Environmental Monitoring for Cell Therapies

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Control your manufacturing environments

 

Environmental monitoring is an essential component of contamination control in cell therapy manufacturing. It is a systematic approach to ensure that cell therapy products 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.

Watch to learn more about the path toward regulatory compliance.

Implement rapid and accurate microbial identification

Microbial identification is a vital aspect of environmental monitoring in cell therapy manufacturing. It plays a crucial role in determining the presence of various microorganisms within the manufacturing environment, with species-level identification as a minimum requirement. Regulatory agencies prioritize genotypic identification over phenotypic methods, considering it to be a more reliable approach in ensuring the safety and quality of cell therapy products.

The Applied Biosystems MicroSEQ Rapid Microbial Identification System is ideal for contamination source identification, root cause analysis, risk assessment, and raw materials testing in cell therapy 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 manufacturing facilities on a global level.

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For Research Use or Further Manufacturing. Not for diagnostic use or direct administration into humans or animals.