients across various therapeutic areas, CDMOs can mitigate the risks associated with individual product failures. Additionally, the sector benefits from strong, long-term societal trends, including an aging population, rising healthcare expenditures, and the growing prevalence of chronic diseases.
For investors, companies like NorthX Biologics signal a forward-thinking approach to pharmaceutical development. The combination of advanced capabilities, collaborative ethos, and focus on innovation positions it as a leader in the rapidly evolving CDMO landscape. The company’s emphasis on advanced therapies aligns with the broader industry trend toward personalized medicine, offering significant growth potential in the years ahead.
Continued growth and transformation
Looking to the future, the CDMO industry is poised for continued growth and transformation. One key trend is the increasing integration of digital technologies, such as artificial intelligence and automation, into manufacturing processes. These technologies have the potential to enhance efficiency, reduce costs, and improve product quality. Another trend is the regionalization of manufacturing capabilities, driven by geopolitical considerations and the need to mitigate supply chain risks.
The pharmaceutical industry is also moving toward a more collaborative ecosystem, where partnerships between CDMOs, biotech firms, and academic institutions play a central role in driving innovation. This shift is particularly evident in the advanced therapy space, where the complexity of products necessitates close collaboration between stakeholders.
In conclusion, the rise of the CDMO era represents a profound shift in the pharmaceutical industry. This transformation has been driven by the need for specialization, efficiency, and collaboration, creating new opportunities for innovation and growth. Companies like NorthX Biologics exemplify the potential of this new paradigm, offering tailored solutions that enable clients to navigate the complexities of advanced therapy development. For investors, the CDMO sector offers a compelling opportunity to engage with a dynamic and resilient industry that is shaping the future of healthcare. As the pharmaceutical landscape continues to evolve, the role of CDMOs will only grow in importance, making this an exciting time for both industry stakeholders and investors alike.
With a rich historical legacy and decades of expertise at its two sites, NorthX Biologics has long mastered the complexities of microbial and mammalian manufacturing. By offering capabilities and differentiating experience in both expression systems, NorthX Biologics provides tailored, cost-effective solutions that optimize processes and meet the diverse needs of recombinant protein production.
Authors: Peter Boman, Chief Operations Officer, and Helena Pettersson, Chief Production Officer, Head of USP, NorthX Biologics
Distinct approaches in biomanufacturing: mammalian cell culture vs. microbial fermentation
In biopharmaceutical manufacturing, mammalian cell culture remains a dominant method, commonly utilizing Chinese hamster ovary (CHO) cells for producing protein-based drugs and human embryonic kidney (HEK) cells for viral vectors. However, microbial fermentation, which employs bacteria like Escherichia coli and Pseudomonas fluorescens, as well as yeasts like Saccharomyces cerevisiae and Pichia pastoris, is gaining traction, especially with the rise of new modalities, such as nucleic acids, single-domain antibodies, peptidbodies, and antibody fragments.
One of the main advantages of microbial fermentation is speed. Whereas mammalian cell culture processes can take six weeks or more from start to purified drug substance, fermentation processes are typically completed within a few days. Additionally, mammalian cells require complex and costly media formulations — often containing up to 100 ingredients — while bacteria and yeast need only simple glucose-based feeds. Microbial systems also tend to express target substances at higher concentrations than mammalian cells, further enhancing their appeal for specific applications.
However, bacteria and yeast have limitations. They are generally inefficient at producing larger recombinant proteins and monoclonal antibodies, making them better suited for smaller biologics, such as peptides, cytokines, and growth factors. Furthermore, microbial systems lack the capacity for extensive post-translational modifications (PTMs), such as glycosylation, which restricts their use in applications that require these modifications, including the prevalent monoclonal antibodies. Mammalian cell culture, therefore, is often the preferred option for these more complex requirements, as it provides the capabilities that microbial systems cannot.
The capability to offer both mammalian cell culture and microbial fermentation allows a comprehensive contract development and manufacturing organization (CDMO) like NorthX Biologics to better tailor production processes to the unique needs of each biomolecule. Advances in fermentation technology enable the efficient and cost-effective production of smaller and less complex biologics, while innovations in mammalian cell culture, such as enhanced titers and improved process control, support the manufacture of more complex biomolecules requiring intricate post-translational modifications. By leveraging expertise in both systems, forward-thinking CDMOs can provide optimized, high-quality solutions across a broad range of biologics, ultimately delivering greater value to their clients.
Matching biomolecules to manufacturing systems
Choosing between mammalian cell culture and microbial fermentation for biopharmaceutical production requires a balance of financial, technical, and quality considerations. The optimal manufacturing system for a drug candidate depends primarily on the unique characteristics of the biomolecule, including its size, complexity, and need for PTMs, as well as the intended use of the final product.
For some biomolecules, production in mammalian cells is necessary due to their capacity to perform complex modifications, while other substances are more efficiently produced through microbial fermentation. In certain cases, a highly sensitive protein may benefit from fermentation’s shorter production timeline, which can reduce the risk of degradation. Quality standards also vary across products, with some requiring exceptionally high purity that may be easier to achieve with one system over the other.
Ultimately, understanding these specific requirements early in the development process helps ensure that the chosen manufacturing path is both efficient and cost-effective.
Advances in mammalian bioproduction: higher titers and enhanced control
Mammalian cell culture has seen remarkable advancements over the past two decades, most notably a significant increase in production titers. While titers of 0.1 grams per liter were typical when biologics first entered the market, today’s processes commonly achieve titers of 10 grams per liter or higher. This leap has been driven by a deeper understanding of cellular mechanisms and the adoption of automation and digitalization in biomanufacturing.
Process analytical technologies now enable real-time monitoring and control, providing insights that have propelled improvements in cell-line engineering and media formulation. These innovations allow biopharma companies to better optimize mammalian cell culture processes, enhancing both productivity and efficiency.
Enhancing fermentation efficiency: optimizing strains and streamlining processes
Recent advancements in bacterial and yeast expression systems have focused on increasing efficiency and reducing production costs. New microbial strains now allow for more effective expression across a broader range of proteins, expanding the applicability of fermentation. Additionally, significant improvements in downstream processing have been achieved, as this stage traditionally accounts for a large portion of the cost of goods in biologics manufacturing.
One of the primary goals in downstream optimization has been to minimize the number of costly chromatography steps. Techniques such as heat inactivation and precipitation are now used to simplify protein purification, offering a more cost-effective and efficient approach to removing undesired proteins. These developments make microbial fermentation a more competitive option for producing biologics.
Accelerating bioprocessing with AI-driven efficiency
Optimizing bioprocesses, whether through mammalian cell culture or microbial fermentation, involves extensive and costly screening of cell lines and process parameters. Today, digitalization — particularly through artificial intelligence (AI) and machine learning (ML) — is transforming this process by enabling biopharmaceutical scientists to work more efficiently and effectively.
With adequate data, AI and ML algorithms can streamline the design of complex studies, such as design-of-experiment (DoE) frameworks, helping researchers reduce preparation time and gain richer, more actionable insights. These digital tools allow for smarter process development, accelerating the pathway to optimized production for both traditional and emerging biomanufacturing systems.
Trusted expertise in mammalian expression at NorthX Biologics
Although formally established in 2021, NorthX Biologics draws on decades of biological manufacturing expertise, emerging from a combination of legacy entities. The company’s mammalian cell culture capabilities expanded significantly with the acquisition of a specialized development and manufacturing facility from Valneva in Stockholm, Sweden, bringing a team of experts in mammalian process development, GMP manufacturing, and state-of-the-art equipment.
NorthX’s clients benefit from close collaboration with scientists who bring deep process knowledge from development through to commercial production. With extensive experience in process development and scale-up, the team at NorthX Biologics ensures that manufacturability is built into each project from the start, helping clients avoid potential challenges during GMP implementation.
Furthermore, NorthX Biologics is well equipped to support comparability studies for products transitioning from early to late-stage clinical trials, ensuring continuity and consistency. Transparency and open communication are foundational to NorthX’s approach, fostering trust both within the team and with clients. NorthX’s clients know they can rely on the company for timely, complete, and quality-driven delivery.
Microbial fermentation expertise at NorthX Biologics
NorthX Biologics’ Matfors, Sweden site has been manufacturing proteins through microbial fermentation since the early 1990s. While the site has a long history in biologics production, it transitioned to a multiproduct contract manufacturing organization in 2005 and has since undergone continuous investment to expand its capabilities. These include fill/finish services, high-quality plasmid manufacturing, enhanced quality control capabilities, and large-scale protein purification with single-use fermentation suites.
The facility supports a wide range of bacterial fermentation using both anaerobic and aerobic strains and is equipped to handle risk group Level 1 and 2 organisms in Matfors, as well as up to risk group Level 3 organisms at the Stockholm biosafety facility. With extensive in-house analytical and quality assurance capabilities, including QA/QP services and analytical development expertise, NorthX Biologics ensures rigorous oversight across all production stages.
Different strains present unique challenges—some produce lower yields due to limited growth density, while others, like cholera strains, can complicate product purification. With decades of experience as a service provider, NorthX’s team excels at addressing these complexities. They are adept at identifying the ideal strain for each project and tailoring fermentation and lysis methods to achieve optimal results.
NorthX’s facility is designed to accommodate both small-volume production for early-phase studies and large-scale manufacturing for late-stage trials. In high-demand situations, the team is capable of operating on a 24/7 schedule to meet client needs. Supported by experienced project managers with deep expertise in multiproduct facility operations, NorthX Biologics ensures seamless execution across diverse biomanufacturing demands.
Who benefits from partnering with NorthX Biologics?
At NorthX Biologics, our commitment goes beyond being a trustworthy CDMO; we strive to be a true partner in innovation, sustainability, and excellence. Our Innovation Hub in Matfors showcases our dedication to advancing cutting-edge technologies that not only benefit our customers but ultimately improve outcomes for patients worldwide. With a problem-solving mindset and customer-first approach, we support clients at every stage of their journey — from grant writing to navigating the complexities of biologics manufacturing.
NorthX Biologics offers a unique value proposition as a multipurpose, one-stop-shop CDMO. We combine our dual expertise in mammalian and microbial manufacturing with extensive in-house capabilities in analytical development, quality assurance, and large-scale production. This comprehensive service portfolio allows us to streamline drug development and manufacturing, enabling faster, more efficient, and cost-effective solutions for pharmaceutical and biotech companies.
Sustainability is deeply embedded in our operations. We actively collaborate with dedicated sustainability personnel and adhere to guidelines from Swedish authorities to become an increasingly eco-friendly organization. Powered by green electricity and sustainable practices, we are working toward reducing our environmental footprint while maintaining the highest levels of quality and compliance.
Sweden’s reputation for excellence extends to our highly educated workforce, whose expertise ensures the delivery of superior results. Clients benefit from our commitment to delivering products on time, in full, and with exceptional quality. This dedication applies whether you are a small or medium-sized drug developer working on complex, niche, high-value therapeutic candidates or a large biopharma company seeking a reliable CDMO partner for scalable production.
Choosing NorthX Biologics means choosing an experienced, innovative, and sustainable partner that is ready to meet your needs at every stage, from early development to commercialization. With Swedish precision and a proven track record, we deliver high-value solutions that inspire confidence and enable success.
Peter Boman Chief Operations Officer NorthX Biologics
Peter is the COO at NorthX Biologics, and as such responsible for our manufacturing facilities in Matfors. He holds a master’s degree in engineering, biotechnology, and business administration. Peter has worked in research and development with complex sample analytics, analytical development, and cell culture process development. He joined NorthX in 2013 and has since continuously improved his talented team, resulting in the production of a large number of biological drugs for clinical trials.
Helena Pettersson Chief Production Officer, Head of USP NorthX Biologics
Helena is CPO at NorthX Biologics as well as Head of Upstream at our Stockholm site. She holds a master’s degree in chemical engineering, biotechnology from Mälardalens University. With former roles as scientist in process development at Pharmacia, CMC development at SOBI, and leadership in process development at Crucell, Helena brings more than 25 years of experience. She manages a highly skilled and experienced team, making sure we are on top of the advanced therapeutics sector.
NorthX Biologics is at the forefront of technical and therapeutic protein development, playing a critical role in supporting the production of advanced therapies. With over three decades of expertise, NorthX provides scalable solutions from early-stage research to full-scale commercial production, driving innovation in the biopharmaceutical industry.
In our latest article, Eva-karin Gidlund, Ph.D., MBA, Chief Business Officer, explores:
NorthX’s expertise in both technical and therapeutic protein manufacturing
Our scalable production capabilities, from concept to commercialization
The company’s commitment to sustainability and eco-friendly operations in Sweden
Our cutting-edge Innovation Hub as a center for collaborative development
Ready to explore the future of protein production? Download the full article to learn how NorthX Biologics can help advance your biopharma projects.
Driving innovation with scalable protein expertise for advanced therapies
The life sciences and healthcare ecosystem relies on a diverse range of chemical modalities, with technical proteins playing a critical role in enabling the production and purification of therapeutic proteins and advanced therapies. As cell and gene therapies (CGTs) continue to gain momentum, the demand for both technical and therapeutic proteins is set to surge. Backed by three decades of expertise in protein development, flexible manufacturing capabilities, and a commitment to innovation and quality, NorthX Biologics is positioned as a key global partner for biopharma companies. With scalable solutions that support products from early development to commercialization, NorthX Biologics is at the forefront of this rapidly evolving industry.
Harnessing technical proteins to drive the next generation of therapies
The demand for a wide array of modalities within the life science and healthcare ecosystem remains strong, and technical proteins are at the forefront, facilitating the production and purification of therapeutic proteins and playing pivotal roles in the development and manufacturing of advanced therapies. Technical proteins, which are specialized proteins used in the production, purification, or testing of therapeutic proteins and other biological products, are evolving rapidly, with innovative features like bispecific binding and tailored affinity properties driving growth in diagnostic applications. Additionally, as the need for biosafety measures increases, there is growing interest in proteins that can endure rigorous sanitation protocols while retaining their functional capacity over multiple cycles, ensuring the cost-efficiency of therapeutic manufacturing.
Building on a legacy of expertise
NorthX Biologics was established in late 2021, bringing together multiple entities with rich operational histories dating back to 1963, initially having focused on small molecule pharmaceutical manufacturing but expanded into biological manufacturing in the 1990s, specializing in proteins. This deep-rooted experience from sites and teams from these predecessor companies now supports the production of proteins, RNA, cell therapies, virus vaccines, and viral gene delivery systems. NorthX Biologics serves as a key partner for biotechs requiring expert support in these areas. The blend of heritage, Nordic friendliness, continuous innovation, and cutting-edge capabilities defines NorthX’s culture and expertise.
Today, NorthX Biologics supports the North’s global life science industry, offering process and analytical development, analytical testing, and manufacturing services for recombinant proteins used in both therapeutic applications and advanced non-clinical technical purposes. Operating from two sites in Sweden, NorthX Biologics leverages its core competencies in mammalian and microbial production, allowing for efficient, high-quality biotherapeutic protein manufacturing. NorthX supports clients across the entire development spectrum, from early-stage research to full-scale commercial production with scalable production capabilities.
Looking ahead, NorthX Biologics aims to drive further innovation and growth by leveraging its extensive expertise in diverse technical proteins, which positions the company to lead the evolution of biotherapeutics as new formats — such as bispecifics, enzymes, and other complex proteins — become more prominent alongside traditional monoclonal antibodies. The company is preparing for rising demand, particularly for complex proteins involved in advanced and personalized therapies. To meet these evolving needs, NorthX is investing in new technologies and expanding its capacities, ensuring that tailored solutions are delivered to an increasingly diverse customer base.
Scaling success through the innovation hub
NorthX Biologics employs an open and flexible manufacturing model, guiding clients from initial development and market introduction through to scale-up and full commercial production. By capitalizing on an established infrastructure and a robust quality management system, NorthX is able to collaborate with diverse clients and support a wide range of products. For example, NorthX successfully scaled a client’s production from a few kilograms of product validation in the first year to an impressive 300 kg per year within four years.
Central to this success is the NorthX Innovation Hub, which is more than just a state-of-the-art platform for non-GMP and GMP manufacturing and analytics. It embodies NorthX’s commitment to partnering closely with clients, providing not only cutting-edge equipment and scientific expertise but also dedicated guidance at every stage. NorthX Biologics invests significant time and CMC expertise in each project, helping early-stage companies navigate complex development challenges and ensuring that they move seamlessly from concept through to GMP-compliant manufacturing. By prioritizing process knowledge, robustness, and tailored, phase-appropriate adaptations early on, NorthX Biologics ensures a smooth transition into large-scale production, with the confidence that comes from a deeply engaged, collaborative partnership.
The Innovation Hub also facilitates the exploration of new technologies that enhance NorthX’s contract development and manufacturing services, such as their proprietary plasmid platform. Its flexibility allows for rapid customization, helping clients swiftly move from concept to advanced development stages.
Embracing sustainability and innovation in Sweden’s scenic landscape
Nestled in the picturesque town of Matfors and complemented by its Stockholm facility, NorthX Biologics’ locations offer more than just advanced biomanufacturing capabilities — they represent a commitment to sustainability, innovation, and community. Matfors, with its pristine natural surroundings, is powered exclusively by green electricity, underscoring NorthX’s dedication to eco-conscious operations. The choice of location also places NorthX Biologics at the intersection of industrial excellence and academic collaboration, as both facilities are close to Sweden’s leading universities, creating strong connections with top-tier research and talent development. Reflective of this intellectually stimulating environment, 54% of NorthX’s employees hold a master’s degree or higher, highlighting the advanced educational background that underpins the company’s innovative capabilities.
This setting, combined with NorthX’s focus on sustainability, fosters an environment where innovation thrives. The Innovation Hub in Matfors embodies this ethos by offering clients cutting-edge technologies while minimizing environmental impact. Matfors isn’t just a beautiful place to work — it’s a strategic, sustainable site designed to meet the challenges of early-phase development and scale seamlessly to commercial manufacturing, making NorthX Biologics a partner for long-term success.
Ensuring high standards through an adaptive quality system
NorthX Biologics ensures the efficient production of both technical and therapeutic proteins by leveraging its extensive track record and experience, tailoring processes to meet the specific needs of each client and product. For therapeutic proteins, NorthX implements phase-specific controls and validations, while for technical proteins, controls are directly tailored to customer needs, ensuring the right level of traceability and control.
Therapeutic proteins are produced under Good Manufacturing Practice (GMP) guidelines to guarantee efficacy and patient safety. NorthX Biologics employs advanced analytical methods, automated systems, and rigorous quality assurance protocols to maintain stringent control throughout all stages of production. As a European facility, NorthX undergoes regular authority (MPA/EMA) and client inspections not only for commercial products but also for compliance with the high standards required across all production levels. This ensures that every batch, irrespective of its scale, meets the most stringent regulatory and industry standards, reflecting our commitment to delivering the highest quality therapeutic proteins.
Although technical proteins are not intended for clinical use, NorthX Biologics applies an effective quality system ensuring control and continuous improvement. Through comprehensive quality risk management, traceability, and detailed standard operating procedures, NorthX ensures consistent high quality in a cost-effective manner. During the COVID-19 pandemic, NorthX’s expertise and proactive measures led to a batch failure rate of less than 1%, even amid a sixfold increase in demand. Continuous monitoring, process optimization, and the expertise of highly skilled teams allow for seamless scalability without compromising the integrity or performance of the proteins, whether for therapeutic or technical applications.
In addition, NorthX Biologics leverages well-established technology platforms to minimize upfront development needs. This allows for the integration of necessary testing and validation at each production stage for therapeutic proteins, while ensuring more streamlined and cost-efficient production of technical proteins. By adopting automation, process innovation, and a robust quality management system, NorthX consistently upholds the highest standards across its operations.
Sustainability at the core of innovation
NorthX Biologics is deeply committed to sustainability, embedding eco-conscious practices into every facet of its production processes. We continuously optimize workflows to reduce waste, minimize energy consumption, and lower emissions, while integrating green technologies wherever possible. By enhancing process efficiency and relying solely on renewable energy sources, NorthX strives to significantly reduce its environmental footprint without sacrificing quality or cost-effectiveness.
NorthX’s dedication to sustainability extends beyond environmental responsibility, emphasizing social sustainability through active community engagement and educational initiatives. NorthX Biologics believes in contributing meaningfully to society by setting a high standard for ethical and responsible business practices within the life sciences sector. The company views competence development as a cyclical process — supporting individuals at the beginning of their careers, supporting mentoring interactions all the way through career development and, in turn, benefitting from unbiased creative minds spurring new ideas and fostering scientific advancements that contribute to the growth of the entire industry.
Advancing protein production with collaborative partnerships
Collaboration is a cornerstone of NorthX’s leadership in protein production, driving innovation through partnerships with forward-thinking organizations and customers alike. A notable example is our work with AdBIOPRO, a competence center led by the Royal Institute of Technology, the most prestigious technical University in Stockholm. This consortium, which includes the university and several companies, focuses on advancing bioprocessing by fostering idea exchange and collaborative problem-solving.
Through partnerships with academic institutions and industry leaders, NorthX Biologics taps into cutting-edge research and emerging technologies that enhance our processes, boost efficiency, and lead to the development of novel solutions. These collaborations nurture a culture of continuous learning and adaptability, allowing NorthX to stay responsive to evolving market demands. While our alliances are primarily at the national and European levels, NorthX Biologics is actively seeking to expand globally, particularly through new partnerships in the United States.
A partner for global biopharma success
With decades of experience, NorthX Biologics has recognized that flexibility and an unwavering commitment to quality are essential for success in protein production. Our experience has also highlighted the importance of scalability, staying ahead of technological advancements, and fostering strong, long-term partnerships that help our clients achieve their goals.
As demand for advanced therapies continues to grow, NorthX’s scalable infrastructure, particularly in Matfors, enables us to meet large-scale production needs. We are prepared to support customers throughout the entire process, from early development to full-scale commercial production, for both technical and therapeutic proteins.
By leveraging our production capacities, core competencies, and high-quality services in both technical and therapeutic proteins, NorthX Biologics is well-positioned to be a leading global partner for the biopharmaceutical industry. Our dedication to delivering high-quality, innovative solutions ensures that we remain at the forefront of this rapidly evolving sector.
Eva-Karin Gidlund, Ph.D., MBA Chief Business Officer
Northx Biologics
Eva-Karin Gidlund, Ph.D. MBA, is the Chief Business Officer at NorthX Biologics, where she spearheads global business strategy and drives biopharmaceutical innovation, particularly in cell and gene therapy. With a Ph.D. in medicine and genetics, she brings extensive experience in strategic leadership, business development, and alliance management across the biotech industry. Eva-Karin is passionate about building partnerships that accelerate company growth and is recognized for her expertise in organizational development and scientific communication. As a keynote speaker and TEDx presenter, she actively promotes cross-industry collaboration. She is also a dynamic leader in AI integration, contributing to her company’s competitive edge in the rapidly evolving life sciences sector.
NorthX Biologics is a pioneering Swedish contract development and manufacturing organization (CDMO) that combines deep-rooted scientific heritage with cutting-edge biotechnological advancements. Headquartered in Matfors with an additional facility in Stockholm, NorthX specializes in a wide range of biologics modalities, including proteins, nucleic acids, and viral vectors. The company’s Innovation Hub plays a central role in supporting the development of both traditional and advanced therapies, a vital testing ground for new programs and approaches. With a commitment to sustainability and community involvement, NorthX leverages proprietary technologies and development and manufacturing experience to provide services that go beyond the typical CDMO, pioneering novel approaches for both large and small clients. In this Q&A, Chief Executive Officer Janet Hoogstraate, Ph.D., discusses the strategic initiatives helping the company to comprehensively address the evolving needs of the biopharmaceutical sector, in conversation with Pharma’s Almanac Editor in Chief David Alvaro, Ph.D.
David Alvaro (DA):To begin, can you share the story of the origins of NorthX Biologics and the foundational vision driving the company?
Janet Hoogstraate (JH): NorthX Biologics was officially established in October 2021, although the facilities and its people have long been operational under different entities and leadership dating back to 1963. Our founding vision was to create a state-of-the-art facility here in Matfors, Sweden, with advanced capabilities for biologics, including proteins, RNA, and cell therapies, primarily aimed at empowering R&D projects and innovative therapies where manufacturing might not yet be established. This focus is crucial, especially for smaller biotechs and even larger companies where not every project can be accommodated.
We have been able to leverage the legacy experience and expertise of sites and teams from our predecessor companies, like Cobra Biologics, to deliver on this new vision. The acquisition of the Stockholm-based Clinical Trial Manufacturing unit from Valneva last year not only expanded the geographical footprint but also enhanced our technical expertise and capabilities, particularly in mammalian expression systems and viral vectors. This combination of heritage, innovation, and modern capabilities continues to shape NorthX’s unique culture and strength.
DA: What are the values that define NorthX Biologics and the company’s culture?
JH: At NorthX, we say, “We are small enough to care; big enough to deliver.” Although this is a borrowed phrase, it captures our core very well. True values must be demonstrated consistently by an organization, not merely stated. For us, caring is central, and that care manifests in our focus on customer relationships and partnerships, which are built to last and are foundational to our operations.
Innovation is also an important pillar. Our Innovation Hub was truly central to the inception of NorthX, and that dedication to innovation cascades from there across all of our operations.
Our long-standing site in Matfors is not just a workplace; it’s a community deeply rooted in the traditions of rural Sweden. This setting has shaped a strong culture of collaboration, where team dynamics and a collective ability to overcome challenges are key to our success. Our employees embody a tight-knit spirit that enhances our processes and drives continuous growth and development.
This emphasis on teamwork and community is integral not only locally but across all our interactions, playing a crucial role in successfully delivering projects. As we expand in Sweden and beyond, we continue to diversify our team. Successfully integrating a range of cultural backgrounds has enriched our company culture and bolstered our global operations. Our leadership team, with its diverse experiences from various industries, significantly contributes to our strategic and operational approaches, strengthening our internal capabilities and enhancing our position in the global market.
Reliability and experience underpin our ability to deliver on promises, ensuring that our partners can depend on us for both small-scale and large-scale projects.
DA:Are there any additional values or priorities you have personally brought to the company since your appointment as CEO last summer?
JH: I firmly believe in fostering a culture of accountability within the team. It’s crucial for me that team members feel empowered to make decisions independently while knowing they have my full support. This approach encourages a proactive rather than reactive decision-making process throughout the organization. I also strive to instill enthusiasm and engagement among our team members. Being genuinely engaged in what we do and helping each other succeed are fundamental principles I champion, and they drive the collective success and fulfillment of our roles.
DA:How are your core capabilities and services structured, and to what extent do you see them evolving in the near future?
JH: We describe our service as providing complete solutions. Whether it’s a large pharmaceutical company or a biotech startup with a groundbreaking idea needing clinical development, they may lack the necessary manufacturing expertise or capacity. That’s where we come in, offering a full CMC package that includes process and analytical development, manufacturing, quality control, quality assurance, and qualified person services.
We approach our services by dividing them into two main areas –– microbial and mammalian work –– each requiring specific expertise with some overlap. From there, we branch into various modalities like plasmids, mRNA, proteins, viral vectors, and cell therapies, but they all begin with the specific capabilities and expertise needed at the microbial and mammalian levels.
Looking forward, we are keenly observing the industry’s evolution. Our Chief Technology Officer Ola Tuvesson and his team stay actively engaged through collaborations, literature, and conferences to gauge emerging trends. Our goal is to evolve alongside our customers, ensuring that we are equipped with the right technologies to support their needs and ambitions, often before they even articulate them. This proactive approach allows us to adapt and potentially prioritize new modalities that align with market developments and client demands.
DA: What can you share about recent and forthcoming acquisitions and your overall growth strategy looking forward?
JH: Last year’s acquisition primarily aimed to enhance our mammalian capabilities, which were more developed at our Stockholm site compared with our headquarters in Matfors. This has significantly broadened our technical scope. Internally, we recognize that our technical capacity can be expanded by adding both personnel and new projects, so there is considerable potential for organic growth within our existing operations.
However, we are always looking for strategic acquisitions or partnerships that can extend our service offerings. When a new technology emerges that aligns with our customers’ needs, we evaluate whether to develop this capability in-house or through a company that brings the desired expertise and cultural fit. This proactive approach to potential acquisitions is a continuous focus for us.
Regionally, while we are rooted in Sweden and have traditionally served Nordic countries, we are actively expanding our presence in Europe and are increasingly looking toward the U.S. market. We have already established some key partnerships there and are committed to establishing a stronger customer base in the United States.
DA:Can you elaborate on the role of the Innovation Hub and its central role at NorthX?
JH: The Innovation Hub at NorthX is central to both our identity and strategy, not merely enabling early projects but providing state-of-the-art infrastructure for both non-GMP and GMP manufacturing. This includes cutting-edge techniques like mRNA manufacturing, allowing us to support innovative academic or biotech projects without the need for heavy investment in expertise or facilities. For example, we established an mRNA line in anticipation of its growing importance in modern therapies well before we had a specific project lined up.
The hub’s flexibility and responsiveness allow us to tailor our capabilities to customer needs swiftly, avoiding the typical delays of setting up complex equipment like reactors. It’s designed to quickly advance ideas from concept to next-phase development, offering researchers and startups the opportunity to work directly with our labs to move their projects forward and identify bottlenecks early on.
Moreover, our Innovation Hub serves as a testing ground for new technologies that may later integrate into our broader CDMO services. This includes proprietary technologies, such as our plasmids and our work with outer membrane vesicles.
This dual role of the Innovation Hub — supporting external innovation while enhancing our internal capabilities — ensures that we stay at the forefront of biotechnology, continuously integrating successful innovations into our manufacturing practices. It’s supported by Vinnova, Sweden’s innovation agency, which helps us stay connected to national and European research and funding networks, further enhancing our capacity to innovate. Through these efforts, we aim to offer complete solutions to clients of all sizes, helping them bring innovative therapies to patients. This is what drives us every day at NorthX.
DA:Are you working toward a specialized focus in one or more of your capabilities or aiming to remain remaining flexible to change in order to meet various customer needs and market demands?
JH: At NorthX, we operate within the advanced biologics sector, focusing primarily on GMP standards, although we also engage in non-GMP processes as steps toward concept testing and clinical manufacturing. Our capabilities encompass preclinical, clinical, and commercial manufacturing, enabling NorthX to support our clients throughout the entire development process. We clearly emphasize versatility and adaptability in our offerings. For instance, if a particular modality doesn’t see expected demand or market interest within a couple of years, we’re prepared to shift our focus. Our approach is to balance market demands with anticipated trends, ensuring that we can swiftly adapt and align our capabilities with emerging needs and opportunities in the biotech field.
DA:Could you discuss any current strategic alliances or partnerships that are crucial to NorthX’s success?
JH: Certainly, our strategic alliances are integral to our growth and innovation. Our engagement with immuno-oncology company Mendus illustrates our commitment to advancing cell therapy solutions for acute myeloid leukemia, reflecting our ability to tackle complex biologics manufacturing. Our work on outer membrane vesicles with vaccine development company Abera Biosciences not only advances novel biotechnological approaches but also supports our strategic focus on non-viral delivery systems as a promising alternative to conventional viral methods.
Another strategic collaboration has been the recently completed OPENCORONA project (OPENCORONA | Karolinska Institutet), developing a DNA vaccine all the way to testing in humans, which was led by the Karolinska Institute, located near our Stockholm site. This project not only enhanced our connection with top European researchers from countries like Germany and Italy but also strengthened our network within a broad European alliance.
Additionally, we are part of AdBIOPRO, a competence center driven by the Royal Technical University in Stockholm, where we collaborate with several companies and the university itself to enhance bioprocessing techniques like cell culture processes. This consortium allows us to exchange ideas and tackle common challenges openly, enhancing our processes and solutions.
These collaborations are predominantly at the national and European levels, but we are actively looking to expand our alliances to include partners in the United States, which is still in the early stages. These strategic partnerships are vital as they foster innovation and allow us to stay at the forefront of technological advancements in the biopharmaceutical industry.
DA:One innovative area you mentioned is non-viral delivery systems. How do you view their potential?
JH: Viral delivery systems received considerable attention in the development of gene therapies, but there remains a degree of skepticism about their widespread application beyond infectious diseases and vaccines. This opens the door for the development and integration of non-viral delivery methods, which I believe are crucial for diversifying treatment options. For example, our involvement developing and manufacturing a DNA vaccine as part of the OPENCORONA consortium included techniques like electroporation, which, while not a universal solution, illustrates the potential for physical methods of delivery.
We are exploring various non-viral approaches, such as outer membrane vesicles and lipid particles, which are less immunogenic and toxic and thus provide a potentially safer alternative to traditional viral methods. These innovations are promising not only because they offer a counterbalance to viral delivery’s limitations but also because they expand capabilities in biologics, making treatments more adaptable and less prone to causing immune reactions. As these technologies mature, they will become increasingly important to our strategy, complementing our existing suite of solutions and potentially leading the way in next-generation biopharmaceutical development.
DA:As the pharmaceutical industry begins to move toward more personalized and precision therapies, how is NorthX preparing to adapt to these emerging demands for smaller, more individualized batch production?
JH: NorthX is actively preparing for the shift toward more personalized therapies, particularly in cell therapy, which by nature requires a more tailored approach. For instance, while it isn’t itself a personalized therapy, the allogeneic cell therapy we produce for Mendus is manufactured with technology that aligns well with the personalized therapy model.
Additionally, we are assessing the potential for personalized therapies at our Matfors facility to ensure the rapid turnaround times that such treatments require. Looking ahead, it’s clear that the broader adoption of personalized therapies will necessitate a significant focus on cost reduction, both in clinical and manufacturing contexts. As the industry progresses, and potentially hundreds of cell and gene therapies become registered, managing and minimizing costs will become even more critical. This focus on cost-efficiency is likely to become an integral part of the innovation environment as we adapt our facilities and processes to accommodate these evolving demands.
DA:Sustainability is increasingly becoming a priority in biopharma. Can you discuss how NorthX is addressing sustainability in its operations and the importance of these efforts both for your customers and internally?
JH: Sustainability is a critical component of our operations and is deeply valued by our customers and staff.
We are committed to using only green energy and meticulously managing our waste, aiming to minimize our environmental footprint. We also balance the use of single-use systems with stainless steel in manufacturing to mitigate the environmental impact, particularly where single-use systems can be avoided.
Beyond environmental considerations, we emphasize social sustainability through various community engagement and educational initiatives. We actively participate in local and national educational programs, contributing to leadership development and fostering career opportunities for students, which aligns with our broader commitment to societal improvement.
Moreover, our approach to sustainability isn’t just about minimizing harm; it’s about actively contributing to the community and setting a standard for responsible business practices in the life sciences sector. I believe it’s essential to give back –– I see competence development as a circular process, both in regard to sharing experiences to support people in the beginning of their careers and fostering further scientific advancements. This holistic view on sustainability — spanning from green practices to social responsibility — is integral to our mission and is increasingly recognized as vital by our customers.
DA:To wrap things up, how do you see NorthX building upon your foundation and your current differentiators and continuing to evolve along with your customers?
JH: At NorthX, our philosophy is encapsulated by the phrase “Beyond CDMO.” We aim to be more than just a contract development and manufacturing organization; we focus on understanding our clients’ needs and growing alongside them throughout their development journey. This approach means we don’t just execute prescribed tasks; we engage deeply with our clients, fostering strong, lasting relationships whether the clients are large or small. This commitment to client-centric partnerships is what truly differentiates us in the industry.
Looking ahead, the biologics manufacturing landscape is poised for significant changes, driven by advancements in personalized medicine and other emerging modalities. We see ourselves continuing to be at the forefront of developing and manufacturing complex proteins and cell and gene therapies. Another area we are keenly focusing on is how our Innovation Hub and manufacturing capabilities can enable pandemic preparedness, ensuring that regions and countries are better equipped for future health crises, a direction that has gained momentum since the COVID-19 pandemic.
Overall, our goal is to lead in innovation and adaptability, staying ahead of industry trends and aligning our capabilities with the evolving needs of the biopharmaceutical sector.
A recent article in BioStock details how Lipum has begun the manufacturing process of SOL-116 for Phase II studies, in partnership with NorthX Biologics, a leading manufacturer of advanced biological drugs. SOL-116 is a monoclonal antibody that inhibits Bile Salt-Stimulated Lipase (BSSL), a protein crucial for sustaining chronic inflammation, initially targeting rheumatoid arthritis. The production of biological drugs is complex and costly, requiring precision and long lead times. Lipum chose NorthX Biologics as their contract manufacturer to reduce costs and lead times while maintaining high quality.
The collaboration involves NorthX Biologics handling the entire manufacturing process, including cell cultivation, scaling up, purification, quality control, vial filling, analytical work, and stability studies. The manufacturing process is expected to take 18 months and has already begun. NorthX Biologics has extensive experience in manufacturing biological drugs and offers a cost-effective, comprehensive solution for both the drug substance and sterile fill-finish. The partnership aims to bring this therapy closer to patients.
The pharmaceutical and biotech industries are experiencing a paradigm shift that is redefining the roles and responsibilities of Contract Development and Manufacturing Organizations (CDMOs). Over the past few decades, these organizations have transitioned from being mere service providers to becoming essential partners in the drug development and manufacturing process. We at NorthX Biologics, a company that has been engaged in pharmaceutical manufacturing since 1963, have witnessed firsthand how the landscape has transformed—particularly in the realm of advanced biologics. This transformation is not just about scaling up operations; it’s about redefining relationships, expectations, and outcomes.
The shift from transactional to partnership-based models
Historically, CDMOs were seen primarily as external contractors—a means to an end for pharmaceutical companies that required additional capacity or specialized expertise. These relationships were often transactional, with clear boundaries between the client and the service provider. The CDMO was expected to deliver a specific product or service, with little room for collaboration beyond the agreed-upon terms.
However, as the industry has matured, it has become increasingly clear that this transactional model is insufficient to meet the demands of modern drug development, particularly in the context of advanced biologics. Today, there is a clear shift towards partnership-based models, where CDMOs and their clients work hand-in-hand throughout the entire drug development lifecycle—from early-stage development through to commercialization and beyond.
At NorthX Biologics, we have evolved from our roots in traditional medicine production to become a leader in advanced biological manufacturing. This evolution has been driven by several factors:
Increasing complexity of biologics: Unlike small molecules, which are relatively straightforward to manufacture, biologics are complex, large-molecule drugs derived from living cells. Their development and production require a deep understanding of biology, chemistry, and engineering, as well as a high degree of precision to ensure product stability and consistency across batches.
The rise of personalized medicine: Personalized medicine, including therapies tailored to individual patients’ genetic profiles, is becoming more prevalent. This requires a more flexible and responsive manufacturing process, where the CDMO must be able to quickly adapt to the specific needs of each therapy.
Demand for innovative therapies: The biotech industry is increasingly focused on developing cutting-edge therapies such as cell, gene, and mRNA therapies. These therapies require specialized manufacturing processes that go far beyond the capabilities of traditional small molecule production. As such, the role of the CDMO has expanded to include not just manufacturing, but also process development, regulatory support, and even post-market surveillance.
As a result of these factors, CDMOs like NorthX Biologics are no longer just service providers—we have become integral partners in the drug development process. This shift towards partnership-based models has profound implications for both CDMOs and their clients.
Advanced biologics: More than just a product
The production of advanced biologics is fundamentally different from the manufacturing of small molecules, and this difference has significant implications for the relationship between biotech companies and CDMOs.
Small molecule drugs are often straightforward chemical compounds that can be mass-produced using well-established processes. In contrast, biologics are complex drugs made from living cells. These drugs are not just products—they are processes. The manufacturing of biologics involves numerous steps, each of which must be carefully controlled to ensure the final product meets the necessary quality standards.
Moreover, biologics are highly sensitive to changes in their manufacturing environment. Even minor variations in the production process can lead to significant differences in the final product, which can affect its safety and efficacy. This complexity means that biologics manufacturing is not a one-size-fits-all service. Each biologic is unique, requiring a tailored approach to development and production.
This is where the traditional fee-for-service model, commonly used in small molecule production, falls short. In the world of biologics, you’re not just purchasing a product; you’re engaging in a collaborative process that involves ongoing dialogue, adaptation, and problem-solving between the biotech company and the CDMO. At NorthX Biologics, we have embraced this collaborative approach, recognizing that the successful development of advanced biologics requires a partnership mindset.
The importance of integrated services
In the rapidly evolving biotech industry, the ability to offer integrated services has become a key differentiator for CDMOs. As highlighted in the recent WittKieffer report (1), CDMOs that can provide end-to-end services—from process development to commercial-scale manufacturing—are increasingly in demand.
However, it’s not just about the breadth of services offered; it’s about how well these services are integrated and executed. A CDMO that can seamlessly coordinate activities across different departments and sites can significantly reduce the time and cost associated with drug development. This is particularly important in the early stages of development when processes and methods are still being refined.
For example, knowledge transfer is a critical component of the drug development process. Ensuring that insights gained during early-stage development are effectively communicated to the teams responsible for later stages can make the difference between hitting a critical milestone or facing costly delays. Similarly, close collaboration between the CDMO’s regulatory and manufacturing teams can help ensure that the final product meets all necessary regulatory requirements, thereby reducing the risk of delays during the approval process.
At NorthX Biologics, we have integrated our services across all stages of drug development and manufacturing, from early-stage process development to full-scale commercial production. This integrated approach has allowed us to provide our clients with the agility and expertise needed to navigate the complexities of biologics manufacturing, ultimately accelerating time-to-market for their products.
The leadership imperative
The shift from transactional relationships to partnership-based models also demands a new kind of leadership within CDMOs. As the WittKieffer report (1) points out, the traditional business-focused leadership model may no longer be sufficient to navigate the complexities of today’s market.
In the past, CDMO leadership was often focused on operational efficiency and cost control. However, as the role of CDMOs has evolved, so too have the demands placed on their leaders. Today’s CDMO leaders must be able to drive digital transformation, embrace sustainability, and manage the unique challenges posed by novel modalities like gene and mRNA therapies.
For biotech companies, this means choosing a CDMO partner with the right leadership—one that not only has the technical expertise but also the strategic vision to guide projects to success in a fast-paced, ever-changing environment. The right leadership can make the difference between a successful partnership and one that falls short of expectations.
At NorthX Biologics, our leadership team is committed to driving innovation and excellence in all aspects of our operations. With over six decades of experience, our evolution from traditional medicine manufacturing to advanced biologics production has been guided by a leadership ethos that prioritizes collaboration, agility, and strategic foresight. This leadership approach ensures that we are not only meeting the needs of today’s market but also anticipating the challenges and opportunities of tomorrow.
Conclusion: Choosing the right CDMO partner
As we look to the future, the role of CDMOs will continue to evolve, becoming even more integral to the success of drug development programs. For emerging biotech companies, selecting the right CDMO partner is not just about finding a provider with the right capabilities. It’s about finding a partner with whom you can build a long-term, collaborative relationship—one that is based on trust, shared goals, and a deep understanding of the complexities involved in biologics manufacturing.
In this new era, the choice of a CDMO is more critical than ever. It’s not just about what they can do for you today, but how they can help you navigate the challenges and opportunities that lie ahead. The right partner will not only help bring your product to market but will also play a crucial role in your company’s growth and success.
At NorthX Biologics, our history of innovation and commitment to excellence positions us as the ideal partner for biotech companies navigating the complex landscape of advanced biologics. With a legacy that spans over six decades, we understand that the path to success is paved with collaboration, expertise, and a shared vision for the future. As your CDMO partner, we are dedicated to helping you achieve your goals and drive meaningful impact in the world of healthcare.
NorthX Biologics is an established provider of process development and manufacturing services with expertise in the biologics used in vaccines, gene therapy and other advanced applications. Headquartered in Matfors in central Sweden, the company has been manufacturing biologics to GMP since 1992, with a proven track record of converting early-stage processes into manufacturing processes suitable for clinical applications and on into commercialization.
In the dynamic and complex world of pharmaceuticals and drug development, the quest to find the right Contract Development and Manufacturing Organization (CDMO) often feels akin to searching for a life partner. As a person often facing and meeting the companies scouting for a CDMO I have heard this analogy so many times. This kind of partner hunt it’s a journey filled with careful considerations, weighing options, and seeking that perfect match that aligns with your unique innovation needs. It is a in a way a “do we have the chemistry” test without pointing to the real type of chemistry. This intricate process, surprisingly like finding a soulmate, requires more than just a scientific approach – it’s about understanding, compatibility, and a shared vision.
The romanticized idea of finding “the one” in a world brimming with potential partners parallels the challenges in the CDMO landscape. Just as there’s no single destined soulmate for each individual, the notion of one perfect manufacturing partner amidst a plethora of providers is equally unrealistic. In both scenarios, numerous potential partners could foster healthy, productive relationships. However, the selection process in the biotech industry involves less emotion and more objective evaluation (hopefully!), focusing on specific criteria that align with a company’s strategic goals.
Embarking on this ‘dating’ journey with CDMOs means engaging in a series of ‘dates’ – site visits, audits, and meetings that are crucial for understanding each other’s capabilities, goals, and values. At NorthX, we have learned that compatibility, trust, and shared objectives are paramount for a successful partnership. Just like in personal relationships, these factors heavily influence the selection process. It takes a lot and is not easy to be able to show the true side, the naked truth in this dating game, but this is where transparency really has its purpose. As a customer you can set quite high expectations and as a CDMO representant it means that you need to know your whole organization and trust your organizations to its full potential. Therefore being big is not always better in the CDMO space.
In the world of CDMO selection, it’s not just about the allure of state-of-the-art facilities or advanced bioreactors (a shiny new thing might of course be an extra plus). The real connection lies in the less tangible yet critical aspects like shared vision, trust, and effective communication. These elements form the heart of a strong partnership. For instance, financial compatibility and transparency are as vital in this relationship as they are in personal life, ensuring that your project’s budget aligns with the CDMO’s pricing structure.
The team behind the CDMO plays a role comparable to meeting a partner’s family. Their collective expertise, dedication, and collaboration will significantly impact the success of your project. This is especially true in the unique nature of biologics manufacturing, where precision, understanding, and a collaborative spirit are essential. The recent consolidation in the CDMO market, resulting in fewer but more diverse providers, has introduced new dynamics in the selection process. This change has led to providers acquiring additional capabilities (horizontal integration) or adding upstream or downstream services (vertical integration). These integrations promise simplicity and speed, but as a actor open to meet your perfect match you should sometimes instead look for added technical benefits. Adding on also challenge the internal work structure and communication. This internal communication is so important and the mutual respect that different departments must display is crucial for an efficient scale up, scale out and transfer. So when you are dating, please dare to test the culture and climate of your CDMO, do not satisfy with “ most convenient”. Be mindful of potential red flags indicating incomplete integration or separate operation of teams within a CDMO, but do not judge without asking about it. Even though a meeting with a “convenient” person can lead to a flourishing long lasting relationship, it is quite rarely. You should not choose your life partner because this person was just the easiest one to get hold of or the only one still standing at three o’clock when you are walking home. Referrals is so underestimated, it should be the core if possible. By using your existing network you add a layer of security, someone has already done the screening, and when it comes to CDMOs I would really recommend dating your best friends friend rather than blind dates ( meeting a stranger).
When you meet “the family “ for the first time, you need to embrace all the members of the family. A family dinner is never pleasant when some persons in the family do not really get a long, and if the family is very big the possibilities for this kind of stressful family gatherings increases. Such nuances can reveal much about the internal culture and operational effectiveness of a CDMO.
During my years I have also encountered a lot of smaller biotech companies telling me about how they were not satisfied with their CDMO, but despite lack of trust and a lot of water under the bridges they choose to come back, year after year. This kind of bouncing back to your ex might seem like a really easy thing to do, you know what to expect and what you get, and you just started to hope that the ex had changed and became this prince/princess that you at first thought he/she was. But honestly, bouncing back seldom gives you the “happily ever after”. From a statistical point of view this reunition with your ex/former CDMO might have a 50/50 success rate,but it might also end up in you judging and he/she not being pleased with the way you communicate? This bouncing back can sometimes delay projects ( material to start clinical trial etc) more than actually moving and changing partner even though you always add time doing a new Tech Transfer.
In conclusion, selecting the right CDMO is akin to finding a long-term, committed life partner in the personal realm. It’s a decision that extends beyond the immediate, tangible aspects to the core of shared values, goals, and mutual understanding. This choice not only impacts your immediate project needs but also sets the stage for long-term success in the evolving world of therapeutic biologics. As you navigate this ‘dating’ landscape, remember that the right match is out there – a CDMO that understands your vision, aligns with your goals, and stands ready to join you in advancing healthcare innovation. Lets find the one, Lets Journey Together!
As the pharmaceutical and biotechnological industries are obliged to align their operations with Good Manufacturing Practice (GMP) guidelines, a unique set of challenges emerges for facilities tasked with producing non-GMP proteins. GMP is widely recognized as the gold standard for ensuring that products are consistently produced and controlled according to quality standards. However, in some cases, the production of non-GMP proteins (or “technical proteins), often required for research, industrial applications, or other non-clinical purposes, becomes a necessity. At NorthX we serve both the non-gmp and GMP protein communities and place a strong emphasis on utilizing a strong Quality Management System, while at the same time respecting the process for each product.
Producing these proteins efficiently within a predominantly GMP-driven environment poses several challenges:
Segregation
Both GMP and non-GMP processes have their distinct sets of protocols and standards. Applying spatial, procedural or time-based segregation between GMP and non GMP products is essential. In cases where GMP manufacturing is the prevailing standard this will also stipulate how and what is needed to be done so ensure this segregation. Normally is not allowed to produce more than one pharmaceutical product at a time in a multipurpose facility and thorough product change over routines need to be in place to ensure the risk for carry overs and mix ups are minimized also contributing to the integrity and high quality of the non GMP protein manufactured.
Documentation dilemmas
GMP operations thrive on meticulous documentation. Every step, change, or deviation is carefully recorded. While non-GMP production doesn’t demand the same level of rigorous record-keeping, facilities must strike a balance. Too little documentation for non-GMP processes can lead to inefficiencies or inconsistencies, while over-documenting can unnecessarily tie up resources.
Training and personnel challenges
Staff trained predominantly in GMP protocols might find it challenging to switch gears for non-GMP production. The mindset and attentiveness required for GMP can be deeply ingrained, making it difficult to adapt to the more flexible requirements of non-GMP production.
Resource allocation
In a facility primarily designed for GMP production, resources – be it equipment, personnel, or space – are typically allocated with GMP requirements in mind. Efficiently producing non-GMP proteins requires a rethinking of these allocations without compromising GMP production.
Cross-contamination concerns
Even with segregation in place, the risk of cross-contamination always looms. It is therefore important that the superior quality system stipulates what operations is needed to be in place and what measures to take between batches. Ensuring that non-GMP proteins don’t compromise the quality of GMP products is paramount.
Regulatory scrutiny
Regulatory bodies, aware of the potential risks, might subject such dual-purpose facilities to heightened scrutiny. This can lead to more frequent inspections and audits, creating additional pressure on the facility to demonstrate clear demarcation and control over its two types of production.
Efficiently navigating the duallandscape
While the challenges are significant, they’re not insurmountable. With strategic planning and a clear understanding of both GMP and non-GMP requirements, facilities can effectively navigate this dual Tailored Training Programs: Implement training modules specifically designed to address the nuances of working in a dual production environment.
Robust Quality Management Systems (QMS): Implement a QMS that can adapt to both the rigorous demands of GMP and the flexibility of non-GMP.
Regular Internal Audits: Periodically review and assess the efficacy of the separation strategies in place.
The expanding horizons of non-GMP technical proteins: A deep dive
In the biopharmaceutical arena, the importance of Good Manufacturing Practice (GMP) often takes center stage. However, beyond this GMP-centric world lies an equally essential category of proteins known as “industrial” or “technical proteins”. While they might not be used directly in therapeutic applications, they serve a myriad of functions that propel innovation and understanding in biotechnology. Let’s explore the expanding applications of these technical proteins.
1. Enzymes
Enzymes are the meticulous craftsmen of the biological world. They speed up chemical reactions, sculpt molecules, and construct or deconstruct various compounds. Their role in biotechnology is diverse:
Biocatalysis: Enzymes, with their ability to catalyze reactions under mild conditions, offer eco-friendly alternatives in chemical synthesis. They’re used in producing biofuels, fine chemicals, and even pharmaceutical intermediates.
Biomolecular Engineering: Restriction enzymes, ligases, and polymerases are the workhorses of genetic engineering, enabling DNA manipulation and amplification.
Industrial Applications: From the enzymes in your laundry detergent that break down stains, to those in the food industry aiding cheese production, these proteins have a multitude of commercial applications.
2. Ligands
Ligands are molecules that can bind to other specific molecules. In biotechnology, protein ligands have invaluable roles:
Affinity Chromatography: Protein ligands are used to purify other proteins or molecules. They bind to the target molecule, enabling its separation from a mixture.
Diagnostics: Ligands play a central role in many diagnostic tests. For instance, they can capture specific biomolecules, indicating the presence or absence of a disease marker.
Biosensors: Ligands are vital for the development of sensors that can detect specific molecules, from toxins in the environment to glucose in blood.
3. Analytical proteins
These proteins are indispensable for research, diagnostics, and quality control:
Reporter Proteins: Proteins like Green Fluorescent Protein (GFP) are used to track gene expression, protein localization, and even monitor cellular events in real-time.
Quality Control: Proteins employed in assays ensure that therapeutic products are consistent, potent, and free from contaminants.
Drug Development: Proteins used in assays can screen potential drug candidates, assess their efficacy, or gauge potential side effects.
4. Structural and functional probes
To understand the complex dance of life at the molecular level, proteins are used as probes:
Protein Crystallization: Some proteins can induce crystallization of other proteins or large complexes, aiding in their structural determination.
Functional Assays: Proteins can be used to test the function of other molecules, be they drugs, other proteins, or even whole cellular pathways.
Championing the value of technical proteins
While the biopharma industry and regulatory bodies necessarily emphasize GMP due to its direct implication on human health, the role of technical proteins cannot be understated. They serve as the unsung heroes, facilitating innovation, preliminary testing, and foundational research.
As the industry continues to evolve, so will the applications of these non-GMP proteins. By understanding and championing their value, we can ensure that both the R&D and GMP spheres of biotechnology and pharmaceuticals continue to thrive and innovate hand in hand. The future is bright, and technical proteins will undoubtedly play a significant role in illuminating the path forward.
Have a technical protein in mind? We would love to discuss with you how to move your project forward. Please email us at contact@nxbio.com to learn more!
