Assessing the application of standardized processes in cell and gene therapy development and manufacturing.

As the cell and gene therapy (CGT) field evolves, standardized processes have emerged as a popular method to accelerate development timelines, reduce costs, and improve scalability, all contributing to faster patient access to breakthrough therapies. However, the adoption of these processes may present challenges, including potential inflexibility and restrictive protocols that can limit optimal performance and robustness.

In this webinar, experts in CGT development, regulatory affairs, and CMC strategy will provide practical guidance on evaluating the potential risks and rewards of leveraging standardized processes and how to assess what approach is best for your unique product. Attendees will also gain insight into Thermo Fisher’s Rapid Development Framework™, an alternative to traditional platform processes for viral vectors and cell therapies designed to expedite the development and manufacturing process while remaining adaptable to customized methods.

You will learn from this webinar:

• Insights into the advantages and limitations of standardized approaches in CGT development
• Regulatory implications of leveraging a standardized approach
• Suggested criteria for evaluating whether a standardized approach suits your CGT product
• Overview of Thermo Fisher’s Rapid Development Framework™