Webinar Implementing rapid microbial identification in biotherapy manufacturing: Enhancing quality control and regulatory compliance
In this webinar, hosted by DDW and sponsored by Thermo Fisher Scientific, we examine 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 program 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.
The presentation will feature a speaker from Nelson Laboratories, a global testing lab specializing in expert advisory and testing solutions for medical device, pharmaceutical, tissue & biologics companies.
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
An audience Q&A session with the presenters follows the webinar presentation.
