May 12, 2023 -- Genome engineering company Synthego on Thursday announced the opening of an 18,000 square-foot good manufacturing practice (GMP) synthesis facility for gene editing components.
The new facility features 24/7 operations, fully automated controls, multiplexed manufacturing lines, and an integrated manufacturing execution system. The facility will produce a range of oligonucleotides, including synthetic single guide RNAs, and has been designed to meet the requirements of both domestic and international regulatory authorities, including the U.S. Food and Drug Administration (FDA) and Health Canada, Synthego said.
The facility also includes dedicated process development, analytical testing, and quality control areas, the company added.
Redwood City, CA-based Synthego offers custom synthetic guide RNAs in three different classes for different stages of the development of CRISPR-enabled therapeutics and diagnostics: research grade, an intermediate "GMP-like" grade, and GMP quality.
"This represents a significant step towards removing industry bottlenecks and helping accelerate access to life-changing and lifesaving CRISPR-enabled cell and gene therapies," Paul Dabrowski, CEO of Synthego, said in a statement.