Accelerate Biologics Product Release With Seamless Viral Testing

Moderated by Stacey Victor, this webinar brings together experts Dr. Heather Byer, Dr. Laura Strittmatter, and Noah Horn to discuss key aspects of viral safety testing in biologics. The session centers on unprocessed bulk testing, regulatory updates, and best practices to ensure product safety.

Viral safety relies on three pillars: prevention, detection, and removal. Prevention involves testing raw materials and cell lines to avoid contamination. Detection uses orthogonal methods—such as in vitro and in vivo assays, PCR panels, and electron microscopy—to identify adventitious agents including viruses, bacteria, fungi, and mycoplasma. Removal is addressed through viral clearance studies during downstream processing.

A major focus is unprocessed bulk testing, which targets material directly from the bioreactor before purification. Regulatory guidelines, including updated ICH Q5A, support minimal sample processing to enhance detection sensitivity. Early detection at this stage is crucial to prevent cross-contamination of downstream systems.

Audience polling highlighted common challenges: long turnaround times, product-specific assay interference, and high costs. Despite these, certain tests remain mandatory. Microbial testing (e.g., bioburden, sterility, and mycoplasma) is conducted on every lot, alongside adventitious agent testing. Additional assessments—like retrovirus testing, PCR for known agents, and electron microscopy for quantification—are performed based on risk.

In vitro viral screening assays use indicator cell lines selected for susceptibility to relevant viruses. These assays detect cytopathic effects and employ hemadsorption or hemagglutination tests, with large-volume formats and sample-specific interference testing recommended.

Overall, the webinar emphasizes a risk-based, layered approach to viral safety in biologic manufacturing.