CMC Biologics Secures Manufacturing Contract for mAb Treatment

July 31, 2015
BioPharm International Editors

CMC Biologics and River Vision Development announce manufacturing agreement for RV001, a monoclonal antibody to treat Grave’s orbitopathy.

CMC Biologics and River Vision Development Corp, announced on July 29, 2015 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 Development Corp. was founded by Narrow River Management to develop RV001 for Grave’s Orbitopathy and other potential indications.

CMC Biologics is a contract manufacturer of therapeutic proteins with three facilities in the US and Europe for biopharmaceutical development and manufacturing solutions to clients globally.

Source: CMC Biologics