The rapid detection and identification of contaminants in intermediates and final product is essential to accelerate 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 and ensure safety. 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)
To check which of our BPS facilities offer PCR testing services, click here. For additional information, contact us at askcharlesriver@crl.com or 1.877.CRIVER.1.
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PCR, nucleic acid amplification, RT-PCR, nucleic acid detection, Mycoplasma detection, Residual DNA analysis, viral nucleic acid detection, Microbial identification, copy number analysis, plasmid copy number analysis, Genetic stability, retroviral enzyme activity, reverse transcriptase
PCR Testing | Charles River Biopharmaceutical Services
Charles River Biopharmaceutical Services 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 and ensure safety.