Mammalian, insect, or human cell lines used in biologics production may introduce viral contaminants. Since routine viral testing is not performed during manufacturing, VCS is critical to ensure product safety and support regulatory submissions, including IND and BLA filings.
Our studies are conducted in compliance with ICH Q5A(R2) guidelines and meet regulatory expectations from the FDA and EMA.
VCS Program Flow
1. Study Design & Pre-Test Sample Shipment: Initial planning and protocol development, including virus selection. The client provides pre-test samples for compatibility assessment.2. Pre-Test Sample Evaluation: Evaluation of pre-test materials for cytotoxicity and assay interference to determine appropriate non-toxic and non-interfering dilutions for viral assays.
3. Shipment of Study Materials: Once pre-test compatibility is confirmed, the client ships all remaining study materials required for the full execution of the VCS.
4. Viral Spiking & Clearance Execution: Test samples are spiked with selected viruses and processed through relevant purification steps to simulate actual manufacturing conditions.
5. Sample Testing & Data Analysis: Processed samples are analyzed using infectivity assays and/or qPCR (if applicable). Log reduction values (LRVs) are calculated for each purification step.
6. Final Reporting: Preparation of a comprehensive, regulatory-compliant study report. All data undergo full QA/QC review to ensure accuracy and submission readiness.
