Proteins Archives - NorthX Biologics

From lab to clinic: Large-scale recombinant protein production explained

Recombinant protein manufacturing has transformed biotechnology, enabling the production of therapeutic proteins, industrial enzymes, and bioengineered materials. The growing demand for recombinant proteins across regenerative medicine, disease diagnostics, and biopharmaceuticals has enhanced the importance of Contract Development and Manufacturing Organizations (CDMOs). These organizations bring essential expertise in process development, regulatory compliance, and large-scale production, ensuring the delivery of high-quality recombinant proteins. This review examines the critical role of CDMOs in optimizing recombinant protein manufacturing, exploring current challenges, innovations, and future advancements.

Bridging the gap between research and the patient

CDMOs serve as a crucial link between research institutions and commercial biomanufacturing by providing specialized services such as expression system optimization, purification strategies, and adherence to Good Manufacturing Practice (GMP) standards. CDMOs play a critical role in optimizing these expression platforms, ensuring high-yield, scalable, and regulatory-compliant production. These vital contributions in advancing recombinant protein production have a profound impact on the biopharmaceutical industry. As the demand for high-quality, scalable protein production escalates, CDMOs continue to be instrumental in providing dependable solutions.

Recombinant protein manufacturing

Recombinant protein expression is a cornerstone of scientific research and biopharmaceutical development, offering versatile solutions across various therapeutic applications. Bacterial and mammalian cell systems remain the most widely used platforms, each with distinct advantages.

Bacterial expression systems, particularly Escherichia coli, remain a cornerstone of recombinant protein production due to their rapid growth, ease of genetic manipulation, and cost-effectiveness. These systems offer high expression efficiency, making them ideal for large-scale manufacturing of simple proteins, enzymes, and non-glycosylated therapeutic proteins. However, bacterial hosts lack the intricate post-translational modification (PTM) machinery found in eukaryotic cells. This limitation can impact the correct folding, disulfide bond formation, and glycosylation of complex proteins, potentially affecting their functionality. Despite these challenges, bacterial systems continue to be a preferred choice for applications where process duration, scalability, and cost efficiency are paramount.

Mammalian cell systems, such as Chinese hamster ovary (CHO) and human embryonic kidney (HEK293) cells, are the gold standard for producing complex biopharmaceuticals. These platforms excel in generating proteins with native folding, proper post-translational modifications (PTMs), and human-like glycosylation—key factors in ensuring the efficacy and safety of monoclonal antibodies, recombinant vaccines, and other therapeutic proteins. With well-optimized expression technologies, mammalian systems offer a reliable and scalable solution for producing high-quality biologics, making them essential for advancing next-generation therapeutics.

A comprehensive approach to GMP-compliant large-scale recombinant protein production

Biopharmaceutical CDMO NorthX Biologics specializes in bacterial and mammalian cell culture processes for recombinant protein production. When embarking a new client project, a team of experts takes the gene sequence through gene cloning, cell bank generation, protein expression to final isolation and purification.

Expression system selection
Choosing the appropriate expression system is a critical factor in recombinant protein production. CDMOs assess various elements such as yield, scalability, and post-translational modifications to select the optimal system. Commonly used expression hosts include:
- Bacterial systems (e.g., Escherichia coli): Offer high expression efficiency but are limited in terms of post-translational modifications
- Mammalian cells (e.g., CHO, HEK293): Preferred for producing complex biopharmaceuticals due to their ability to perform human-like modifications

Process development
Co-funded by the Swedish Government, the Innovation Hub aims to advance infrastructure for advanced therapies and drive innovation in the biopharmaceutical sector. NorthX Biologics provides a clear distinction between non-GMP process development and GMP manufacturing, ensuring a seamless transition from early-stage development to full-scale, regulatory-compliant commercial production. An integrated approach across both upstream and downstream processes supports the production of high-quality recombinant proteins for advanced therapies.

2.1 Upstream process development
Efficient bacterial and mammalian cell culture processes are essential for maximizing recombinant protein production. Upstream process development focuses on optimizing media, fed-batch strategies, and bioreactor scale-up to improve protein yield and scalability. These processes are designed to ensure flexibility and efficiency in early-stage development.

2.2 Downstream process development
Downstream process development utilizes advanced chromatographic and filtration techniques to ensure high protein purity and yield. Chromatography resin screening, affinity chromatography, ion exchange, size exclusion chromatography and multimodal chromatography (MMC) are employed to refine and optimize protein purification for a variety of biopharmaceutical applications. This stage is critical in developing the optimal purification workflow before scaling up to GMP manufacturing.
GMP Manufacturing
3.1 Microbial protein expression
NorthX Biologics specializes in microbial development and GMP-compliant protein expression, offering tailored solutions for the development and production of microbial proteins across a wide range of applications, including therapeutics, vaccines, and industrial uses. With advanced facilities and extensive expertise, flexible manufacturing options for both GMP and non-GMP applications are provided, ranging from fully closed single-use systems to cost-effective large-scale stainless-steel plants, supporting batch sizes from milligrams to kilograms. A long experience in producing extracellular, intracellular and periplasmic proteins ensures high-quality, soluble protein expression or inclusion body production, all while meeting the specific requirements of GMP manufacturing.

3.2 Mammalian protein expression
NorthX Biologics has deep expertise in the development and GMP-compliant manufacturing of proteins expressed in mammalian systems, with a strong focus on optimizing both upstream and downstream processes to ensure high yields and product quality. A comprehensive range of GMP-compliant mammalian protein production services is offered, including adherent and suspension-based manufacturing systems. Adherent manufacturing capabilities, using cell lines such as HEK293, are fully optimized for effective GMP translation, supporting scales from T-flasks to 500m² fixed-bed reactors for seamless scale-up. For suspension cell lines like CHO, HEK293, and PerC6, a variety of GMP-compliant options, including shake flasks, wave-mixing bioreactors, and single-use stirred tank bioreactors, are provided, all operated in batch, fed-batch, or perfusion modes.

GMP compliance and quality control
NorthX Biologics offers comprehensive biopharmaceutical testing services with customized solutions designed to meet the unique needs of each product, including analytics services. Batches produced meet stringent regulatory standards for clinical or commercial applications through quality control measures, including:
- Process validation to ensure consistency in protein expression and purification
- Analytical characterization using techniques such as ELISA and HPLC for functional validation
- Adherence to GMP standards (Ph. Eur./USP), including the implementation of standard operating procedures (SOPs) for traceability

Quality assurance and regulatory compliance
NorthX Biologics ensures that all recombinant protein manufacturing adheres to regulatory requirements, ensuring compliance with FDA, EMA, and ICH guidelines. This can be achieved through:
- Process validation
- Analytical characterization and rigorous quality testing
- Full GMP compliance to meet regulatory expectations

Selective challenges in recombinant protein manufacturing

While significant progress has been made, CDMOs continue to face several challenges, including:
- Process scalability: Managing the transition from lab-scale to commercial-scale production while maintaining consistency and quality
- Protein aggregation: Overcoming stability issues that may affect protein formulation and storage
- Regulatory variability: Adapting to the evolving landscape of global regulatory standards

Closing thoughts: The strategic value of CDMOs in protein production

Selecting the appropriate recombinant protein expression system is crucial for driving both scientific research and biopharmaceutical advancements. Whether utilizing bacterial or mammalian platforms, each offers unique benefits aligned with specific project needs. For CDMOs like NorthX Biologics, effectively applying their expertise in expression systems and advanced bioprocessing technologies is essential to deliver high-quality, scalable, and GMP-compliant solutions.

By collaborating with researchers and companies, NorthX Biologics plays a pivotal role in optimizing the development of therapeutic proteins, monoclonal antibodies, and other biologics, ensuring successful commercialization. Through their commitment to regulatory compliance and technical expertise, NorthX Biologics is a key partner in advancing next-generation therapies that improve patient outcomes globally.

Naresh Thatikonda, PhD
Scientist
NorthX Biologics

Naresh, a Scientist at NorthX Biologics and SME at our Matfors facility, holds a PhD in Biotechnology and a MBA in Industrial Management and Economics. He joined NorthX Biologics in 2019, where he has been providing process and CMC support for the GMP manufacturing of drug substance (DS) and drug product (DP), contributing to the production of biological drugs for clinical trials.

References

Thatikonda, N. (2018). Functionalization of spider silk with affinity and bioactive domains via genetic engineering for in vitro disease diagnosis and tissue engineering (Doctoral dissertation, KTH Royal Institute of Technology).

U.S. Food and Drug Administration. (2023). A Quick-Start Guide to Biologics Manufacturing. Retrieved from https://www.fda.gov/media/170955/download

BiologicsCorp. (2013). A Guide to the Production of Recombinant Proteins. Retrieved from https://biologicscorp.com/wp-content/uploads/2013/05/A-Guide-to-the-Production-of-Recombinant-Protein.pdf

Protein science and the future of biotherapeutics

The study of proteins is transforming our understanding of human biology and disease, enabling breakthroughs in diagnostics, drug development, and advanced therapies. In this article, Mathias Uhlén, Professor of Microbiology at KTH Royal Institute of Technology and member of NorthX Biologics’ Board of Directors, explores:

The Human Protein Atlas: A cornerstone for drug discovery and development.

AI’s role in accelerating protein structure prediction and molecular interactions.

Next-generation technologies revolutionizing diagnostics and therapeutic monitoring.

NorthX Biologics’ innovation hub driving scalable, efficient protein production.

Join the journey into the future of protein science and learn how these advancements are shaping the next generation of precision medicine and therapeutic development.

The study of proteins is revolutionizing our understanding of human biology and disease. Advances in high-throughput protein analysis and AI-driven modeling are not only accelerating diagnostics and drug development but also paving the way for groundbreaking therapies and a future of fully in silico drug discovery. Explore how these innovations are transforming the landscape of biopharmaceutical science and opening new frontiers in precision medicine.

From the genome to the proteome: the rise of the human protein atlas

While genomics serves as the blueprint for human life, it is proteins that offer the most insight to help unlock our understanding of human biology and disease. Advances in DNA sequencing enabling the sequencing of the human genome in the early 2000s paved the way for new insights into proteins, which are the targets for nearly all pharmaceutical drugs and diagnostics. This critical role made the development of high-throughput protein analysis tools a logical and urgent next step.

After the completion of the Human Genome Project in 2001, researchers began leveraging its findings to systematically study human genes coding for proteins. Estimated at the time to be around 30,000, already far lower than had been anticipated before the sequencing project, the number of protein-coding genes was later refined to slightly more than 20,000. Over the subsequent decade, antibodies were synthesized to bind specifically to the products of these genes. Approximately 20 new antibodies were created daily, resulting in a total of 60,000 antibodies. Alongside this, 12 million certified pathology images were generated, capturing the interaction between these antibodies and their target proteins across a range of cell and tissue samples. This massive data collection effort spanned multiple global sites, including Sweden, China, South Korea, and India, and culminated in the creation of the Human Protein Atlas.

A key challenge in this initial phase was ensuring the specificity and reliability of the synthesized antibodies. To address this, researchers generated multiple antibodies for each protein, targeting different segments to confirm binding patterns. Rigorous validation of the data was conducted using complementary genomic and transcriptomic analyses, including RNA profiling, to ensure accuracy. This meticulous process took an additional 10 years.

Today, the Human Protein Atlas stands as an unparalleled resource for the scientific community, encompassing five million open-access web pages and hosting 12 million images. It is the largest biological information repository globally and attracts approximately 500,000 visitors each month. Nearly all pharmaceutical companies and academic institutions routinely consult the Protein Atlas, making it a cornerstone for drug target identification and development.

Building on this foundation, current efforts focus on integrating artificial intelligence (AI) to model cells, tissues, and diseases. These AI-driven insights are incorporated into the Atlas, enabling other researchers to harness this data for groundbreaking discoveries. The ultimate vision is a future where drug development is conducted entirely in silico, replacing costly and time-intensive physical experiments with computational simulations. This transformative approach could dramatically accelerate drug discovery and reduce associated costs.

Predicting proteins: AI’s role in accelerating science

AI has revolutionized the prediction of protein structures, cutting the time required from months or years to mere minutes. At the forefront of this breakthrough is AlphaFold, an AI system developed by Google DeepMind, which can accurately predict a protein’s 3D structure from its amino acid sequence. The AlphaFold Structure Database, created through a collaboration between Google DeepMind and EMBL’s European Bioinformatics Institute, part of the European Molecular Biology Laboratory, an intergovernmental research organization located on the Wellcome Genome Campus near Cambridge, UK., now hosts over 200 million protein structure predictions. This open-access resource includes proteins from the human proteome alongside 47 other organisms critical to global health and scientific research. The AlphaFold Server further extends its utility by predicting how proteins interact with a wide range of biomolecules, revolutionizing scientific research by accelerating drug discovery, uncovering disease mechanisms, combating antibiotic resistance, aiding vaccine development, and advancing enzyme engineering for biotechnology applications, showcasing its transformative potential across healthcare and environmental science.

The significance of this advancement cannot be overstated. In 2024, John Jumper and Demis Hassabis from Google DeepMind, along with David Baker of the University of Washington, were awarded the Nobel Prize in Chemistry for their roles in AlphaFold’s development. The accuracy of AlphaFold’s predictions is remarkable, with validation studies confirming nearly all predicted structures. In many cases, its predictions surpass experimental data, especially for proteins with flexible regions that often cannot be crystallized for traditional analysis.

Building on this foundation, Google DeepMind has partnered with Isomorphic Labs to release AlphaFold 3, an even more advanced system capable of predicting not only protein structures but also their interactions with DNA, RNA, and small molecules, such as ligands. This next-generation tool offers enhanced accuracy, paving the way for transformative applications in drug discovery and molecular biology.

The rise of collaborative biologic databases

The Human Protein Atlas and AlphaFold Structure Database are monumental resources, but they are only part of a rapidly growing ecosystem of biologic databases driving advancements in the life sciences. Among these, the Chan Zuckerberg Biohub, a collaboration among Stanford University, the University of California San Francisco (UCSF), and UC Berkeley, has emerged as a key player. The Biohub supports groundbreaking projects and early-career scientists at the intersection of biology and engineering, with a strong emphasis on transcriptomics and single-cell analysis.

Another transformative initiative is the Human Cell Atlas, a global consortium of over 3,600 scientists working to map every cell type in the human body. This ambitious project aims to create a comprehensive 3D atlas of human cells, enhancing our understanding of biology and disease mechanisms. To date, more than 100 million cells from over 10,000 individuals have been analyzed. Similarly, the Allen Brain Atlases, developed by the Allen Institute, provide detailed insights into brain cell types, anatomy, neuronal circuits, and gene expression, offering an invaluable resource for neuroscience research.

While these databases represent remarkable technological progress, the potential of AI in this domain remains largely untapped. Current data sets, though vast, are often noisy, insufficiently quantitative, and lack the comprehensiveness needed for AI-driven applications like modeling human cells. Despite these limitations, these resources provide invaluable preliminary predictions, which are further validated through experimental approaches. Crucially, most of these initiatives are committed to open access, ensuring that their data is freely available to the global scientific community, a key driver for innovation and collaboration.

Driving innovation in protein analysis

Recent technological breakthroughs have redefined the landscape of protein analysis, providing unprecedented tools to accelerate advancements in biopharmaceutical research. Two companies, Colorado-based SomaLogic and Uppsala, Sweden-based Olink, have developed revolutionary platforms enabling next-generation blood profiling. These cutting-edge technologies can analyze thousands of proteins from just a single drop of blood, a feat once thought impossible. Emerging within the past five years, these tools have been transformative, earning the term “next-generation blood profiling” for their ability to deliver comprehensive, high-throughput protein data.

Complementing these innovations, Antibodypedia offers a vast searchable database containing over four million research antibodies targeting more than 19,000 human proteins. This resource, encompassing approximately 200 antibodies per protein, empowers researchers with a robust toolkit to study protein function, distribution, and interactions with unmatched specificity.

Together, these advancements have significantly expanded the arsenal of tools available for protein analysis. Their impact on the biopharmaceutical industry is profound, with potential implications for both diagnostics and drug development that may surpass even the transformative effects of genomics and transcriptomics. From early disease detection to precision medicine and therapeutic discovery, these innovations promise to catalyze a new era of protein-driven breakthroughs.

Decoding disease with omics and protein profiling

The integration of various omics fields, including genomics, proteomics, metabolomics, transcriptomics, and microbiomics, among others, has provided invaluable insights into human biology. A landmark study followed 100 healthy individuals over two years, collecting biological samples every three months. Using advanced technologies like SomaLogic and Olink for proteomics, along with mass spectrometry and sequencing methods, researchers analyzed thousands of data points across multiple omics layers.

The most striking discovery was the stability of blood protein profiles, which remained unique to each individual throughout the study period. These profiles exhibited remarkable consistency, changing only in response to disease onset. This finding raises pivotal questions: What defines the uniqueness of these protein profiles, and how does disease alter them?

This research highlights the immense potential of blood protein analysis in disease diagnostics and precision medicine. Proteins in the blood provide a stable yet sensitive biomarker for monitoring health and detecting early signs of disease. Moreover, the simplicity of collecting a finger-prick blood sample to simultaneously measure up to 10,000 proteins underscores the feasibility of widespread clinical adoption for both diagnostic and therapeutic purposes.

Advancing diagnostics with protein biomarkers

The growing interest in biomarkers, many of which are proteins has transformed the field of disease detection and monitoring. Biomarkers serve as indicators of disease presence, progression, or treatment response, but their clinical application has been hindered by a critical challenge: the lack of reproducibility in diagnostic tests based on protein detection assays. Despite the identification of numerous potential biomarkers, very few make it into approved and clinically viable diagnostic tools. This highlights the urgent need for advancements in protein analysis technologies, particularly those capable of detecting minute quantities of specific proteins within complex biological samples.

Next-generation protein analysis platforms, such as those developed by SomaLogic and Olink, are poised to overcome these limitations. These technologies enable the simultaneous detection and quantification of thousands of proteins from a single assay, revolutionizing diagnostic precision and efficiency. This breakthrough not only increases the applicability of biomarkers but also paves the way for more robust and scalable diagnostic testing.

Moreover, advancements in protein analysis promise to propel precision medicine forward. With the ability to detect diseases earlier, stratify patients by specific disease characteristics, and monitor the effectiveness of treatments, these tools offer a pathway to more personalized and effective healthcare. As such, next-generation protein profiling is set to redefine diagnostics and therapeutic monitoring, addressing unmet needs in healthcare with transformative potential.

Reimagining biotherapeutics via protein science

Proteins serve as the primary targets for most pharmaceuticals, making advances in understanding their roles within disease pathways crucial for drug development. The Human Protein Atlas has become a priceless tool for researchers, providing detailed insights into drug targets and potential therapeutic interventions. By leveraging its comprehensive database, drug developers, particularly small and emerging pharma companies with limited resources, can gain critical information, such as whether a protein is widely distributed throughout the body (and thus a less ideal target) or localized to a specific disease mechanism or organ, with unprecedented speed and accuracy.

The first 20 years of the Human Protein Atlas project focused primarily on healthy cells, tissues, and organs, as well as various types of cancer cells and tumors. However, its latest iteration, Version 24, launched in October 2024, now includes extensive data on proteins associated with diverse diseases. Complementing this, the newly introduced Disease Atlas, released in November 2024, covers a wide range of indications, including cancers, cardiovascular and infectious diseases, autoimmune and neurological disorders, and more. With an emphasis on blood profiling, the Disease Atlas aims to support drug development, patient stratification, therapy monitoring, and biomarker discovery.

The future of therapeutic development lies in the integration of advanced protein engineering and AI. These technologies promise to enable the creation of highly sophisticated biopharmaceuticals tailored to specific disease mechanisms. One groundbreaking example of this potential is the development of a novel drug targeting mitochondrial dysfunction. Using AI to model the metabolic functions of mitochondria, cellular organelles responsible for generating chemical energy in the form of adenosine triphosphate (ATP), researchers identified a combination therapy (comprising l-serine, nicotinamide riboside, N-acetyl-l-cysteine, and l-carnitine tartrate) designed to boost mitochondrial performance. Initially aimed at treating obesity by increasing energy expenditure, this drug showed promise for addressing mitochondrial-related diseases, including Alzheimer’s. After completing phase I and II trials, the drug has now advanced to a phase III trial, underscoring the transformative impact of AI-driven therapeutic development.

The future of protein science

With a wealth of knowledge now available on the ~20,000 protein-coding genes, their structures, functions, and the antibodies that bind to them, the ability to model diseases and develop targeted protein therapeutics has reached unprecedented levels. Advances in high-throughput protein analysis spanning the proteome, transcriptome, and microbiome are being driven by next-generation DNA sequencing technologies, particularly barcode sequencing. These innovations continue to rapidly expand the database of protein-related information, fueling new opportunities for discovery.

As the field progresses, the ultimate goal of fully in silico drug development is drawing closer to reality. This transformative approach would enable researchers to simulate experiments and therapeutic designs entirely within digital environments, drastically reducing costs and timelines. While significant challenges remain, the pace of advancement in protein science and adjacent disciplines is extraordinary, suggesting an era of breakthrough discoveries and novel therapies on the horizon.

The trajectory of protein science reflects an exciting and transformative future, where continuous innovation could redefine how we understand, diagnose, and treat diseases.

Deploying protein science at NorthX Biologics

Founded in 2021 through the consolidation of leading pharmaceutical and biological manufacturing company Cobra Biologics and a mammalian development facility acquired from Valneva, NorthX Biologics brings together decades of expertise in the production of proteins, RNA, viral vectors, and cell therapies. This integration enables NorthX Biologics to support smaller biotech companies that require strong, reliable outsourcing partners to advance their therapeutic programs.

Today, NorthX Biologics serves the global life sciences community by specializing in the development and manufacturing of recombinant proteins for both therapeutic applications and advanced non-clinical technical uses. By harnessing synergies between technical and therapeutic proteins, the company collaborates with biopharmaceutical leaders to drive innovation and growth.

At the heart of NorthX’s mission lies its Innovation Hub, a resource providing early-stage companies with state-of-the-art laboratories, advanced equipment, and access to expert scientific guidance. This model enables clients to develop efficient, scalable, and economically viable protein manufacturing processes without requiring significant upfront investments. By partnering early and focusing on process scalability and robust analytics, NorthX Biologics facilitates a seamless transition to large-scale production. The Innovation Hub also empowers the company to explore new technologies, tailor solutions to client needs, and continuously enhance its contract development and manufacturing services.

With a commitment to flexibility, scalability, and quality, NorthX Biologics leverages its legacy expertise to meet diverse client requirements. Its phase-appropriate quality systems are adapted to ensure cost-effective manufacturing at the required quality levels. By staying ahead of technological advances and fostering long-term partnerships, NorthX Biologics supports its clients from early development stages through to commercial production, delivering solutions for both technical and therapeutic protein applications. NorthX Biologics is committed to supporting innovation in therapies and technologies.

Navigating the complexities of microbial and mammalian manufacturing

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.

This site has a rich history, including the production of Sweden’s first inactivated polio vaccine. Later, it contributed to global eradication efforts through collaborations with the World Health Organization and the Bill & Melinda Gates Foundation. In addition to its robust protein and antibody production capabilities, NorthX Biologics has demonstrated expertise in handling high-risk viruses. The Stockholm facility features high-containment, multipurpose biosafety infrastructure, enabling the safe production of drug substances for pandemic-related viruses, including the highly contagious SARS-CoV-2.

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.

Advancing the science of technical and therapeutic proteins

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.

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Lipum and NorthX Biologics – a deep dive into the collaboration and production process

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.

Read full article here.

Navigating the production of non-GMP proteins in a GMP-driven environment

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 dual landscape

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!