Manufacture of CRISPR RNPs for Clinical Use

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Aldevron specializes in manufacturing Cas9 proteins, as well as custom protein development and manufacturing services. Although many vendors offer research grade CRISPR/Cas nucleases, these are not applicable to clinical programs due to construct design and quality grade. While Aldevron is the only manufacturer to offer GMP-grade Cas9 proteins and select vendors offer GMP-grade synthetic single guide RNAs (sgRNAs), there are currently no options for complexing the two as a ribonucleoprotein (RNP) in a GMP-certified process. In an effort to address this gap in manufacturing for therapeutic genome editing, Aldevron has created a method to complex, QC, and characterize RNP complexes under GMP conditions. We will review our findings in this presentation.

Speaker - Shawn Shafer, Ph.D., Genome Editing Platform Lead, Aldevron