Alternatives to Serum and Serum Proteins for Immunotherapy Applications

Human T-cells for Autologous and Allogeneic Immunotherapy: Regulatory-Friendly Maintenance, Expansion, and Subset Enrichment

A number of promising anti-cancer immunotherapies based on adoptive T-cell transfer (ACT) are currently in development. Various approaches under active investigation include chimeric antigen receptor (CAR) T-cells, T-cell receptor (TCR) T-cells, and tumor-infiltrating lymphocytes (TILs). To date, two autologous CAR T cell immunotherapies have been approved by the FDA, tisagenlecleucel (KYMRIA) for pediatric B-cell precursor acute lymphoblastic leukemia and axicabtagene ciloleucel (YESCARTA) for adults with diffuse large B-cell lymphoma. Several other ACT immunotherapies are currently in active development to treat a wide range of cancers including non-Hodgkin’s lymphoma, acute myeloid leukemia, neuroblastoma, and other solid tumors of the brain and central nervous system.

Oftentimes the creation of immunotherapeutic T-cells involves the isolation of human T-cells from the blood of the patient being treated, followed by genetic modification, in vitro expansion, and autologous re-engraftment. To ensure patient safety, this process is subject to rigorous cGMP and regulatory standards for manufacturing quality, safety, performance, consistency, and efficiency. The T-cells used in cell-therapy research and clinical applications must be maintained in media supplemented with critical extracellular proteins to support optimal cellular health and growth. In standard T lymphocyte cell culture, these needs are typically met by supplementation with human serum albumin (HSA) and human serum, but these supplements are undefined and variable in composition, with the potential to introduce harmful pathogens to the already compromised patient in a clinical setting.

InVitria offers fully recombinant, fully human protein supplements and chemically defined media for regulatory-friendly, serum-reduced or serum-free culture and expansion of T-cells. All products are manufactured biosynthetically in the US, using recombinant DNA technology in an animal-free host, in an ISO 9001:2015 certified facility. These products are suitable for RUO and cGMP uses and enable the reduction or elimination of serum, serum-purified proteins, and serum-derived contaminants from cell culture media at any scale.

InVitria’s Products Supporting Emerging T Lymphocyte Immunotherapy Programs:

• Reduce inconsistencies associated with expansion of T lymphocytes in human serum.
• Provide a reliable supply chain that human and animal products cannot support.

Provide better, more consistent, more scalable cell expansion and performance in culture, and more dependable yield, product validation, and clinical safety of downstream clinical products. InVitria products for T-cell immunotherapy research and clinical applications include:

Animal-Free, Serum-Free Cell Culture Components and Supplements:

• Cellastim S recombinant human albumin to replace purified human albumin in cell culture.
• Exbumin excipient-grade recombinant human albumin for cell health during cryogenic preservation.
• Optiferrin recombinant human transferrin for managing iron in serum-free or serum-reduced culture applications.
• Insulin-transferrin supplements provide supplemental rh-insulin, rh-transferrin, and selenium, with or without ethanolamine and rh-albumin for serum-free or serum-reduced culture applications.

At a Glance: InVitria Products for T-Cell Immunotherapy Applications

*All protein components included in InVitria’s media products are fully human in sequence, fully recombinant, and are expressed in a non-animal host. All processing and packaging steps are fully free of animal components and are produced in the US, using cGMP standards in an ISO 9001:2015 certified facility.