Implementing rapid microbial identification in biotherapy manufacturing

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Watch On Demand

Join DDW for this free on-demand event, Implementing rapid microbial identification in biotherapy manufacturing: Enhancing quality control and regulatory compliance, which is supported by Thermo Fisher Scientific.

It is presented by Phil Tuckett, BS, RM(NRCM, Department Scientist, Nelson Laboratories and Michelle Thai, Technical Sales Specialist, Pharma Analytics BioProduction Group, Thermo Fisher Scientific.

This event examines focused environmental monitoring within a cGMP facility. Specifically, leveraging the Applied Biosystems MicroSEQ Microbial Identification System in biotherapeutic manufacturing.

Microbial control within biopharmaceutical manufacturing is a critical quality control to help ensure drug products are free from viable microorganisms. Per regulatory guidelines, the implementation of an environmental monitoring programme is required to comply with good manufacturing practices and identification of microorganisms to species level is a minimal requirement. Regulatory agencies consider genotypic identification to be more reliable than phenotypic methods.

Anyone working in the biotech/pharmaceutical industry in QC/QA, microbiological testing or manufacture of biotherapeutics (including monoclonal antibodies, cell therapies, gene therapies, vaccines, or mRNA-based therapeutics) will find this event of interest.

What you will learn:

  • About environmental monitoring within biotherapeutic production
  • Applying the MicroSEQ ID system (including its features and benefits)
  • How a CDMO would utilise this solution for a customer

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