Missed Opportunities For Adventitious Agents Testing
Source: Parenteral Drug Association (PDA)
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.
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Parenteral Drug Association (PDA)
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