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Synthetic Genomics Launches cGMP Suite for Pharmaceutical Quality Manufacturing of Synthetic DNA for Advaxis’ Clinical Trials

SAN DIEGO, June 1, 2017 /PRNewswire/ — Synthetic Genomics, Inc. and Advaxis, Inc. (ADXS) announced today that they have completed development and deployment of the first current good manufacturing practice (cGMP) synthetic biology facility for the production of synthetic DNA constructs. The cGMP suite has been designed to meet cGMP Phase 1 clinical quality and manufacturing requirements mandated by the FDA. The suite will be used to develop synthetic DNA constructs for Advaxis’ upcoming Phase 1 clinical trial of ADXS-NEO, a personalized, neoantigen-targeted cancer immunotherapy. At the core of the suite is the BioXp™ 3200 System, the world’s first benchtop automated genomic workstation that customers can purchase in an expandable fashion, combined with proprietary Synthetic Genomics genome synthesis tools to manufacture precision DNA constructs. The facility is based at SGI-DNA, a subsidiary of Synthetic Genomics.

2017-06-20T12:07:43+00:00