Enzyvant, a subsidiary of Roivant Sciences, has selected Avid Bioservices as the commercial drug substance manufacturer for RVT-801, its recombinant human acid ceramidase enzyme replacement therapy being developed as a potential treatment for Farber disease. Successful technology transfer and clinical manufacturing have been underway since mid-2017 and Avid will complete process characterization and optimization followed by process validation in support of Enzyvant’s ongoing development and regulatory activities for RVT-801, which include the initiation of a first-in-human clinical study.

RVT-801 will be manufactured in Avid Bioservices’ Myford facility, which is designed with cutting-edge, single-use equipment to accommodate a fully disposable biomanufacturing process. A wide range of innovative features are incorporated into this new facility including monolithic modular clean rooms, dedicated support utilities for each key processing area, and the industry’s most advanced single-use production systems and flexible solutions. Uni-directional process flows separate personnel and materials and provide assurance that the design meets the most stringent regulatory requirements for commercial biologics API manufacturing.

“We are delighted to add Enzyvant to the growing list of companies that recognize Avid Bioservices’ ability to move critically important therapeutic products very rapidly into commercial manufacture,” said Roger Lias, president and chief executive officer, Avid Bioservices. “We take great pride in our more than 12-year track record of successfully manufacturing and releasing commercial biologic products for the U.S., EU and numerous other important international markets.”

Alex Tracy, vice president of pharmaceutical development and manufacturing, Roivant Sciences, said, “We presented Avid with very ambitious timelines for RVT-801 manufacturing work and we were extremely impressed with the ability of their team to work creatively with us to design and deliver a program that meets our needs and contributes significant value. We look forward to advancing the development of RVT-801 as a potential therapeutic for Farber’s disease.”