Accelerating Cell & Gene Therapy Success with cGMP Gene Editing Components and Regulatory Compliance

The manufacturing of gene editing (GE) components is a pivotal aspect of GE-based Cell and Gene Therapy development, requiring meticulous attention to product quality and regulatory compliance throughout the development lifecycle. In this webinar, we will discuss the key differences between GE components used from early discovery through to clinical application, and provide insight into how phase-appropriate components can be used to achieve clinical objectives while balancing quality and cost.
In this webinar, you will learn:
• The distinctions between RUO, preclinical, and clinical grade (under cGMP) gene editing components
• Case studies on the challenges of off-target insertions and degradation, and the development of strategies to mitigate these issues in CGT development
• How manufacturing capabilities, analytical service,s and regulatory support help in making successful IND submissions
• How the use of phase-appropriate components can optimize clinical outcomes cost-effectively