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How Regulatory Bodies Are Driving the Shift to Animal-Origin-Free Solutions in Cell Therapy and Vaccine Development

Published on 29 January 2025

Enhancing Safety, Consistency, and Ethics in Biomanufacturing Through Regulatory Guidance

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Exterior view of the FDA headquarters building, showcasing the official FDA sign, representing regulatory oversight in ensuring safety and compliance in biomanufacturing

Global regulatory agencies—including the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), WHO (World Health Organization), and PMDA (Pharmaceuticals and Medical Devices Agency of Japan)—are driving the shift to animal-origin-free (AOF) solutions in cell therapy and vaccine manufacturing. Their goal: to enhance product safety, standardize quality, and align with ethical considerations. Japan’s PMDA, for example, enforces some of the strictest requirements on animal-origin components.

Addressing Safety Concerns with Animal-Origin Components

One of the primary motivations for regulatory guidance on AOF solutions is the inherent risks associated with animal-derived materials like fetal bovine serum (FBS), human/bovine albumin, human serum, human AB serum, and human/bovine transferrin. Additionally, the use of animal components such as serum necessitates substantial additional testing requirements.

A regulatory lead at a major biopharma, who also consults for the Bill and Melinda Gates Foundation program, provided off-the-record guidance on this issue:

“Donor testing for human materials varies by region. In the EU, compliance with EMA regulations is required for tissue and blood procurement, screening, and testing—yet individual nations may impose even stricter requirements, such as malaria testing in certain countries.

Sourcing raw materials becomes complex when planning for global markets. AOF solutions simplify this process while also improving batch-to-batch consistency and eliminating donor-dependent variability.

Beyond compliance, the safety advantages of non-human-derived materials are clear.”

Key Risks of Animal-Origin Materials

  • Contamination Threats: Animal-derived materials can harbor viruses, prions, endotoxins, or other harmful contaminants, compromising the safety of cell therapies and vaccines. The FDA’s Considerations for the Use of Human- and Animal-Derived Materials underscores these risks.
  • Batch-to-Batch Variability: The inconsistency of animal-derived components leads to challenges in reproducibility and reliability during manufacturing. This variability affects final product quality and places additional strain on quality management systems.

By advocating for recombinant and chemically defined materials, regulatory bodies aim to mitigate these risks and improve the safety profile of biotherapeutic products.

Regulatory Trends in GMP Compliance

Regulatory agencies are enforcing stricter Good Manufacturing Practices (GMP) guidelines to limit the use of animal-origin materials. Key areas of focus include:

  • Adoption of Chemically Defined Materials: Reducing contamination risks and improving consistency.
  • Alignment with USP Guidelines: Encouraging recombinant, animal-free supplements as industry best practices. While USP guidelines don’t explicitly require recombinant materials, they align with global safety frameworks.

Such practices ensure that biotherapeutics meet the highest safety and quality standards, facilitating smoother regulatory approval processes.

Alignment with Regulatory Guidelines and Recommendations

Several prominent regulatory bodies have issued clear guidance on the use of animal-origin-free materials:

 

  • European Medicines Agency (EMA): The EMA’s guidelines for cell-based medicinal products stress the importance of avoiding animal-derived materials to prevent immunogenic reactions and cross-contamination. It promotes the use of chemically defined media and recombinant alternatives, aligning with international standards like ICH Q5A and Q5D.
  • U.S. Food and Drug Administration (FDA): The FDA encourages manufacturers to use recombinant materials, citing their ability to reduce contamination risks and variability. Its guidance documents, including “Considerations for the Use of Human- and Animal-Derived Materials,” outline the regulatory framework for safer, animal-origin-free biomanufacturing.
  • World Health Organization (WHO): The WHO advocates for the replacement of animal-origin materials in vaccine and biologics production to enhance safety, scalability, and accessibility. Its global health initiatives aim to minimize contamination risks and improve consistency in biomanufacturing practices.
  • Pharmaceutical and Medical Device Agency (PMDA): The PMDA’s stringent stance on animal-derived components reflects Japan’s commitment to global safety standards in biomanufacturing. It encourages the use of chemically defined and recombinant materials, reinforcing its alignment with ICH guidelines.
  • Therapeutic Goods Administration (TGA): The TGA emphasizes the elimination of animal-derived materials in biologics, vaccines, and cell therapies to ensure compliance with Australian Regulatory Guidelines for Biologicals (ARGB). It supports the adoption of animal-free technologies to improve sterility and scalability in manufacturing.
  • Health Canada: Health Canada actively promotes chemically defined and animal-origin-free materials to reduce contamination risks and ensure consistency in therapeutic manufacturing. Its regulatory framework focuses on safer alternatives to traditional animal-based products in biologics and cell-based therapies.
  • Central Drugs Standard Control Organization (CDSCO): India’s CDSCO is modernizing its biologics regulations by encouraging the use of recombinant, animal-free components in vaccines and advanced therapies. The organization aims to align with global safety standards and address contamination concerns associated with animal-derived materials.
  • National Medical Products Administration (NMPA): China’s NMPA (formerly CFDA) emphasizes the use of animal-origin-free components in biologics, monoclonal antibodies, and cell therapies to enhance product safety. It references international guidelines, such as ICH Q5A/Q5D, to guide manufacturers toward safer biomanufacturing processes.
  • Korea Ministry of Food and Drug Safety (MFDS): South Korea’s MFDS promotes animal-origin-free biomanufacturing by requiring chemically defined materials in biologics and cell-based therapies. Its alignment with international standards ensures safer production and global competitiveness.
  • International Council for Harmonisation (ICH): The International Council for Harmonisation (ICH) sets global regulatory standards through guidelines like Q5A and Q5D, advocating for the elimination of animal-derived materials in cell substrates and biologics manufacturing to reduce risks and ensure product consistency.

Incorporating these guidelines into manufacturing practices not only ensures compliance but also positions companies to meet international market expectations.

Simplifying Market Access and Licensing

Beyond contamination risks, regulatory agencies impose substantial testing requirements for animal-derived materials. The variability in donor testing requirements across different regions makes sourcing materials for global markets complex. This adds another layer of difficulty in obtaining regulatory approvals, further emphasizing the advantages of AOF solutions.

Regulatory bodies recognize that products developed with AOF materials are easier to license and market globally, especially in regions with strict restrictions on animal-derived ingredients. By adopting AOF solutions, manufacturers can:

  • Streamline Regulatory Approvals: Compliance with AOF guidelines helps companies meet international regulatory expectations more easily.
  • Expand Market Opportunities: Products that adhere to AOF standards are well-received in global markets, enhancing competitiveness.

Encouraging Scalability and Cost-Effectiveness

The transition to animal-origin-free solutions is not just about safety and ethics—it’s also about practicality. AOF materials enable manufacturers to:

  • Achieve Scalability: Chemically defined and recombinant supplements ensure consistent performance, even at large production scales.
  • Enhance Cost-Efficiency: With fewer risks of contamination and variability, AOF solutions reduce the need for extensive testing and quality control measures, saving time and resources.

The Future of Biomanufacturing: AOF as the New Standard

Regulatory agencies are setting a clear trajectory for the future of biomanufacturing: a shift to animal-origin-free solutions. Companies that proactively adopt recombinant materials will benefit from:

  • Enhanced Safety: Lower contamination risks and improved product consistency.
  • Regulatory Compliance: Alignment with evolving global guidelines.
  • Market Expansion: Easier approvals and broader international acceptance.
  • Scalability & Cost Efficiency: Streamlined production with reduced testing burdens.

The Role of InVitria in Supporting the Industry Shift

At InVitria, we are committed meet the industries growing demand for reliable solutions that help biomanufacturers transition to animal-origin-free solutions through our portfolio of recombinant, chemically defined cell culture media supplements. Our products are designed to:

  • Enhance cell growth, viability, and productivity with performance-driven solutions.
  • Ensure supply chain reliability through metric-ton capacity manufacturing.
  • Facilitate global distribution in over 40 countries.
  • Support over 300 clinical programs, reinforcing our reputation as a trusted solution provider.
  • Lower environmental impact by reducing carbon footprint through sustainable, animal-free production methods.
  • Maintain the highest quality standards with cGMP-compliant manufacturing in the USA.
  • Support regulatory compliance to streamline approval processes.
  • Improve safety and scalability for biomanufacturing operations.

As regulatory bodies continue to drive the adoption of animal-free alternatives, InVitria remains committed to supporting manufacturers with cutting-edge technologies designed to meet both current challenges and future-proof manufacturing for long-term success.

Ready to Learn More?

Discover how InVitria’s animal-origin-free solutions can help your biomanufacturing process meet regulatory expectations while improving efficiency and safety. Contact us today to explore our innovative products.

Overview of InVitria’s Product Offerings

InVitria offers a comprehensive portfolio of animal-origin free, recombinant, chemically defined solutions designed to enhance the performance and safety of biomanufacturing. Our product categories include:

Recombinant Human Serum Albumin (rHSA)

Supports cell growth, stabilization, and formulation of biologics.

  • Cellastim S® – Enhances cell culture performance and biomanufacturing scalability. (Available in 10 g, 100 g & bulk quantities)
  • Exbumin® – The first and only recombinant albumin approved as an excipient for biologics formulation. (Available in 10 g, 100 g & bulk quantities)
  • Optibumin® 20 – Ultra-pure rHSA designed for small molecule solubilization, bioconjugation, and iPSC/hESC applications. (Available in 100 mL, 1 L & bulk quantities)
  • Optibumin® 25 (in bags) – Available soon – Designed for closed-system biomanufacturing applications. (Available in 100 mL bags)

Recombinant Transferrin and Iron-Carrying Proteins

Essential for optimal cell culture performance and iron regulation.

  • Optiferrin® – Recombinant human transferrin, replacing serum-derived transferrin and iron chelators in cell culture. (Available in 1 g & 10 g & bulk quantities)
  • Lacromin®– Recombinant human lactoferrin that enhances cell expansion and protects against apoptosis. (Available in 10 g, 100 g & bulk quantities)

Recombinant Growth Factors and Cytokines

Enhances cell proliferation, differentiation, and productivity.

Chemically Defined Cell Culture Media Supplements

Optimized to improve cell viability, yield, and scalability.

  • ITS Animal-Free – A chemically defined insulin-transferrin-selenium supplement for cell culture. (Available in 10 mL, 100 mL & 10 mL x 10 & bulk quantities)
  • ITSE Animal-Free®  – A chemically defined supplement containing insulin, transferrin, selenium, and ethanolamine. (Available in 10 mL, 100 mL & 10 mL x 10 & bulk quantities)
  • ITSE+A Animal-Free – A chemically defined supplement with insulin, transferrin, selenium, ethanolamine, and ascorbic acid for enhanced antioxidant support. (Available in 10 mL, 100 mL & 10 mL x 10 & bulk quantities)
  • Lysobac®– A recombinant animal-free lysozyme supplement designed to improve bacterial cell lysis efficiency in bioprocessing. (Available in 10 g,  100 g & bulk quantities)

Serum-Free and Xeno-Free Media Components


Provides enhanced consistency, safety, and regulatory compliance

  • OptiVERO® Complete Media Kit – A defined media solution for optimizing virus production in Vero cells. (Available in 1 L kit (2 components) & bulk quantities)

Stay Ahead with InVitria’s Latest Innovations

At InVitria, we are committed to advancing biomanufacturing with cutting-edge, recombinant, and chemically defined solutions. We are continuously innovating to meet the evolving needs of the industry. Subscribe to our newsletter to be the first to know about new product releases, updates, and exclusive insights.

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Footnotes

References

  1. BioPharmaDive. (n.d.). The shift toward animal-origin-free products in biologics manufacturing. Retrieved from https://www.biopharmadive.com
  2. Cytotechnology. (n.d.). Assessing variability in fetal bovine serum for cell culture applications. Retrieved from https://link.springer.com/journal/10616
  3. European Medicines Agency. (n.d.). Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products. Retrieved from https://www.ema.europa.eu
  4. Health Canada. (n.d.). Guidance for human cell and tissue-based products. Retrieved from https://www.canada.ca/en/health-canada.html
  5. International Council for Harmonisation. (n.d.). ICH guidelines Q5A (viral safety) and Q5D (cell substrates). Retrieved from https://www.ich.org
  6. International Journal of Pharmaceutics. (n.d.). Animal-origin components and contamination in biomanufacturing. Retrieved from https://www.sciencedirect.com
  7. Korea Ministry of Food and Drug Safety. (n.d.). Guidelines for biomanufacturing and recombinant products. Retrieved from https://www.mfds.go.kr
  8. Nature Biotechnology. (n.d.). The role of recombinant proteins in biomanufacturing. Retrieved from https://www.nature.com/nbt
  9. Pharmaceuticals and Medical Devices Agency. (n.d.). Overview of regulations in Japan. Retrieved from https://www.pmda.go.jp/english
  10. Therapeutic Goods Administration. (n.d.). Australian regulatory guidelines for biologicals. Retrieved from https://www.tga.gov.au
  11. U.S. Food and Drug Administration. (n.d.). Current good manufacturing practice (cGMP) regulations (21 CFR Parts 210 and 211). Retrieved from https://www.ecfr.gov/current/title-21
  12. U.S. Food and Drug Administration. (n.d.). Guidance for industry: Cell-based products for animal and veterinary use. FDA Guidance Documents. Retrieved from https://www.fda.gov/regulatory-information/search-fda-guidance-documents
  13. U.S. Food and Drug Administration. (n.d.). Considerations for the use of human- and animal-derived materials in the manufacture of cell and gene therapy and tissue-engineered medical products. Retrieved from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-human-and-animal-derived-materials-manufacture-cell-and-gene-therapy-and-tissue
  14. World Health Organization. (n.d.). Recommendations for the production and control of vaccines. Retrieved from https://www.who.int/publications
  15. World Medical Association. (n.d.). Declaration of Helsinki: Ethical principles for medical research involving human subjects. Retrieved from https://www.wma.net

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