Outsourcing-Pharma.com presents a roundup of contract manufacturing deals, including business for Lonza and Cytovance.
Five Prime Therapeutics has inked deals with Lonza and BioWa to use their Potelligent Chok1sv cell line for production of antibodies in its oncology pipeline. The cell line uses engineered glycosylation technology from BioWa in conjunction with the GS gene expression system from Lonza.
“The combination of the clinical validation seen with other Potelligent antibodies and the track record of the GS cell line were key to our decision to select this system”, said Michael Kavanaugh, senior vice president, research and development at FivePrime, said.
Cytovance Biologics has won a contract to create the manufacturing platform for an osteoporosis drug, PTH-CBD, in development at BiologicsMD. Development of the manufacturing platform will move BiologicsMD closer to its goal of running Phase I trials of the treatment for osteoporosis.
“Our experienced staff and state-of-the-art facilities are prepared to deliver the highest quality of manufacturing services for successful completion of this clinical milestone for the PTH-CBD programme”, Darren Head, president and CEO of Cytovance Biologics, said.
Adventrx Pharmaceuticals has chosen Pierre Fabre Medicament to manufacture the API (active pharmaceutical ingredient) for Phase III trials of its treatment for sickle cell disease, ANX-188.
“Our dedicated supercritical fluids unit, chosen by Adventrx to manufacture the ANX-188 active ingredient, will have the opportunity to put its cutting-edge expertise at the service of a unique manufacturing process”, Frederic Duchesne, president pharmaceuticals division of Pierre Fabre, said.
In 2010 Adventrx’ use of a third-party manufacturer led to a setback for ANX-530. Adventrx moved to a new vendor mid-development and this led to the US Food and Drug Administration (FDA) citing a lack of data from the commercial manufacturing plant in a refuse to file letter.
A second filing was made a year later but this time problems with the contract research organisation (CRO) that handled the bioequivalence trial caused another FDA setback. Adventrx is now seeking a partner or outside investor for ANX-530 while focusing its resources on ANX-188 and other drugs.