Rapid Molecular Detection

Testing for the presence of viruses and microbial contaminants is essential to any overall biosafety testing strategy for the manufacturing of monoclonal antibodies (mAbs), cell and gene therapies, and vaccines. However, traditional detection methods requiring biological amplification, such as in vivo or in vitro expansion can require several weeks and large quantities of materials – not only making them incompatible with gene-modified cell therapies and other advanced therapy medicinal products (ATMPs), but also preventing manufacturers of mAbs and vaccines from realizing the benefits of accelerated cell line characterization and reduced risk via in-process screening.

Our scientific, regulatory, and quality assurance experts stand ready to guide you in the selection of rapid detection methods that will enable acceleration of your biosafety testing package, while addressing issues with limited sample volume. These include:

• Highly sensitive and targeted polymerase chain reaction (PCR) methods
• Degenerate PCR for more broadly based detection of viral families
• Next generation sequencing (NGS) for rapid identification of known or unknown agents with pinpoint precision and accuracy

Get in touch with an expert today to discuss your next project and find the right approach to accelerate your biosafety testing strategy.