The success of autologous CAR-T therapies such as Kymriah® and YESCARTA® marked a turning point in cell and gene therapy (CGT). These breakthroughs showcase decades of scientific discovery and technological innovation, translating from research concepts into real therapeutic options. However, despite the excitement and investment following these approvals, the “manufacturing problem” has emerged as a critical bottleneck to broader commercial success for this class of highly personalized medicines. This webinar will explore CMC strategies in general, and control strategies in particular, as essential tools to achieving manufacturing success with confidence.

Subject area:
cGMP

Objectives (If applicable):
N/A

Target Audience (If applicable):
Pharmaceutical manufacturing, biomanufacturing, biologics organizations; Job function: process design, quality assurance (QA), quality control (QC), operations managers, quality management, pharmaceutical quality directors, MHA, MPH.