Rapid Development Framework™ solutions for cell and gene therapy
Accelerate your transition from idea to impact with confidence leveraging our standardized processes for cell therapy and viral vector development
With commercial approval rates as low as 10% for gene therapies and 17% for cell therapies at Phase 1, the stakes for early development are high.*
While many factors contribute to this considerable attrition, challenges associated with progressing innovative R&D processes to standardized and robust manufacturing methods are a driving force. Platform processes for cell and gene therapies (CGTs) have emerged as potential solutions to streamline development, but they may impose restrictive protocols that can stifle innovation and result in suboptimal outcomes.
As an alternative to this traditional approach, Thermo Fisher Scientific has developed the Rapid Development Framework™ solutions to accelerate the development and manufacturing of cell therapies and viral vectors while remaining adaptable to the unique needs of each product. These frameworks enable control over your processes while leveraging standardized elements for improved efficiency and reliability—transforming the way CGTs are brought to market.
Reduce development timelines and production costs
Promote consistency and quality across different batches and production sites
Streamline regulatory submission process
Learn more about our Rapid Development Framework™ solutions:
- Workflows for CAR T cells, iPSCs, and associated analytics
- CAR T cells: Includes range of automation options (full or semi-automated and modular approach)
- iPSCs: Supports multiple methods for reprogramming and delivery
- Available assays include flow cytometry, ddPCR, and potency leveraging established parameters to simplify analytical development
- Applicable for transfection-based AAV and LV vectors produced within suspension cell culture and purified with chromatography
- Developed and tested through various clinical stages
- Scale up to 2,000 L (AAV)
- Leverages previously qualified platform analytics
- 9 months to GMP filled drug product
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