Accelerating Cell & Gene Therapy Success with cGMP Gene Editing Components and Regulatory Compliance (Previously recorded)
Summary:
Producing cell and gene therapies is a complex process involving multiple products from various sources, which adds to the overall complexity. One of the significant challenges for researchers and biotech companies is sourcing the essential materials to ensure product consistency. Outsourcing or manufacturing gene editing (GE) components is crucial in Cell and Gene Therapy development, requiring careful attention to product quality and regulatory compliance throughout the entire lifecycle.
In this webinar, Dr. Jianpeng Wang, Senior Director, explains the key differences between GE components used from early discovery to clinical application. He shares insights into how phase-appropriate components can be leveraged to achieve clinical objectives while balancing quality and cost Dr. Wang also discusses the critical differences in documentation and standards that differentiate research use only (RUO), preclinical, and clinical grades (under cGMP), and how these affect the development and eventual use of GE components in CGT development.
Key Takeaways:
- The distinctions between Research Use Only (RUO), preclinical, and clinical-grade (under cGMP) gene editing components.
- Case studies highlighting challenges such as off-target insertions and degradation, and strategies to address these issues in CGT development.
- GenScript manufacturing capabilities, analytical services, and regulatory support in successful IND submissions.
- How phase-appropriate components can be strategically used to optimize clinical outcomes cost-effectively.