Category: News

Conference “Advanced Biologics in Matfors and Beyond” at NorthX Bio went to a big success!

During a two day conference, a number of key stakeholders from the Swedish and Danish ecosystem visited the Matfors site of NorthX Biologics. The highlight of the tour being the walk about in our GMP licenced facility for ATMP manufacturing as well as the brand new innovation area, delegates also valued the discussions as such. How important it is not least for the government to know we have such capacity on Swedish territory. Yet, from a business perspective of NorthX, the importance to reach beyond the Nordics to showcase how biotechs can use this capacity.  

As the conference was such a success, with a waiting list for those that we could not fit, we are already planning for a follow up! Stay tuned.

Xintela and NorthX Biologics announce that they have signed a collaborative framework agreement to jointly accelerate the development of advanced therapeutics (ATMP) by leveraging the companies’ complementary skills and resources in ATMP development and GMP manufacturing. Projects to be initiated within the framework of the collaboration include, among other things, product and process development, quality control and increased expansion capacity for manufacturing ATMPs.

“This is a very interesting opportunity for us. Xintela has developed the unique stem cell product XSTEM, which is now in clinical development, and has strong expertise in process development and GMP manufacturing of stem cells and other ATMPs. Together with NorthX Biologics and their manufacturing capacity, we can further expand and also broaden our ATMP business”, says Evy Lundgren-Åkerlund, CEO of Xintela.
“This collaboration is another step in the right direction towards becoming a leading solution provider in the cell and gene therapy space, adding to the solid expertise NorthX has already gained from +30 years of advanced biological GMP manufacturing. I am happy to work with Xintela and look forward to our relationship going forward,” says Helena Strigård, CEO of NorthX Biologics.

The Board of NorthX Biologics (“NorthX”) has appointed Helena Strigård as the new CEO. She joins NorthX from her role as Director General for the Swedish life science industry organization, SwedenBIO. Helena will lead NorthX’s continued expansion in the development and production of advanced biologics. Ted Fjällman, current CEO of NorthX and Partner of the Company’s  main investor, Flerie Invest, will continue to support the company as a member of the Board.

NorthX has one of Northern Europe’s largest manufacturing capacities for clinical material in the forms of plasmid DNA, recombinant proteins, cell banking, and related gene therapy services. Since the takeover in October 2021, NorthX has recruited a Leadership Team, Sales Team and Board for the rapidly growing company. In addition to the GMP-certified production facility in Matfors, the Company is now establishing itself on the Karolinska University Hospital’s campus in Stockholm and is developing an innovation hub for ATMPs and advanced therapeutics in collaboration with Vinnova, the Swedish Innovation Agency.

NorthX is establishing itself as a partner of choice in the Nordics for cell and gene therapy companies that need GMP manufacturing services. Now the company wants to shift gears to become a global player with a continued strong focus on individual projects and customers, in a spirit of partnership according to the motto “Journey together”. During the first year, Ted Fjällman has had the role of interim CEO and during this time has successfully transitioned NorthX into a Company with all the necessary functions to develop internationally. With that foundation, the Company has now appointed a new CEO, Helena Strigård to continue the Company’s growth. Helena has broad experience from the Ministry of Finance and Vinnova and has taken the organization SwedenBIO through a period of rapid expansion, which saw the membership income doubled.

“NorthX has in a short time built up a broad capacity for advanced biologics. I am excited to be joining at this stage in the Company’s growth and will use all my industry know-how and global network to ensure that we succeed,” said Helena Strigård. 

“Under Helena’s leadership, SwedenBIO has taken its place on international arenas to the benefit of the entire industry. NorthX will be able to leverage that driving force to achieve international impact. As a Board we look forward to working with her in order to achieve this important goal. I would like to take this opportunity to thank Ted Fjällman for his successful efforts as interim CEO; he has laid an important foundation for continued success for NorthX and I am grateful that he continues to serve on the Company’s Board”, added Thomas Eldered, chairman of the board of NorthX.

Helena takes up her role on the 6^th October.

For further information please email NorthX at contact@nxbio.com

What: Seminar
Where: Klara Strand, Klarabergsviadukten 90, Stockholm
When: 19th October

We are organizing a seminar on “Drug development of Today and the Future” in collaboration with Abera Biosciences AB, Testa Center, RISE Research Institutes of Sweden, STUNS Life science and Business Sweden on the 19^th of October 2022. 

We are using this opportunity to invite you to participate to this event.

Be present to hear our own Eva-karin Gidlund and other eminent speakers engaged in the development of drugs talking about opportunities, problems and practical examples of the field where innovative ways of collaboration and new acquired skills were essential to surmount hurdles associated with our branch’s new demands.

The future is coming in fast, with it new challenges arise for all of us who are active in our industry. This seminar is intendent to be a platform for networking, exchange of ideas, best practices and possible solutions.

We eagerly await your participation in the seminar!

Preliminary program:

15:00 – Introduction
15:05 – Jesper Hedberg (Testa Center)
15:15 – Matti Sällberg (pre – GMP facillity)
15:25 – Eva-karin Gidlund (NorthX Biologics)
15:35 – Anna Ridderstad Wollberg (RISE)
15:45 – Coffee break
16:00 – Maria Alriksson (Abera Biosciences)
16:15 – Angelica Loskog (Lokon Pharma)
16:30 – Charlotte af Klercker & Britta Stenson (Business Sweden, followed by Q&A and discussions)
17:00 -19:00 – Mingle with snacks

Click here to register!

Human testing approaching for Swedish vaccine (lakemedelsvarlden.se) (Swedish)

Today we can announce that we are expanding within the production of cell therapy, i.a. via partnership with Alder Therapeutics and that we are expanding with a second manufacturing facility at Karolinska.

Read more via the links!

• Press release in English https://tinyurl.com/2p8f67rd
• Press release in Swedish https://tinyurl.com/4j3nx6cj

LinkedIN: https://www.linkedin.com/feed/update/urn:li:activity:6944894393241759744/

Extra good for NorthX if you like or share the LinkedIn post, thanks!

“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.”

LinkedIn: https://www.linkedin.com/feed/update/urn:li:activity:6936961483540938752

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.