Serum-Free Cell Culture Media & Components for Cell Therapy

Regulatory-Friendly Maintenance and Expansion of Stem Cells and Primary Cells for Applications in Clinical Cell Therapy

Cell therapy involving therapeutic engraftment of pluripotent, multipotent, or unipotent cells for tissue repair and regeneration is a rapidly maturing field. Like all cultured eukaryotic cells, the stem cells, progenitor cells, and mature isolated primary cells used in cell-therapy research and clinical applications must be maintained in media supplemented with critical extracellular proteins like transferrin for iron management, insulin for nutrient uptake, and albumin to support optimal cellular health and growth. Stem cells also need leukemia inhibitory factor (LIF), a cytokine that inhibits differentiation and enhances the cells’ capacity for self-renewal.

Regardless of cell type or origin, clinical and commercial production of cells for therapeutic applications must be scalable and meet rigorous cGMP and regulatory standards for manufacturing quality, safety, performance, consistency, and stability. The undefined and variable composition of traditional cell-culture supplements like human serum, serum albumin (BSA or HSA), fetal bovine serum (FBS), and platelet lysates introduce potential challenges for safety, supply, scalability, and regulatory compliance.

InVitria offers fully recombinant, fully human protein supplements for regulatory-friendly, serum-reduced or serum-free culture of stem cells, isolated primary cells, and more. All products are manufactured biosynthetically in the USA, 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:

• Reduce or eliminate the introduction of adventitious pathogenic agents  associated with using serum, serum proteins or other animal-derived components. These adventitious agents include viral RNA and DNA, prion proteins, and undefined antigenic molecules.
• Provide better, more consistent, more scalable cell expansion and performance in culture, and more dependable manufacturing yield, product validation, and clinical safety of downstream clinical products.
• Eliminate concerns about the fluctuating global serum supply chain and limitations on availability of human or bovine serum, or their component proteins.

InVitria Products for Cell Therapy Applications Include:

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

• LIF to replace the need for feeder cells in stem cell culture.
• Cellastim S recombinant human albumin to replace HSA, BSA, or purified human albumin in cell culture.
• Exbumin excipient-grade recombinant human albumin for storage formulations to maintain cell viability following cryogenic preservation.
• Optiferrin recombinant human transferrin for managing iron in serum-free or serum-reduced culture applications.
• Insulin-transferrin supplements provide a convenient liquid supplement containing rh-insulin, rh-transferrin, and selenium, with or without ethanolamine and rh-albumin.

The chart below describes the InVitria products that are recommended for use with most cultured eukaryotic cell types used in cell therapy, including:

• Mesenchymal stem cells from cord blood, bone marrow, or other tissues
• Hematopoietic stem cells
• Induced pluripotent stem cells (iPSCs)
• Embryonic stem cells (ESCs)
• Isolated primary T-lymphocytes, including CAR-T cells
• Primary cell isolation and passage

At a Glance: InVitria Products and Services for Cell Therapy Applications: