Environmental monitoring: optimizing microbial control in cell and gene therapy workflows
Sponsor
Live30 webinars are thirty-minute presentations designed to update you on the latest innovations, applications, and data in a fast yet interactive format.
Microbial control within biopharmaceutical production, such as cell and gene therapy manufacturing, is a critical quality control to ensure drug products are free from viable microorganisms, which can otherwise harm patients and compromise product quality. Implementation of an effective environmental monitoring program is required as part of good manufacturing practice (GMP) guidelines, whereby at minimum, the program should require identification of microorganisms to species level. Although various techniques exist, genotypic identification is considered to be the gold standard for microbial identification, because a DNA sequence has the potential to offer an unambiguous result.
During this webinar we will present our Applied Biosystems MicroSEQ™ Rapid microbial identification system, designed to support the recommended qualification guidelines by regulatory agencies worldwide. Used in top pharmaceutical companies worldwide, the microbial identification system is an end-to-end rapid genotypic sequencing solution based on ribosomal gene sequencing for bacterial and fungal species-level identification. The system generates accurate results in less than 5 hours.
Join this webinar to learn more about:
- Rationale and regulatory expectations for microbial control strategy in bioproduction/ cell and gene therapy workflows
- MicroSEQ™ ID system workflow for bacterial and fungal identification
- Comparison of methods for microbial identification
SPEAKERS