The rapid detection and identification of contaminants in intermediates and final products is essential to biopharmaceutical product pipeline development. Charles River Biopharmaceutical Services (BPS) offers nucleic acid amplification technology (NAT)-based detection and quantification methods, such as PCR and RT-PCR, to detect the presence of bacterial, viral and host cell nucleic acids. PCR is an established, highly sensitive, reliable, time-efficient method that can be validated for the detection and identification of contaminants. NAT-based methods can also be applied to cell line characterization and process validation.
Applications of PCR include:
- Mycoplasma detection validated according to European Pharmocopeia guidelines
- Residual DNA analysis for a wide range of species
- Viral nucleic acid detection
- Microbial identification by PCR and DNA sequencing
- Plasmid copy number analysis of recombinant target sequences in microbial and mammalian systems
- Genetic stability
- Retroviral enzyme activity (reverse transcriptase)
Charles River has also developed rapid, sensitive and specific broad-range PCR assays to help you to receive your results faster and ensure that you have the information necessary to make decisions in your development and production processes. The new assays are aimed at detecting the following viruses:
- Human and canine adenoviruses
- Human and canine herpesviruses
- Human and canine papillomaviruses
- Human polyomaviruses
To check which of our BPS facilities offer PCR testing services, click here. For additional information, contact us at email@example.com or 1.877.CRIVER.1.