HemaCare has just announced the publication of their latest article in the popular stem cell industry periodical BioInformant.  The article focuses on the need for healthy donor starting material to keep up with growing demands in the cell and gene therapy industry.
New medicines based on living cells are showing enormous promise in clinical trials, and more recently, as approved therapies in patients. This success has encouraged pharmaceutical companies to fill clinical pipelines with the next generation of CAR-T therapies, monoclonal antibodies to treat cancer, or stem cell treatments targeting damaged and diseased tissue. Meanwhile, government regulatory agencies are devising new approval pathways to help these innovative medicines reach the patients who need them more efficiently. The challenge with all this positive energy is that cells can’t simply be manufactured on demand. They must be sourced from donors, and hospital and cell collection center infrastructure are currently struggling to keep up with increased demand.
Human donors are the source of the biological starting materials that make these medicines possible. Allogeneic therapies are based on healthy donor materials, both for process development and manufacturing. What many people fail to consider is that autologous therapies rely on donations from healthy donors to a nearly equivalent degree.
Process development, the art of finding optimal methods by which to manufacture and test a product, requires healthy donor material. Patient donors impacted by their disease generally have a very different physiological profile compared to healthy donors. Therapeutic target cells may be low in number or display abnormal or unsatisfactory function. Cell subtype profiles are often skewed compared to material sourced from healthy donors. Because it is often difficult for patients to generate sufficient quantities of healthy cells even for their own treatment, healthy donor cells must be used to test processing methods and the performance of quality control assays.
Access to reliable donors is another critical consideration for cell and gene therapy manufacturers. Meeting appropriate screening criteria, and having sufficient quantities of cell therapy starting material on hand to meet ongoing clinical trial or manufacturing needs necessitates access to a large, diverse, and reliable donor network.
The need for consistent, high-quality healthy donor starting material will only grow in the coming years. Researchers and manufacturers should have a blueprint in place from the start for how they plan to fill their starting material requirements. For more information on HemaCare starting material supplies, please visit our website.
- Taylor B., and Clarke D. Why is Healthy Donor Tissue So Important for Cell and Gene Therapies? BioInformant. June 2019.