CMC Biologics, River Vision sign manufacturing agreement for Teprotumumab to treat Grave's Orbitopathy

NewsGuard 100/100 Score

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, announced today that they have entered into an agreement for the process transfer and cGMP production of RV001 (Teprotumumab) – a recombinant monoclonal antibody targeting insulin-like growth factor 1 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 optimization, 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 CEO 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."


The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Cellular Origins and Cell and Gene Therapy Catapult collaborate to demonstrate universal automation of CGT manufacturing