International lessons in building the cell and gene therapy manufacturing workforce, from Seattle and the Nordic countries.

The Nordic countries have a few things in common with the drippy, green Northwest corner of the United States. Settled partly by Scandinavian fishermen and loggers, Seattle claims to have the largest Norwegian Independence Day celebration outside of Norway, and it is home to the National Nordic Museum.

Both regions are also now building infrastructure to support one of the fastest growing areas of biopharma – cell and gene therapy. Finding the workers for these efforts is top of mind for biopharma leaders in both regions.

“It’s a global problem,” says Bo Wiinberg, Chief Business Development Officer of Novo Nordisk Foundation Cellerator, an initiative to support final development and GMP manufacturing of cell therapies for academia and industry, based in the Copenhagen area.

Seattle has faced such workforce challenges for several years. Its academic institutions helped pioneer cell therapies and companies like Bristol Myers Squibb (BMS), Sana Biotechnology and Lyell Immunopharma all have cell therapy manufacturing operations in the region.

The biotech industry has been around for decades here, whereas manufacturing is relatively newer, and so we’re just in the process of really growing that pipeline.”

“The biotech industry has been around for decades here, whereas manufacturing is relatively newer, and so we’re just in the process of really growing that pipeline,” says Marc Cummings, CEO of Trade Group Life Science Washington.

Seattle’s nascent approach to building up the cell and gene therapy workforce could provide lessons for other regions. As the Nordic countries develop the field, they are similarly looking into how to fill the employment pipeline.

 

Marc Cummings, CEO, Trade Group Life Science Washington, and Bo Wiinberg, Chief Business Development Officer, Cellerator (Photo: The BioInnovation Institute)

 

Next-generation needs

Cell and gene therapies are complex to manufacture and suffer from lack of standardization and streamlining, noted a 2023 report by life sciences firm Cytiva. The report surveyed 1250 biopharma leaders worldwide, who identified manufacturing talent for GMP-certified facilities as the most difficult skill to attract and retain.

In 2022, the U.S. government created the National Biotechnology and Biomanufacturing Initiative, including mandates to bolster the workforce.”

A 2021 report funded by the U.S. National Science Foundation found that many universities do not have biopharma manufacturing expertise, and advised industry and educational institutions to collaborate on best practices and accreditation for next-generation needs. In 2022, the U.S. government created the National Biotechnology and Biomanufacturing Initiative, including mandates to bolster the workforce.

Workforce needs will only increase as companies transition into commercialization. The U.S. Food and Drug Administration received 300 investigational new drug applications for cell and gene therapies in 2021, according to BioSpace, three-fold more than in 2012.

Industry-supported program

In the Seattle area, Shoreline Community College launched an industry-supported technical program in 2021. In one track, applicants are selected by BMS or Seagen, a Seattle-area company recently bought by Pfizer. The companies pay for a ten-week biomanufacturing certificate course and provide a paid follow-up internship. The program draws applicants from immigrant communities, people re-entering the workforce and local high schools.

“Our certificate is becoming known, so students are getting hired even at other companies where they didn’t intern,” says program leader Rachel Rawle. The program communicates with industry to adjust its offerings, including for cell and gene therapy manufacturing.

To help develop the curriculum, Rawle also tapped into the NSF Engineering Research Center for Cell Manufacturing Technologies. The National Institute for Innovation in Manufacturing Biopharmaceuticals provided grant funding.

The center partners with local life science companies to adapt to employment needs.”

Shoreline interacts with Career Connect, a public-private partnership to connect youth in the state with hands-on education programs. It also interfaces with the Center for Biotechnology Innovation & Training at the University of Washington, Bothell, which is developing certificate, four-year and master’s degree programs. The center partners with local life science companies to adapt to employment needs. Researchers can also tap into Seattle Children’s Therapeutics Cell Manufacturing Facility, which offers lab space and assistance for quality control testing and process development.

Working together

Of the Nordic countries, Sweden has the most highly-developed ecosystem for advanced therapy medical products (ATMPs) such as cell therapies, says Wiinberg.

The Swedish government supports several public-private endeavors, such as the NorthX Innovation Hub, which is expanding into cell therapy manufacturing, and the Centre for Commercialization of Regenerative Medicine (CCRM) Nordic, based on the Toronto CCRM. In a third partnership, Cytiva helps teams scale up to industrial-level production, rents equipment and provides training at its Testa Center – a model the company also brings to other countries.

The three of us work together in our communication efforts to promote our innovation hubs, including the need for skilled people.”

“The three of us work together in our communication efforts to promote our innovation hubs, including the need for skilled people,” says Janet Hoogstraate, CEO of NorthX Biologics, a contract development and manufacturing organization.

Nordic endeavors more closely linked to universities include the Karolinska ATMP center and an ATMP center at Lund University, both announced in 2023, and the Centre for Advanced Cell Therapy at Oslo University Hospital. Cellerator partners with the Novo Nordisk Foundation Center for Stem Cell Medicine, reNEW, a three-site research partnership at the University of Copenhagen, Leiden Medical University in The Netherlands and the Murdoch Children’s Research Institute in Australia.

 

Rachel Rawle, Program Leader, Shoreline Community College, and Janet Hoogstraate, CEO, NorthX Biologics (Photo: Jan Landfeldt)

 

A need for education programs

While Seattle built manufacturing capacity largely from scratch, Denmark and other Nordic countries have a longer history of biopharma manufacturing. That also means there’s a lot of competition from established players for workers, says Wiinberg.

There’s a lack of education programs in the Nordic countries specifically focused on manufacturing and process development for cell and gene therapies, he says.

It takes time to establish these certifications. It takes time to educate people. So, it’s very timely to start thinking about some of these things. In the end, it’s the universities that need to own this and drive this.”

The Novo Nordisk Foundation, which will open the Cellerator in 2027 at the Technical University of Denmark in Lyngby, is now working with a consulting agency to assess workforce needs, and engaging with educational institutions.

“It takes time to establish these certifications. It takes time to educate people. So, it’s very timely to start thinking about some of these things,” says Wiinberg. “In the end, it’s the universities that need to own this and drive this.”

 



About the author

Charlotte Schubert, Ph.D., is a Seattle-based freelance science journalist, writer and editor. She formerly served as an editor at Nature Medicine and for a cell therapy team at Seattle Children’s Research Institute.