CMC Biologics Powers River Vision's Grave Orbitopathy Treatment
SEATTLE, WA: CMC Biologics, process developer and manufacturer of biopharmaceuticals signs agreement with River Vision Development Corporation (River Vision), a company focused on ophthalmology, for process transfer and cGMP production of RV001(Teprotumumab)- a recombinant monoclonal antibody targeting insulin-like growth factor 1 that is under development for treatment of Grave’s Orbitopathy and other indications. Grave Orbitopathy is autoimmune inflammatory disorder affecting the orbit around eyes such as swelling, redness, conjunctivitis and bulging of eyes.
This agreement will bring River Vision and CMC Biologics together for advance treatment in Grave’s Orbitopathy for patients in need. "River Vision's requirement for late phase and commercial manufacturing is a natural fit for us and validates our technical excellence in process transfer and large scale production of protein products destined for commercial success, CMC Biologics is committed to rapid transfer and production of Teprotumumab to enable River Vision to achieve their go-to-market strategy as quickly and in the most cost-effective manner possible,” says Gustavo Mahler, PhD, Global Chief Operations Officer of CMC Biologics.
CMC Biologics will optimize Teprotumumab’s manufacturing process, validation and cGMP manufacture to support River Vision’s Phase III clinical trials and future commercial supply requirements for both the U.S and Europe. Teprotumumab has been designated with an Orphan Drug Indication in the US by FDA for Graves Orbitopathy. "We selected CMC Biologics as our a contract manufacturing partner for our Phase III trials because they have the know-how to work in collaboration with our team to successfully transfer our process, and the flexibility to be able to meet our aggressive clinical and commercial manufacturing timelines, which are both are essential to move this program toward the market expeditiously," says Dave Madden, President and CEO of River Vision.