CMC Biologics, a global leader in clinical and commercial manufacturing of therapeutic proteins, and River Vision Development Corporation (River Vision), a private company focused on ophthalmology, have entered into an agreement for the process transfer and cGMP production of RV001 (Teprotumumab) – a recombinant monoclonal antibody targeting insulin-like growth factor  that is in development for treatment of Grave’s orbitopathy and other indications.

Under the agreement, CMC Biologics will transfer River Vision’s manufacturing process for Teprotumumab into its facility in Copenhagen, Denmark for process optimisation, validation and cGMP manufacture to support River Vision’s phase III clinical trials and future commercial supply requirements for both the United State and Europe. Teprotumumab has been designated with an Orphan Drug indication in the US by FDA for Graves orbitopathy.

“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,” said Gustavo Mahler, PhD, global chief operations officer of CMC Biologics.

“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.

“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,” said Dave Madden, president and chief executive officer of River Vision.

“Through this agreement, River Vision and CMC Biologics will work together to advance a treatment for Grave’s orbitopathy – a rare and highly morbid medical condition – and bring a novel therapy to patients in need.”

Graves’ orbitopathy is an autoimmune inflammatory disorder affecting the orbit around the eye, characterized by upper eyelid retraction, lid lag, swelling (edema), redness (erythema), conjunctivitis, and bulging eyes (proptosis). It is part of a systemic process with variable expression in the eyes, thyroid, and skin, caused by autoantibodies that bind to tissues in those organs, and, in general, occurs with hyperthyroidism.