GMP Cells

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.

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GMP Cell Capabilities

Beginning in 2020, HemaCare will be the first commercial provider of GMP-compliant human primary cells isolated from leukopaks collected onsite. HemaCare leverages its expertise to provide GMP-compliant cells available for your specific research and clinical needs.

HemaCare’s GMP capabilities:

  • Leukopak and Bone Marrow Aspirate collections
  • Cell processing and isolation within a clean room environment (T cells, NK cells, etc.)
  • Cryopreservation and storage
  • Customization of collection and services to meet protocol specifications
  • Technology transfer of client-specific protocols for GMP

For more information contact us.

GMP Cell Quality

Every aspect of HemaCare’s operation is defined by SOPs, which is controlled by a stringent quality system. As a result, HemaCare provides consistent cell collection, processing, and isolation leading to the highest possible quality products for each unique human donation. In addition, HemaCare has successfully passed customer audits as well as audits by the FDA, State of California, AABB, and other regulatory authorities. Please view our licensure and accreditation.

Research Use vs GMP

HemaCare research use only products meet mandated quality and regulatory standards that promote safety, consistency, high quality, and reliability in the process of non-clinical and laboratory testing.

HemaCare GMP-compliant cellular products intended for further manufacturing and clinical use follow a more stringent and complex quality control system that requires additional quality standard operating procedure documentation covering facilities, equipment, production, packaging and labeling, and process control. The primary differences between the two intended uses are: (1) GMP qualification requires comprehensive documentation of employee training, material traceability, and equipment logs (2) comprehensive employee training programs and competency assessments (3) additional quality performance testing and (4) monitoring of quality indicators. Implementing standardized procedures and formal quality systems result in reducing variability and risk, leading to more consistent quality and reproducibility supporting the advancement of cell and gene therapies.