A challenge exists in the biotech industry for allogeneic cell therapy developers. These one-to-many therapies rely on consistent, high-quality source material from donors with specific attributes. But as the demand for a therapy grows, how can allogeneic cell therapy developers scale their donor pool to meet that demand while not sacrificing quality?
Some industry experts say dedicated donor pools—sometimes called “super donors”—are the answer. A dedicated donor pool is just as it sounds—a small subset of people who have the desired attributes for a therapy that is willing to donate repeatedly.
While this may be an ideal state, it is not likely to be a long-term solution. Companies that rely heavily on a dedicated donor pool introduce risk into their business strategy.
One simple reason is that life circumstances change.As time goes by, people experience life events that impact their ability to donate. For example, they may relocate, get sick, or make choices that make them ineligible to donate.
Additionally, donors may stop responding. If asked to donate continually, donors may get tired. Allogeneic therapy developers will have to start over again if they have not replenished their donor pool.
While a dedicated donor pool is not the answer to the supply challenge, allogeneic cell therapy developers can take steps that will allow them to scale.
- Inquire about a supplier’s donor registry depth and breadth. For example, Be The Match BioTherapies® supplies donors using Be The Match Registry®. Because of its sheer size of more than 22 million potential donors, the team can identify additional donors that meet a company’s requirements by conducting concurrent screening. This approach enables constant replenishment of the pre-screened donor pool.
- The diversity of a supplier’s donor pool is also essential. For therapies with indications predominantly found in specific populations, allogeneic cell therapy developers will need to identify donors who have likely come from that same population. It’s vital to use the most diverse registry available, one which adds donors on an annual basis. This donor pool breadth can be a critical factor for companies.
- Understand how a supplier’s donor compensation policy could impact the ability to market a product. To help with reliability, some companies compensate donors for their time—a practice that can introduce long-term risk. That risk is exceptionally high for companies that plan to market their product in multiple countries.
- Globally, regulations regarding compensation differ by country and can be unclear. However, some significant markets prohibit or strongly discourage donor compensation. These include the European Union, Canada, and Japan.
- If a cell therapy developer uses cells from a compensated donor to develop a drug therapy, there is no guarantee that the therapy can be used worldwide. By using voluntary, unpaid donors, a registry ensures the broadest possible use of the eventual therapies.
- Additionally, donors may be less forthcoming with health histories if compensation could be at risk. These omissions could be very detrimental to a company if it is discovered years down the line that cells are unusable because a donor did not disclose a health event at the time of donation.
- Start as broadly as possible with donor requirements. The donor funnel gets narrower and narrower with every requirement a company puts in place. That makes it less likely that a set of donors will meet all of the requirements.
- To make the donor selection process more efficient, allogeneic cell therapy developers should weigh how much specific factors may or may not play into the manufacturing of the therapy. Then they can identify the absolute needs, those that would be nice to have, and those factors that will not matter.
- Starting the donor selection process with too many requirements could exclude some donors unnecessarily.
- Make the donor screening process as efficient as possible. Set up the screening activities in a way that doesn’t leave too much time between steps when confirming that a donor meets all requirements. If a donor waits too long to hear their results, it increases the risk of losing interest or engaging in behaviors that would make them ineligible to donate.
While relying on a dedicated donor pool is not the answer to scalability, taking these steps can help allogeneic cell therapy developers set their companies up for future success.
About the author
Abby McDonald, Ph.D., Manager, Solutions Development, Be The Match BioTherapies
Abby McDonald, Ph.D., is the Manager of Solutions Development for Be The Match BioTherapies. She and her team are responsible for collaborating with clients to clarify product requirements and specifications, communicating with internal stakeholders to ensure timely design and delivery of proposed solutions, and identifying and improving necessary system process changes to deliver the product to the customer.
Abby joined the organization in 2013 as an Immunogenetic Specialist functioning as an internal and external HLA expert, leading cross-departmental research projects, and participating in registry data quality control. She holds her Ph.D. in Molecular Biology and Genetics from the University of Minnesota.