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We offer 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

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

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The detection, characterization, and removal of process impurities are critical in biopharmaceutical production. Current methods to quantify proteins (e.g., ELISA) typically suffer from narrow dynamic range, low sensitivity, laborious workflows, lack of dilution linearity, and poor robustness when used with complex matrices. The ProteinSEQ™ Protein Quantitation System is an immuno–PCR-based method that addresses these challenges, providing greater confidence and quality of data throughout the quantitation process, including:

  • PCR sensitivity: quantitation to as low as 0.2 ng/mL generic host cell protein (HCP)
  • Wide dynamic range: 4 orders of magnitude
  • Robustness: Dilution linearity and efficiency in complex matrices
  • Semi-automation: 2-hour walk-away time
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Glycosylation is one of the key critical quality attributes of monoclonal antibody–based biotherapeutics. Glycosylation changes can impact a biological drug’s safety, efficacy, clearance, and immunogenicity, making it necessary to accurately detect changes. The Applied Biosystems™ GlycanAssure™ Glycan Analysis and Quantitation System is the first glycan analysis platform that combines both high throughput and high data quality, and offers an integrated glycan analysis platform that helps save labor, time, and cost of analysis.

  • Performance—resolution of sialylated glycans, structural isomers, fucose species, and high-mannose species
  • Ease of use—magnetic bead–based sample preparation using less labor (reduced pipetting and hands-on time); no use of sodium cyanoborohydride; and no vacuum centrifugation steps
  • Data quality—multiple fluorescent dyes for superior sensitivity and selectivity—traditional APTS and the novel Teal™ and Turquoise™ dyes for glycan labeling
  • Throughput—sample preparation and analysis of 96 samples in 7–9 hours
  • Support—full field applications support at every stage of method implementation; system based on proven Applied Biosystems™ CE technology platform from an established, consistent supplier
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SEQ rapid molecular methods videos

Cell Culture Contaminants: Mycoplasma and Viruses

Applied Biosystems SEQ Analytical Solutions for Pharmaceutical manufacturing

Microbial Identification: Bacterial and Fungal ID using MicroSEQ® System

Product and Process Impurities Analysis

BioProduction resources

Have questions about Gibco™ media, POROS™ chromatography resins, Applied Biosystems™ SEQ rapid contaminant tests, or our cell T\therapy products?  Click below to access product brochures, training videos, mobile apps, and more.