Addressing regulatory guidance for HEK293 cells and AAV-based therapeutic manufacturing
On demand

Addressing regulatory guidance for HEK293 cells and AAV-based therapeutic manufacturing

Thursday 09:00 PDT / 12:00 EDT / 17:00 BST / 18:00 CEST
Addressing regulatory guidance for HEK293 cells and AAV-based therapeutic manufacturing

Live30 webinars are thirty-minute presentations designed to update you on the latest innovations, applications, and data in a fast yet interactive format.

With the advances in therapeutic treatment modalities comes the potential to revolutionize the treatment of various diseases and significantly improve patients' lives. However, due to their unique characteristics, ensuring product quality, safety, and potency remains of utmost importance. With the evolving regulatory landscape for advanced therapies, it is crucial to keep up with the latest guidance to ensure compliance and successful product development.

In this webinar, we will discuss the latest regulatory challenges to manufacturers of HEK293- and AAV-based therapies, as well as integrated solutions that will fit in with both upstream and downstream processes.

  • Attend this webinar to enhance your understanding of:
  • The latest regulations affecting those using HEK293 cells or AAV-based therapies as they pertain to
  • Quantitating residual host cell DNA and analyzing its size via E1A
  • Quantitating residual plasmid DNA
  • Detecting the presence of the E1A oncogene
  • What regulatory agencies are looking for in a validated method for manufacturing
  • Integrated solutions leveraging real-time PCR or dPCR technologies
Michael Brewer
Michael Brewer
Director, Global Principal Consultant, Regulatory, BioProduction Group (BPG), Thermo Fisher Scientific

Michael Brewer is the Director, Global Principal Consultant, Regulatory for the BioProduction Group (BPG) at Thermo Fisher Scientific. In this role, Michael is responsible for providing global support to BioProduction customers and serving as the regulatory thought leader and expert across all technology areas within BPD. Prior to moving to this role, he led the Pharma Analytics business, a team responsible for development and commercialization of testing applications for Microbiology, Analytical Sciences and Quality control. The products are fully integrated solutions for Glycan profiling, Bacterial and Fungal identification, Mycoplasma and Viral detection and host cell DNA and protein quantitation. Michael has over 30 years’ experience in the Biopharma industry, including, Scios, Synergen and Amgen in a variety of roles including Discovery Research, Analytical Sciences and Quality Control. Prior to joining Thermo Fisher Scientific, he led a group at Amgen that developed qualified, validated and implemented molecular methods for host cell DNA quantitation, contaminant (Mycoplasma, Virus and Bacteria) detection, contaminant identification, strain typing and genotypic verification of production cell lines. Additionally, his group supported regulatory submissions including IND, NDA, and CMC updates, Regulatory inspections, NC/CAPA investigations, contamination investigations and remediation and developed regulatory strategy for implementation of new methods.