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

Webinar On Demand

As the cell and gene therapy (CGT) field continues to evolve, standardized processes have emerged as a popular strategy to help accelerate drug development timelines, reduce costs, and improve scalability—all contributing to faster patient access to breakthrough, often life-changing therapies. However, adopting these standardized processes can present challenges for biotech and pharma companies, including potential inflexibility and restrictive protocols that may limit optimal performance and robustness.

This webinar features experts in CGT development, regulatory affairs, and CMC strategy, offering practical guidance on evaluating the risks and rewards of leveraging standardized processes and determining the best approach for your unique product. Attendees will also gain insight into our Rapid Development Framework™, an alternative to traditional platform processes for viral vectors and cell therapies designed to expedite development and manufacturing while remaining adaptable to customized methods.

Key takeaways include:

  • Insights into 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™