Contaminant & Impurity QC Testing
Life Technologies offers SEQ rapid molecular methods for pharmaceutical manufacturing to help ensure the quality and safety of your pharmaceutical products, especially when accuracy and time-to-results are critical. These methods help detect impurities and identify contaminants by using molecular techniques such as DNA sequencing, PCR, and real-time PCR, and are fast becoming the standards for pharmaceutical analytics worldwide.
SEQ rapid molecular methods are also ideal for use in public health laboratories, cosmetics and personal care products manufacturing, food testing laboratories, and academic and research centers.
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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.
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.
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.
Have questions about Gibco® media, POROS® chromatography resins, Applied Biosystems® SEQ rapid contaminant tests, or our Cell Therapy products? Click below to access product brochures, training videos, mobile apps, and more.
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