Expectations on the Pathway to GMP for Gene-Modified Cell Therapies
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Moving beyond research and development, gene and cell therapy developers face significant challenges when initiating clinical programs that rely on CRISPR technology. Increasing regulatory scrutiny, GMP manufacturing lead times, and complex production processes complicate the task of moving a program into the clinic and scaling to serve larger patient populations.
To help navigate this challenging landscape, Aldevron has begun manufacturing batches of ribonucleoprotein (RNP) for clients using its GMP manufacturing facility.*
Switching to Aldevron’s GMP-compliant RNP manufacturing process for clinical cell therapy enables drug developers to scale up and meet heightening regulatory requirements.
*Aldevron provides RNPs only to customers who are duly licensed, including to make and have made RNPs, for their intended use.