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Control your manufacturing environment
Environmental monitoring is an essential component of contamination control in manufacturing environments. It is a systematic approach to help ensure that biotherapeutics are produced in a safe, clean, and compliant manner, protecting both product integrity and patient safety. The implementation of an environmental monitoring program is required to comply with good manufacturing practices.
Rapid microbial identification
Microbial identification is a critical component of an environmental monitoring program. It involves determining the types of microorganisms present in the manufacturing environment—down to the species level. Due to the characteristics of DNA-based methods, regulatory agencies consider genotypic identification to be more reliable than phenotypic methods.
The Applied Biosystems MicroSEQ Rapid Microbial Identification System is ideal for contamination source identification, root cause analysis, risk assessment, and raw materials testing in biopharmaceutical manufacturing spaces and service laboratories. It combines the benefits of PCR and DNA sequencing technologies to enable highly accurate results and has been implemented in antibody manufacturing facilities on a global level.
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