Mitigate Virus Contamination Risks for Advanced Therapies

The utilization of cell cultures and raw materials derived from animals or humans underscores the necessity for robust virus safety strategies. However, the absence of standardized downstream processes in many ATMP manufacturing methods impedes the adoption of proven virus clearance techniques. Implementing virus filtration for cell culture media and additives offers a straightforward risk mitigation approach to enhance the safety profile of ATMP manufacturing. This strategy is particularly advantageous in upstream processing for production setups reliant on high-risk materials or components that lack safer alternatives.

Key Takeways:

1. Virus Safety Importance: ATMPs face virus contamination risks similar to traditional biologics, necessitating effective safety measures due to non-standardized downstream processes.
2. Risk Mitigation Tool: Virus filtration, such as Virosart Media, is a powerful upstream strategy to reduce virus contamination, especially in chemically defined cell culture media.
3. Process Challenges: Standard virus clearance can deactivate active ingredients in ATMPs. Additionally there is a lack of comprehensive downstream virus clearance steps.
4. Implementation Benefits: Virus filtration can be integrated into single-use processes, offering scalability and reducing cross-contamination risks from lab to commercial production.
5. Regulatory Encouragement: Guidelines like ICH Q5A (R2) support complementary virus risk mitigation strategies when downstream clearance is difficult.