Article | May 18, 2016

Missed Opportunities For Adventitious Agents Testing

Source: Parenteral Drug Association (PDA)
biopharma manufacturing

By Sven M. Deutschmann, PhD, Roche Diagnostics GmbH

Current adventitious agent test methods feature numerous limitations. Assays based on polymerase chain reaction (PCR) offer the potential to lift these limitations and offer better overall detection of adventitious agents. This is an area that biologics manufacturers are actively exploring, and current research indicates that PCR-based testing is not only scientifically valid but also acceptable to regulators.