Utilizing 40 years of collection experience, HemaCare provides GMP-compliant cells that meet all current FDA and European Medicines Agency (EMA) guidelines for quality biological products.
When developing a cell-based therapy, variability of living cells can negatively impact the efficacy of a medical treatment. It is critical that companies optimize production workflows from the beginning to ensure an effective and reliable product. Because the number of healthy cells in starting material directly impacts the efficacy of the final product, the need for high-quality starting material is critical to success. HemaCare understands the product needs and regulatory requirements customers face during the development of autologous and allogeneic cell-based therapies.
By leveraging its FDA-registered tissue collection facility, highly-characterized donor pool, and regulatory expertise, customers receive high-quality, consistent GMP-compliant cellular material that forms the basis of their project.
HemaCare has provided leukapheresis process development material for 100% of the current FDA-approved immunocellular therapies. Leukapheresis collections can be customized to meet process development needs for testing, engineering, and comparability runs. HemaCare offers fresh, cryopreserved, and split leukapheresis collections that can be shipped to multiple sites to support tech transfer comparability projects. HemaCare’s expertise in apheresis-derived cellular materials underpins the success of live drugs from preclinical research through phase III clinical trials.