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| Webinar: Navigating Regulatory Challenges For Cell And Gene Products In 2024 And Beyond | A multidiscipline panel of experts will discuss the importance of ancillary and starting materials management control strategies for CGT product development, recent FDA regulatory developments for expedited regulatory pathways for cell and gene therapy products (specifically the recent regulatory initiatives for improving efficiency of accelerated approval pathway), and regulatory considerations crucial for using companion diagnostics in CGT. Click here to learn more. |
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When CGT products demonstrate dramatic improvements with minimal safety concerns in a Phase 2 study, sponsors may want to modify the protocol mid-study to increase patient enrollment. |
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By Life Science Editorial Connect Staff | Implementing more automated workflows in cell therapy manufacturing can serve to minimize open processes and manual touchpoints, increasing reproducibility and improving traceability. |
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| Cryopreservation Best Practices For CGT Source Material | Webinar | Comprehensive Cell Solutions, A Business Unit of NYBC Enterprises | Industry experts share their experiences, including why and how cellular source materials are cryopreserved, the gold standard of cryo practices, and why experience matters. |
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