HemaCare scientists have just published a white paper on a new raw material sourcing paradigm that they hope will transform the industry.
The publication centers on dedicated donors; recallable donors who are reserved to specific research programs. The basic premise is that clients will be able to reserve self-identified recallable donors who possess physiological or demographic traits deemed beneficial to a particular research program.
As the new white paper describes in detail, the benefits of the dedicated donor approach are significant. In a world where cell and gene-based therapies are emerging as a powerful new medical tool, successful commercialization of these therapies is paramount to their success. Pharmaceutical developers acknowledge that there are still significant challenges to achieving this goal.
One of the key hurdles facing the industry is how to consistently source the donor-dependent raw materials needed to scale up from clinical trial level production to global commercialization. Another critical concern is variability—unlike manufactured materials, cellular raw materials come from human donors, so variability is built in from the start. This increases the risk of failed manufacturing runs, or worse, variable downstream product efficacy.
Using dedicated donors potentially solves both issues at once. Dedicated donors are usually chosen because they have some trait-whether high target cell yields, a rare tissue type, or a specific demographic--which makes their collected cells particularly valuable. Cell therapy developers can leverage dedicated donors to mitigate variability issues, collecting and expanding raw materials from the same donor multiple times. The authors demonstrate that this approach consistently lowers collection-to-collection variability. Repeat collections result in consistent genetic composition, as well as consistent WBC yields and cellular composition profiles.
Dedicated Donors Can Be Used to Leverage Consistent T cell Profiles. T cell subset ratios are observed across five collections from the same donor. Values are reported as the percentage of T cells per total WBC yield. Representative data from a single donor.
The outcome is that developers gain long-term access to program-specific or otherwise beneficial physiological and demographic traits, mitigating sourcing challenges. At the same time, cell therapies would become more consistent overall, and patients can be assured access to multiple identical treatment doses.
Establishing a network of reliable, recallable donors takes time and hard work. HemaCare’s white paper recognizes the need for large, diverse donor networks to match patient diversity. The dedicated donor model takes that precept an important step forward. Through careful donor management and sustained outreach, the company has developed the industry’s largest recallable donor network. Leveraging that network to meet program-specific raw material sourcing requirements helps provide a smooth transition from clinical trial to commercialization, while lowering both cost and overall risk.
High-quality raw materials are the foundation of successful cell therapies. To learn more about HemaCare’s new dedicated donor program, read the full white paper here.
- Taylor B., and Basheer W. A Reliable Donor Network is the Foundation for Development of Successful Cell-Based Therapies. Nov 2020.