Updates on FBS and HPL usage regulations

News March 10, 2025

As the field of cell and gene therapy advances, regulatory agencies are tightening the guidelines surrounding the use of fetal bovine serum (FBS) and human platelet lysate (HPL). Agencies such as the FDA and EMA are currently emphasizing the use of materials that are free from animal or human sources. Their focus is on improving the safety, consistency, and reproducibility of cell therapy products.

 

CellCor™ MSC CD AOF supports the transition to cell culture
CellCor™ MSC CD AOF supports the transition to cell culture

Regulations on FBS and HPL usage

FDA – CMC guidelines for human gene therapy (2020)

Materials of animal origin can introduce unintended agents. This leads to lot-to-lot variations, impacting product consistency. Consider using non-animal-derived reagents (e.g., serum-free media or recombinant proteases). If serum is used, it must be gamma-irradiated to reduce the risk of contamination. 

ICH Q5A(R2) – Virus safety evaluation (2024)

Emphasizes minimizing the use of materials derived from humans and animals to reduce the risk of viral contamination. It is recommended to avoid using human serum, bovine serum, or porcine trypsin in manufacturing processes.

EMA – Non-clinical/clinical quality requirements for cell therapy (Draft, 2019)

It is recommended to avoid animal-derived reagents and opt instead for non-animal-derived reagents with defined components. This helps minimize unexpected agents, reducing the need for additional testing. 

EMA – Guidelines for human cell-based medicinal products (2008)

Encourages the use of synthetic substitutes for serum whenever possible. If bovine serum is used, gamma-irradiated serum or synthetic media should be considered for use.

The transition to CD and AOF culture media

Regulatory push is not only toward adopting Xeno-Free solutions but also supporting materials that are “chemically defined” (CD) and “animal-origin-free” (AOF) for safer and more consistent manufacturing processes.

  • Chemically defined (CD) media: Provides better reproducibility and regulatory compliance by using components with fully defined ingredients. 
  • Animal-origin-free (AOF) media: Eliminates the risk of contamination from animal-derived substances, enhancing the safety of the product.

To meet the highest safety and quality standards in cell and gene therapy, the transition to CD/AOF materials is no longer optional but a necessity. 

Are you ready for the transition in cell culture? 

Culturing cells in CD/AOF media aligns with the new international standards to ensure safety and compliance in research and production. However, with so many CD/AOF media products available, which one is the most efficient? Xcell Therapeutics specializes in the production of cell culture media with CellCor™ MSC CD AOF, which fully meets the rigorous requirements for research. The CellCor™ MSC CD AOF culture media will help researchers and biotech companies adapt more easily to this transition.

Biogroup Vietnam is always ready to support you in adapting to increasingly stringent international regulations. Contact us for consultation on products and solutions for cell culture transition.

 

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Appendix

Market trends after new regulations for cell or gene therapy development (Source: Xcell Therapeutics)
Market trends after new regulations for cell or gene therapy development (Source: Xcell Therapeutics)