Serum-Free T-Cell Media 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. Other ACT immunotherapies are 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.
Often times 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 or 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 supply chain reliability 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:
Pre-formulated, serum-free, chemically defined media optimized for passage and expansion of T-cell phenotypic subsets after isolation from whole blood. This regulatory-friendly media is cGMP-ready for production of patient-specific T-cell immunotherapies suitable for engraftment.
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.
OptiPEAK Media Optimization Services
InVitria offers the experience and know-how to help you supplement your media of choice with its full line of animal-free, serum-free, recombinant individual cell-culture components. Our Product Applications team is ready to help you build a serum-reduced or chemically defined medium optimized to your application.
InVitria Custom Media Formulation Services
Have specific needs or a proprietary cell type or vector? To learn more about transitioning your cell therapy production system to complete, chemically defined, serum-free media, contact us or follow the link to InVitria’s Custom Media Formulation services page
At a Glance: InVitria Products for T-Cell Immunotherapy Applications
|Name||Function||Recombinant||Human sequence||Animal Free||Blood Free||IgG Free||Available grades|
|Defined, Complete Cell-Culture Media Solutions|
|OptiPEAK T-Lymphocyte||Serum-free or serum-reduced culture of isolated T cells for maintenance and expansion of desired T-cell subsets.||✅||✅||✅||✅||✅||RUO
|Media Optimization and Custom Media Formulation Services||InVitria’s Product Application Specialists have the knowledge and experience to help you build a custom, scalable, serum-free or reduced-serum solution to meet the needs of your specific T-cell subset and expansion process.||✅||✅||✅||✅||✅||RUO
|Individual Cell Culture Components|
|Cellastim S||Animal-free, serum-free recombinant human albumin to replace HSA/BSA and FBS in serum-free or serum-reduced cell culture.||✅||✅||✅||✅||✅||cGMP|
|Exbumin||Excipient-grade, animal-free, serum-free recombinant human albumin to improve cell stability in cryogenic preservation. Exbumin is approved for use as an excipient in injectable therapeutics.||✅||✅||✅||✅||✅||cGMP|
|Optiferrin||Animal-free, serum-free recombinant human transferrin for iron nutrition and management in serum-free or serum-reduced culture applications.||✅||✅||✅||✅||✅||cGMP|
|ITS, ITSE, ITSE+A Insulin-Transferrin Supplements||Provides supplemental rh-insulin rh-transferrin, and selenium, with or without ethanolamine and rh-albumin for serum-free or serum-reduced culture applications.||✅||✅||✅||✅||✅||cGMP|
*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.