Improving biopharmaceutical quality and safety by implementing a microbial identification strategy in the workflow

Following biopharmaceutical production, microorganisms present in drug products can compromise product quality and safety. These microorganisms can be difficult to remove and if present, may cause anaphylactic shock and even death in patients. Consequently, regulatory agencies require biopharmaceutical production facilities to implement an environmental monitoring program to enable drug product sterility. The Applied Biosystems MicroSEQ™ Rapid Microbial Identification System was designed to meet regulatory expectations for microbial control in cell and gene therapy workflows. This Webinar Digest summarizes the key aspects of the rationale and regulatory expectations for an effective environmental monitoring paradigm.

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