Contamination of a biological product with viruses, potentially harmful for humans, is of concern for therapeutics derived from human and animal sources, i.e. plasma, and for protein therapeutics and vaccines produced in mammalian cells.  More recent “Advanced Therapeutic Medicinal Products (ATMPs)”, such as gene and cell therapies, share the same concern.  Tests for viral contaminants are performed at several stages of manufacturing.  Current tests for the detection of viruses are lengthy; cell culture based assays and animal experiments are required.  Alternative molecular tests, such as “next-generation sequencing (NGS)”, provide faster results, and can eventually replace in vivo animal studies.  It is noteworthy that identification of a viral contaminant that evaded detection in classical tests, by NGS, has been demonstrated.  In addition, due to the fast turnaround time, the application of targeted NGS for “in process” detection of viral contaminants can be envisioned.  Current efforts for the development of unbiased and targeted NGS based viral safety assays will be discussed.

Presented by:

• Jurgen Mullberg Associate Director at Bristol Myers Squibb
• Joanna Zmurko, NGS specialist at PathoQuest, Biologics Genomic Service