Abstract

Choosing the right GMP partners for your clinical trials can ensure that your therapy meets the necessary quality standards, ultimately increasing the likelihood of FDA/EMA acceptance. Synthego is a genome engineering company that supports the development of CRISPR-based cell and gene therapies, from discovery to first in human clinical trials. We have developed automated platforms for the small-scale synthesis of CRISPR guide RNAs and engineering cells for discovery research. Synthego was the first to launch a sgRNA GMP facility in 2020 and has produced 92 client batches to date. We will present our approach to helping scientists and clinicians in industry and academia with high-quality CRISPR reagents for their preclinical research work through IND-enabling studies and into the clinic. In addition, we will showcase our new 1,600 sq. m. GMP facility that will start production in a few weeks.