Retrovirus Testing By Real Time PCR-Based F-PERT

Ensuring the safety of viral vaccines and biologics requires rigorous testing to confirm that cell substrates and starting materials are free from contaminants1. Among the most significant risks are retroviruses, which use reverse transcriptase to integrate their genetic material into host DNA. While some are non-pathogenic, others are linked to severe conditions, including immune deficiencies and neurological disorders.

To mitigate these risks and meet regulatory standards like ICH Q5A(R2), the Fluorescent Product-Enhanced Reverse Transcriptase (F-PERT) assay provides a highly sensitive solution for detecting retroviral activity. Integrating this approach with modern molecular methods like NGS ensures a comprehensive safety profile and accelerates release testing timelines. Learn how to enhance your virus safety platform.