“We welcome Dave Smith from Akron Bio and Ola Tuvesson from NorthX Biologics to present and discuss the critical functions of CMOs and their role in managing the challenges of adapting from traditional biologics to ATMPs.”
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Sweden-based NorthX Biologics which focuses on process development and GMP manufacture of advanced biological drugs, has announced the appointments of Lotta Ljungqvist, Richard Bergström, Mathias Uhlén and Lars Backsell to its board of directors.
“These industry veterans have helped build Recipharm, one of the largest CDMOs in the world. They have coordinated national vaccine programs and built European life science industry organizations and been the CEO of GE for the Nordics. They have also built innovative biotech companies with drugs reaching patients. It is an honor to serve with them to build NorthX Biologics to new heights!” said Thomas Eldered, Chairman of NorthX Biologics.
NorthX Biologics is a Nordic and European leader in plasmid DNA production and manufactures recombinant protein on a large scale for use globally. In 2021 it was recognized as a National Innovation Hub by the Swedish Minister of Enterprise and received support from the Swedish Innovation Agency, Vinnova, to help SMEs make the transition to clinical manufacturing and eventual commercialization.
“The strengthening of the board further cements our position as a leading European biologic and ATMP manufacturer. Our new directors will allow us to tap into expertise and networks that will help us transition to manufacture cell therapies and mRNA and to further improve our current DNA and protein manufacturing processes,” said Ted Fjällman, CEO NorthX Biologics.
Richard Bergström was appointed Sweden’s vaccine coordinator during the Covid-19 epidemic. This position included securing national vaccine access and producing a national vaccine plan. Prior to this, he was Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA) and served for nine years as the Director General of LIF, the Swedish Association of the Pharmaceutical Industry.
This follows positions in Switzerland in regulatory affairs at pharmaceutical companies Roche and Novartis. He has also served on the board of the Karolinska Institute.
Lotta Ljungqvist held the position of President and CEO of GE for the Nordic Region, and from 2017 to April 2022 CEO of Cytiva’s Testa Center for BioProcess Innovation. Her focus was to bridge the gap between industry, SMEs, and academia. She serves as a board member in several organizations including AroCell, BioLamina, BioArctic, Atlas Antibodies, Genovis and Vinnova. She is also the Chair of SwedenBIO, the leading Swedish industry organization for innovative biotech companies as well as Chair of the Biotechnology Division at the Royal Swedish Academy of Engineering Sciences.
Dr Ljungqvist has been Global Head of R&D BioProcess at GE Healthcare Life Sciences and previously been responsible for the Contract Manufacturing Organization of Biovitrum AB, developing new manufacturing processes for biopharmaceuticals as well as producing material for clinical trials.
Mathias Uhlén is a serial entrepreneur and Professor in microbiology at the Royal Institute of Technology (KTH). His research has focused on protein science, antibody engineering and precision medicine. He is inventor on over 100 patents and has (co-)founded over 20 different biotech companies, some of whom have been sold to big pharma. Since 2003, he has led an international effort to systematically map the human proteome and transcriptome to create the Human Protein Atlas.
Professor Uhlén is a member of the National Academy of Engineering (NAE) in the USA, the Royal Swedish Academy of Science (KVA), the Royal Swedish Academy of Engineering Sciences (IVA) and the European Molecular Biology Organization (EMBO). He is also the President of the European Federation of Biotechnology. Between 2010-2015, he was the founding Director of the Science for Life Laboratory (SciLifeLab) which is a national center and one of the largest molecular biology research laboratories in Europe at the forefront of innovation for molecular technologies like gene sequencing and proteomics.
Lars Backsell, co-founded and built Recipharm, one of the top five global CDMOs in the pharma industry. The road to becoming one of the top pharma manufacturers in the world required organic growth and innovation, many acquisitions, and considerable market and product development experience. Between 2001 and 2007 six facilities were acquired. He held the role of Chief Executive Officer from 1995 to 2007 and served as the Chairman of the Board of Directors at Recipharm from 2008-2021. He has also held senior executive positions at Coloplast AB and Pharmacia AB.
Mr Backsell is a past member of the Board of Directors of Lund University BioScience AB, PROBI Aktiebolag and BioInvent international AB. He is a member of the Royal Swedish Academy of Engineering Sciences (IVA) and in 2014 was distinguished by the Swedish Royal Patriotic Society with the prestigious Industrial Medal for exceptional entrepreneurship.
Currently, mRNA medicines, such as vaccines, require freezers that can maintain −80 °C for large-scale handling and distribution. A new project has now started, with an aim to develop production processes for manufacturing mRNA medicines that remain stable even at 4 °C or higher. – The goal is to develop a dry vaccine, which would open up completely new opportunities for handling and distribution, says Randi Nordström, a researcher in formulation development at RISE.
The new project NucleoDry is working to build up a new infrastructure for vaccine development to contribute to creating generic solutions for development of stable mRNA vaccines and pharmaceuticals. The processes are based on freeze-drying technology that enables manufacturing for human use. The project is run by RISE together with Karolinska Institutet, the production unit Vecura at Karolinska University Hospital, and the Swedish innovation and manufacturing company NorthX Biologics.
RNA, or ribonucleic acid, is in all our cells, and different ribonucleic acids have different purposes. Messenger RNA (mRNA) serves as a messenger between the cells. The cells use the code in mRNA to produce the proteins that the body needs.
– mRNA technology like vaccines or treatments have incredible potential. We are now just at the cusp of understanding its full potential. A central aspect of how much mRNA will eventually be utilised is storage stability, so that vaccines and treatments can be easily distributed globally, says Matti Sällberg, professor at Karolinska Institutet.
NucleoDry brings together expertise spanning the entire care chain from mRNA production via formulation development to scaling of manufacturing processes for large-scale pharmaceutical production.
– Manufacturing mRNA at laboratory scale and freeze-drying biological medicines are common today. On the other hand, freeze-drying mRNA medicines while maintaining functionality places new demands on processes and is a field in its infancy. These processes need to be developed in a way that makes them scalable, safe and appropriate for large-scale manufacturing for clinical use, says Ola Tuvesson, Head of Process Development at NorthX Biologics.
Good Manufacturing Practice (GMP) describes how the pharmaceutical industry produces medicines so that the patient can be certain they have received the right product and that it is of high quality. The NucleoDry project includes delivering a plan for small-scale GMP production and a plan for large-scale GMP production of mRNA medicines. These plans will describe needs and requirements. Combined with the practical and scientific knowledge that the project will developed, NucleoDry will contribute to developing stable gene-based medicines in Sweden, for the benefit of the industry, the health and medical care system, and society.
– In addition to the research and product development questions that NucleoDry will address, we are also building a national infrastructure for mRNA vaccine development that will benefit the Swedish life science industry in developing future pharmaceuticals. With this project, we want to help bridge the gap between research and clinical studies. This, in turn, will increase Sweden’s competitiveness internationally within development and manufacture of gene-based pharmaceuticals, says Randi Nordström, RISE.
Nordic Life Science Days (NLSD) is the largest Nordic partnering conference dedicated to the life science industry. The event attracts leading decision makers from biotech, pharma and med tech, as well as finance, research, policy and regulatory authorities.
The world tour is back! With more ’world leading’ activities within ATMP, highlighting and discussing the partnerships, infrastructures and competences critical to successes in our field.