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.