Synthego Corp., a provider of genome engineering solutions, opened its state-of-the-art GMP synthesis facility. The new 18,000 square-foot facility supports the growing demand for development of high-quality, CRISPR-enabled in vivo and ex vivo therapeutics by pharma and biopharma clients, including via IND and NDA or BLA enabling clinical studies.

The cGMP facility features 24/7 operations with advanced equipment and technologies, including multiple multiplexed manufacturing lines, fully automated controls, and an integrated manufacturing execution system (MES). This enables the company to produce a range of oligonucleotides, including synthetic single guide RNAs, setting the standard for quality and compliance in manufacturing gene editing components. The facility also includes dedicated process development, analytical testing, and quality control areas, ensuring that all aspects of the manufacturing process are closely controlled.

The facility has been designed to meet the requirements of both domestic and international regulatory authorities including the FDA, EMA, MHRA, and Health Canada.

Synthego offers high quality synthetic guide RNAs in three different classes, research grade, GMP-like, and GMP, to support all stages of the therapeutic development process from bench through clinic.

The company said that with the opening of this facility, Synthego is well-positioned to meet the strong customer demand for custom manufacturing of RNA molecules for development of cell and gene therapeutics, and to continue to provide clients with the highest quality products and services.

“We are pleased to open Synthego’s new GMP facility, solidifying our commitment to provide partners with the highest quality CRISPR guides for the clinical development of therapeutics. This represents a significant step towards removing industry bottlenecks and helping accelerate access to life-changing and lifesaving CRISPR-enabled cell and gene therapies.” said Paul Dabrowski, CEO of Synthego. “The design of this facility is the fruition of a decade of experience creating guide RNAs and engineering cells and sets the standard for quality and efficiency of GMP CRISPR reagent manufacturing.”