AGTC Announces Productivity and Quality Enhancement To Its Proprietary Manufacturing Process

Applied Genetic Technologies Corporation (AGTC) provided an update on the productivity and quality improvements made in its proprietary manufacturing platform that is currently being used to create clinical trial material for the company’s planned pivotal clinical trials in X-linked retinitis pigmentosa (XLRP).

“Continuous improvements to our proprietary HSV-based manufacturing process have been a critical AGTC objective for more than a decade, and our efforts have resulted in AAV vector quality and yields that we believe exceed the performance and economics of other currently available approaches to produce AAV gene therapy products, particularly those using adherent cell platforms,” Dave Knop, PhD, Head of Process Development at AGTC, said in a company news release. “We are now achieving finished product specifications that demonstrate nearly 90% full capsids with extremely low residuals, many of which fall below the level of detection, resulting in purity levels exceeding 97%. This is in addition to yields that are more than 10-fold higher than what we achieved in our phase 1/2 manufacturing campaigns. What this means is we are already at commercial scale manufacturing for our ophthalmology programs since we can produce thousands of low cost doses from a 40L bioreactor, and our scalable bioreactor format is designed to enable us to meet the production demands for large market indications and indications that may require substantially higher dosing.”

Dr. Knop and Sue Washer, President and CEO of AGTC, recently authored an article on the challenges of AAV manufacturing at larger scale in the June issue of BioProcess International.

“The future of AAV-based gene therapy products will require high quality, robust and consistent manufacturing technology that can deliver safe and efficacious therapies in a cost-effective manner,” said Ms. Washer. “Our long-standing focus on manufacturing improvements and building our manufacturing-related intellectual property portfolio have enabled us to establish a leadership position that we believe will support our growth and success in 2020 and beyond.”