Merck
CN
HomeWebinarsAccelerated Monoclonal Antibody Development: Advance from Transfection to GMP Drug Substance in 9 Months

Accelerated Monoclonal Antibody Development: Advance from Transfection to GMP Drug Substance in 9 Months



WEBINAR

The Accelerated mAb development program reduces development timelines for IgG1 and IgG4 monoclonal antibodies to 9 months using an established, phase-appropriate process that is scalable and integrates strategies for risk mitigation. The program is designed to ensure that quality, safety, and regulatory requirements for IND/IMPD filing and early clinical trials are met, and a robust foundation for future commercial-scale production is established. In this webinar, you’ll hear from some of the experts who were instrumental in developing the Accelerated mAb development program and work with our biotech clients on a daily basis to accelerate their timelines toward the production of GMP drug substances.

In this webinar, you will learn about:

  • The strategies used in the Accelerated mAb development program that allow clients to rapidly advance to GMP drug substance production with confidence.
  • The time and cost savings that can be achieved using streamlined unit operations and scale-up processes.
  • How the analytical package was designed to be phase appropriate and accelerate timelines. 

Speakers

Armelle Gilletta de Saint Joseph

Armelle Gilletta de Saint Joseph

Merck

Analytical Laboratory Supervisor

Angéline Rodrigues-Antunes

Angéline Rodrigues-Antunes

Merck

Operational QA Expert

Jean-Baptiste Noirot-Cosson

Jean-Baptiste Noirot-Cosson

Merck

Head of Manufacturing Science and Technology, Biologics CDMO

Jean-Baptiste joined Merck as a bioproduction process and equipment engineer in 2013. Since he joined the company, he has been responsible for leading the technical transfer of biotech products and the cleaning and process validation (PPQ) for new products as well as supporting the troubleshooting of clinical and commercial manufacturing. His role expanded in 2014 when he became Manufacturing Science and Technology Manager for our Biologics CDMO and took on the responsibility of setting up a Manufacturing Science and Technology team to continue driving these activities.

Emilie Cester

Emilie Cester

Merck

DSP Development Expert

Carole Monerie-Moulin

Carole Monerie-Moulin

Merck

DSP Innovation Expert

Webinar Information

Pharma and biopharma manufacturing

  • Monoclonal antibody manufacturing
  • Duration:30min

  • Language:English

  • Session 1:presented August 24, 2023

    Register Now


Sign In To Continue

To continue reading please sign in or create an account.

Don't Have An Account?