As the number of cell and gene therapies in development increases, so does the demand for cell-based starting material. When the sourcing of the starting material relies on human donors, it is critical to have an extensive donor network with consistent collection and stringent processes in place.
Patient-sourced disease state material is limited and highly compromised by the patient’s health. By contrast, healthy donor material is more consistently available, a better source for target cells, and a key to planning for successful commercialization of cell-based products.
Whether an allogeneic or autologous therapy, having access to healthy donor material is essential throughout the development process – during discovery research, preclinical testing, and into the clinic. Donor cells are necessary for establishing robust and well-characterized methods of production, carrying out comparability runs, and developing biologically-relevant assays for quality control testing. Because the source material is coming from healthy donors, it is easier to optimize therapeutic cell yield, reduce variability, and minimize manufacturing delays.
Donor accessibility, especially access to reliable and recallable donors, is pivotal to the cell-based process, product development, and clinical success. Find the cellular material you need to make your cell therapy program a success through HemaCare, a Charles River Company. Offering the largest diverse pool of reliable donors, HemaCare can support you with consistent, high-quality starting material as you move your different drug candidates from discovery and preclinical research to clinical trials and commercialization.