SEATTLE, WA, NEW YORK, NY, USA and COPENHAGEN, Denmark I July 29, 2015 I 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.”
About Graves’ Orbitopathy
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.
About River Vision Development Corp.
River Vision Development Corp. was founded by Narrow River Management, LP (Narrow River) for the sole purpose of developing RV001 for GO and other potential indications. The Company is managed under contract with Narrow River, which funds and provides leadership expertise for special purpose drug development companies.
About CMC Biologics
CMC Biologics is leading the industry among CMOs in customer satisfaction, technical excellence, and quality – Right and On Time. With three facilities in the USA and Europe, the Company provides fully integrated biopharmaceutical development and manufacturing solutions to clients globally. The Company has proven expertise in delivering custom solutions for the scale-up and cGMP manufacture of protein-based therapeutics for pre-clinical, clinical trials and commercial production. The Company’s wide range of integrated services includes cell line development, bioprocess development, formulation and comprehensive analytical testing. Clients can also benefit from CMC Biologics’ proprietary CHEF1® expression system for mammalian production. CMC Biologics has fully segregated microbial fermentation and mammalian cell culture suites and offers both fed-batch and perfusion production processes. More detailed information can be found at www.cmcbiologics.com.
SOURCE: CMC Biologics
Post Views: 40
SEATTLE, WA, NEW YORK, NY, USA and COPENHAGEN, Denmark I July 29, 2015 I 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.”
About Graves’ Orbitopathy
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.
About River Vision Development Corp.
River Vision Development Corp. was founded by Narrow River Management, LP (Narrow River) for the sole purpose of developing RV001 for GO and other potential indications. The Company is managed under contract with Narrow River, which funds and provides leadership expertise for special purpose drug development companies.
About CMC Biologics
CMC Biologics is leading the industry among CMOs in customer satisfaction, technical excellence, and quality – Right and On Time. With three facilities in the USA and Europe, the Company provides fully integrated biopharmaceutical development and manufacturing solutions to clients globally. The Company has proven expertise in delivering custom solutions for the scale-up and cGMP manufacture of protein-based therapeutics for pre-clinical, clinical trials and commercial production. The Company’s wide range of integrated services includes cell line development, bioprocess development, formulation and comprehensive analytical testing. Clients can also benefit from CMC Biologics’ proprietary CHEF1® expression system for mammalian production. CMC Biologics has fully segregated microbial fermentation and mammalian cell culture suites and offers both fed-batch and perfusion production processes. More detailed information can be found at www.cmcbiologics.com.
SOURCE: CMC Biologics
Post Views: 40
