National cluster to drive commercialisation, competence development and production
In March 2023 the Swedish Government Office (Ministry of Climate and Enterprise) announced 80 million SEK ($7.7 million USD) will be given to the Swedish Agency for Innovation Systems (Vinnova) to establish a national innovation cluster for commercialisation, competence development and production capacity for ATMP in Sweden. The committment formalises Sweden’s national ambition to be ’leading in ATMP by 2030’ with the government quoting the ATMP2030 vision in their decision.
The development of advanced therapy drugs is revolutionizing health and the healthcare system’s ability to treat serious illnesses, a market with strong international growth. The ATMP Innovation Cluster is intended to strengthen Sweden’s position in clinical trials and competence development in this field, accelerating new advanced therapies to patients. The ATMP Innovation cluster will function as a national infrastructure and competence node to develop new ATMPs and related technologies from Swedish universities, colleges and healthcare, as well as to accelerate the growth of new companies and provide commercialization support to small, medium and large companies.
The announcement stirs hope in Swedish researchers and small companies developing ATMPs who have been building the bridge as they walk on it. Angelica Loskog, adjunct Professor at Uppsala University and CEO of Lokon Pharma AB says, “the ATMP innovation cluster is a great initiative to support the research and biotech community with tools and means to undertake clinical grade manufacturing of their novel ATMPs and subsequently start clinical trials. National facilities and clustered knowhow is fundamental for ATMP developers to get to know their product and manufacturing processes.”,
Though Angelica offers a cautionary tale “however, with the ambition of the Swedish government to be ‘leading in ATMP by 2030’ this initiative must be accompanied by dedicated funding for teams working in the ATMP field to ensure competitive, first class projects will be supported and further dedicated funding to the hospitals and their pharmacies to be educated, to prepare facilities and medical/pharmaceutical teams to store, handle and distribute these types of advanced medicinal products.”
Lilian Walther Jallow, founder of BOOST Pharma, an ATMP company based on Swedish research but registered in Denmark under the support of the Novo Nordisk Bio Innovation Hub, says, ”This initiative would facilitate immensely the translation of Swedish academic ATMP research, assist in generation of new companies and support small biotechs that are currently struggling in a landscape that is hard to navigate. To put Sweden on the international ATMP map, we need to understand where the bottlenecks are. This gives us a unique possibility to bring more promising drug candidates to the patients, instead of them getting struck in translation, and for small companies to be able to stay in Sweden instead of finding better opportunities abroad.”
Elias Uhlin worked as a Lead Scientist with the Advance team at CCRM 2020-2022 and now project manages the development of the ATMP pre-GMP facility at Lund University. ”This investment signifies Sweden rising to the occasion and qualifying for the big leagues. To predict what this investment will signify, we don’t have to solely rely on abstract visions, a simple glance at initiatives like CCRM and Catapult shows the ability of such centers to become self-sustaining whilst creating a surge in industry growth and generating tax revenues more than covering the initial investments. We need to ensure these investments do manifest in physical form and help mold it into the effective actor we need to boost us closer to the vision of making Sweden a leader in ATMP by 2030.”
Establishment of a CCRM hub to support Nordic ATMP development and commercialisation has been a hot topic lately and of interest since 2017, following the Research Institutets of Sweden (RISE) lead mapping of the Swedish ATMP landscape with a focus on the industry and its needs. In 2020 the report ’A national infrastructure for development, manufacturing and commercialisation of advanced therapy medicinal products’ was published by RISE. In the report Swedish companies Cytiva, AstraZeneca, CombiGene and Verigraft supported the need for a Swedish infrastructure that provides researchers and companies with local access to scalable and flexible ATMP process development solutions, increased GMP manufacturing capacities, logistics and clinical trials infrastructures.
The new infrastructure will be designed to be complementary to activities conducted at existing Innovation Hubs, The Cytiva Testa Center (biologics process development) and NorthX Biologics Innovation Hub (industrial scale advanced medicines manufacture). These hubs and the new ATMP cluster are expected to cooperate, not duplicate, there are exciting synergies to be made from the competencies of these existing hubs with that of the new stakeholders to be brought into the National ATMP Cluster.
How a CCRM Nordic and the existing infrastructures will combine their strengths offers great synergy for a complex field with a diversity of drug platforms and challenges. Angelica notes, ”the diversity of product types (various gene vehicles and cell types) that do not behave the same during either manufacture nor clinical trials makes ATMP development challenging. Understanding your product will support your discussions with regulatory bodies as both trial and market approvals will depend on customized processes and testing plans.” Diverse need requires diverse support, plenty of opportunity for all.
Another welcome mention in the governments decision was the collaboration structure, first out the gate, of the national network ATMP Sweden. Established by the stakeholder networks of the Vinnova-funded initiatives CAMP, Swelife-ATMP and ATMP2030 and with 10 current national ATMP projects under way in Sweden, the ATMP Sweden network is more essential than ever and looks forward to playing an important role in the engagement of ATMP active Swedish companies, universities, colleges, regions and authorities to the ATMP Innovation Cluster. The Center for Commercialization of Regenerative Medicine (CCRM) in Canada and the Cell and Gene Therapy Catapult in the UK were also mentioned as examples of International cooperation.
To establish the National ATMP Cluster, Vinnova will receive 25 million SEK for budget year 2023, and 55 million SEK for 2024. By 1 June 2024 at the latest, Vinnova must submit a partial report of the assignment to The Government Office (Ministry of Climate and Enterprise) including a status report for the start-up phase and proposal for an organizational model, financing plan and orientation for the ATMP Cluster. Vinnova must no later than 30 September 2025 submit a final report of the assignment containing an evaluation of the assignment as a whole and the partial report must contain a preliminary evaluation.
The National ATMP cluster decision contributes to the Swedish governments national strategy for life science (N2019/03157) and export and investment strategy (UD2019/19211) that Sweden must be positioned and marketed as a first choice for global players in terms of establishments, investments and research and innovation collaborations within the life science sector. The “A roadmap for precision medicine” developed in 2022 by the government’s Collaborative group Health & life science promoted an innovation cluster for advanced therapies to drive Sweden’s innovation capacity and domestic production.
The Cytiva/Testa Center in Uppsala, have since 2016 run as a non-profit company to create growth in biologics manufacturing by bridging the gap from discovery to industrialization. Their non-GMP, production-like facility offers process development and validation support in the adaptation from bench to industrial scale but also hands on and theoretical education in biologics production. While ATMPs are yet to be produced in this facility they do have a Biosafety Level 2 lab where the Swedish company Ziccum are scaling their ambient drying technology for virus based vaccines.
The NorthX Biologics Innovation Hub was initiated from a government announcement in 2021 for Vinnova and the biologics manufacturer NorthX Biologics to establish an innovation hub for the large scale production of advanced medicines including vaccines and cell- and gene therapy medicines. The Matfors site of NorthX Biologics has a long history in pharmaceutical manufacture and since 1998 has established a reputation in high quality process development, manufacturing and fill/finish services for HQ plasmid DNA used as a start material for gene therapy manufacture. The nearly 7000m2 facility employs over 120 highly qualified staff for industrial scale GMP and HQ manufacture, including extensive in house analytics.