In the intricate realm of mRNA therapeutics manufacturing, the meticulous selection of raw materials plays a pivotal role in ensuring the safety, efficacy, and ethical integrity of the final product. One crucial consideration in this process is the sourcing of animal origin-free raw materials—a practice that not only aligns with regulatory requirements but also safeguards the integrity of mRNA-based therapies. Let’s delve into the significance of prioritizing animal-origin-free raw materials in the manufacturing of mRNA therapeutics.
Understanding Animal-Origin-Free Raw Materials
In the context of mRNA therapeutics manufacturing, animal origin-free raw materials refer to ingredients and components sourced from non-animal origins. From cell culture media and growth factors to purification reagents and stabilizers, these raw materials form the foundation of the manufacturing process, influencing the quality, safety, and efficacy of mRNA-based therapies.
In fact, the International Society for Cell Therapy (ISCT) guidance document, ISCT Animal-Free Origin Survey Results-Summary, defines animal origin-free (AOF) products as those that do not contain or use any primary or secondary raw materials derived from animal tissue or body fluid during manufacturing.
Why It Matters
- Safety and Purity: Animal-origin-free raw materials minimize the risk of contamination by transmissible agents and unknown pathogens, ensuring the safety and purity of mRNA therapeutics for patients.
- Ethical Considerations: By opting for animal-origin-free raw materials, manufacturers uphold ethical standards and promote the humane treatment of animals, aligning with societal expectations and regulatory guidelines.
- Regulatory Compliance: Ensuring the use of animal origin-free raw materials facilitates regulatory compliance, streamlining the approval process for mRNA therapeutics and enhancing market access.
- Consistency and Reliability: Animal origin-free raw materials contribute to the consistency and reliability of manufacturing processes, reducing batch-to-batch variability, and ensuring uniform product quality.
- Traceability and Transparency: By utilizing animal-origin-free raw materials, manufacturers establish traceability and transparency throughout the supply chain, enhancing product quality control and risk management.
Our Commitment to Animal Origin-Free Raw Materials
At Areterna LLC (part of Synthgene Biotechnology), we recognize the paramount importance of sourcing animal-origin-free raw materials in mRNA therapeutics manufacturing. As pioneers in the field, we are dedicated to partnering with suppliers who share our commitment to ethical sourcing practices and stringent quality standards. Through rigorous testing, validation, and collaboration, we ensure that every raw material used in our manufacturing processes meets the highest criteria for safety, efficacy, and ethical integrity.
Summary
In conclusion, using process materials that are animal-origin-free is a crucial biopharmaceutical requirement to limit the risk of allergic reactions and viral contamination. As an mRNA technology company and supplier of mRNA raw materials for biopharma and cell & gene therapy projects, we enforce AOF for our mRNA capping analogs, enzymes, NTPs, and modified NTPs from our master cell banks to the release of our materials.
As we continue to advance in this field, let us reaffirm our commitment to ethical sourcing practices and the pursuit of excellence in mRNA therapeutics manufacturing.
References:
- ISCT guidance document “ISCT Animal-Free Origin Survey Results-Summary”
- Note for guidance on minimizing the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMEA 410/01 Rev 2 Oct 2003.) adopted by the Committee for Propietary Medicinal Products (CPMP) and by the Committee for Veterinary Medicinal products (CVMP)
- Regulation (EC) 1774/2002, Annex VIII, Chapert IV, A, 3(a)(ii).
- FDA 9CFR 94.18.