AGTC and SAFC Partner To Provide Gene Therapy Manufacturing Services
By Cyndi Root
Applied Genetic Technologies Corporation (AGTC) and SAFC Commercial (SAFC) announced in a press release that they have signed an agreement for SAFC to provide gene therapy manufacturing services. The two companies will focus on AGTC’s gene-based product candidates for rare eye diseases and AGTC’s proprietary HAVE system for manufacturing AAV vectors.
Sue Washer, President and CEO of AGTC, said, “AAV vectors have broad potential in treating a variety of genetic diseases, but until recently, could not be manufactured at clinical and commercial scale in a cost-effective manner.” David M. Backer, Sr. Director and General Manager at SAFC, said, “Partnering with AGTC to provide gene therapy manufacturing services is an effective way to make this important technology available to a broader audience.”
AGTC and SAFC Partnership
The financial terms of the partnership between AGTC and SAFC were not disclosed. The two companies have agreed to co-market AGTC's proprietary HAVE manufacturing method and assist clients with AAV-based vectors. SAFC will manufacture vectors and helper viruses and conduct activities that support early research, clinical trial development, and eventual production. Clients of the two companies will be able to access bio-manufacturing testing services from BioReliance, SAFC's early-development services business. AGTC and SAFC have also agreed to market AGTC’s production system to pharmaceutical companies and to academic entities.
AAV Vectors
The adeno-associated virus (AAV) is a simple virus with two genes that is not known to cause human disease. Engineering AAV vectors consists of using recombinant herpes simplex virus (HSV) to produce vector stock, which is then purified. AGTC's proprietary HAVE manufacturing delivers DNA sequences to correct genetic diseases. AGTC’s AAV vectors have been tested in several disease indications, and clinical testing has shown safety and long-lasting protein expression and effectiveness.
About SAFC
SAFC Commercial, a business unit of Sigma-Aldrich Corporation, is a custom manufacturing and services provider for chemical and biologics companies. In May 2014, the company announced an upgrade at its facility in Sheboygan, WI. Also in May, the company announced a partnership with BioTools to provide customers access to chiral structural determination tools and separation services.