Contaminant & Impurity QC Testing

Harmful bacteria and fungi can contaminate raw materials, production facilities, and branded products. The use of a phylogenetic approach for microbial detection based on the 16S rRNA gene for bacteria or a specific genomic region of the large subunit for fungi can help prevent delayed product releases, back orders, and even recalls.

Identify thousands of bacterial and fungal species typically in under 5 hours with the MicroSEQ® Microbial Identification System

Mycoplasmas, the smallest known free living organisms, are relatively common bacterial contaminants of mammalian cell cultures. Regulatory guidance requires that all products derived from mammalian cell culture be tested for the presence of Mycoplasma. The MycoSEQ™ Mycoplasma Detection System integrates real-time PCR assays, instruments, and software with optimized PrepSEQ® sample preparation reagents - delivering results in hours, not days. This enables you to test at multiple points in cell lines, cell banks, and harvest media, increasing your productivity and reducing risk of downstream contamination.

• Detection of more than 90 Mycoplasma species
• Demonstrated sensitivity to less than 10 copies/reaction
• Proven specificity
• Proprietary optimized sample preparation for high DNA recovery
• Externally validated to demonstrate sensitivity of a PCR based test for Mycoplasma that is not biased towards the success of PCR
• Seamless integration from detection to identification using the MycoSEQ™ Full Gene 16S rDNA Bacterial Identification Kit

The removal of host cell impurities is a critical step in the purification of biopharmaceutical products. A major challenge is the accurate and sensitive quantitation of host cell DNA impurities in both the purification process and in drug substance samples.

• Quantitate host cell residual DNA typically in under 5 hours with the resDNASEQ® Residual DNA Quantitation Assays  for E. coli and Pichia
• Recover high levels of DNA from complex matrices with the PrepSEQ® Residual DNA Sample Preparation Kit
• Analyze results with AccuSEQ® Real-Time PCR Detection Software

MMV and Vesi virus contamination is a potential threat to mammalian cell culture manufacturing processes. Multiple cell culture manufacturing facilities have been negatively impacted over the past 20 years following contamination with these viruses. The ViralSEQ® Detection System is an integrated DNA purification and real-time PCR-based test for rapid, sensitive detection of MMV and Vesi virus from a wide range of sample types.

• Detection of all known Mouse Minute Virus (MMV) and Vesi virus strains
• Proven TaqMan® technology for highly sensitive detection down to 10 DNA copies per reaction (viral particles equivalent to 0.002 TCID₅₀)
• Specific, no cross-reactivity with unrelated DNA
• Discriminatory positive/extraction DNA control to mionimize the possibility of false positive test results from accidental cross-contamination with control DNA
• Use with Prep SEQ® 1-2-3 Nucleic Acid Extraction Kit, which is optimized for highly efficient DNA recovery
• Rapid time-to-results, typically in less than 4 hours

Identify thousands of bacterial and fungal species in under 5 hrs with the MicroSEQ® Microbial Identification System