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Avid Bioservices will provide commercial manufacture of an enzyme replacement therapy by Roivant Sciences' Enzyvant subsidiary.
On Feb. 21, 2018, Avid Bioservices, a contract development and manufacturing organization, announced that it has been selected by Enzyvant, a biopharmaceutical company and subsidiary of Roivant Sciences, a healthcare company, to commercially manufacturing the drug substance for RVT-801, a recombinant human acid ceramidase enzyme replacement therapy being developed by Enzyvant as a potential treatment for Farber disease.
Technology transfer and clinical manufacturing have been underway since mid-2017 and Avid is expected to complete process characterization and optimization, followed by process validation to support Enzyvant's ongoing development and regulatory activities for the therapy. This will include the initiation of a first-in-human clinical study.
Avid Bioservices will manufacture the drug substance at its Myford, CA, facility using single-use equipment to accommodate a fully disposable biomanufacturing process. The facility features monolithic modular clean rooms, dedicated support utilities for each key processing area, and advanced single-use production systems and flexible solutions. The facility also uses a uni-directional process flow to separate personnel and materials, which provides assurance that the regulatory requirements for the commercial manufacturing of biologic active pharmaceutical ingredients are met.
"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, PhD, president and CEO of Avid Bioservices, in a company press release. "We take great pride in our more than 12-year track record of successfully manufacturing and releasing commercial biologic products for the [United States], [European Union], and numerous other important international markets."
Alex Tracy, PhD, vice president of pharmaceutical development and manufacturing for Roivant Sciences, added in the press release, "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."
Source: Avid Bioservices