Navigate CGT Success: Align cGMP Gene Editing with Regulatory Frameworks

Cell and gene therapy is at the forefront of medical innovation, offering transformative potential for treating complex diseases. However, achieving success in these therapies requires meticulous attention to the quality of gene editing components and regulatory compliance. This webinar will explore how quality and regulatory standards for gene editing reagents influence the development and application of these technologies, as well as the FDA's Cell and Gene Therapy Guidance.

Participants will gain insights into the key distinctions between gene editing component grades and their implications for development. We will discuss how a consistent platform can streamline the transition from preclinical stages to clinical trials. Through real-world case studies, we will address common challenges in cell and gene therapy (CGT) development and present effective strategies for overcoming them. Additionally, selecting phase-appropriate components can enhance clinical outcomes while effectively managing costs. Finally, the webinar will highlight how GenScript’s expertise and support contribute to achieving successful Investigational New Drug (IND) submissions and compliance with FDA regulations.

Key Takeaways:

• Gene Editing Component Grades: Differences and impact on development.

• Platform Consistency: Streamlining transitions from preclinical to clinical trials.

• Case Studies: Strategies to overcome common CGT challenges.

• Phase-Appropriate Components: Enhancing outcomes and managing costs.

• GenScript’s Role: Support for successful IND submissions and FDA compliance.

Learning Objectives:

• Understand the Impact of Gene Editing Component Grades
• Ensure Regulatory Compliance with FDA Guidelines
• Gain Insights into cGMP Manufacturing Expertise and Capacity