污染物及杂质质控测试

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

支原体是已知最小的可自主生存的生物体，是哺乳动物细胞培养中的常见污染菌。 为确保产品质量，监管机构推荐检测所有细胞培养产物中是否存在支原体。 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. 这使您可以对细胞系、细胞库进行多点检测并收获培养基，提高产率并降低下游污染风险。

• 检测超过90 种支原体
• 业经证明的灵敏度低于 10 拷贝/反应
• 特异性
• 专有的样品制备方法经过优化，DNA回收率高
• 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