Commercial production by CDMO Lonza follows the recent US FDA nod for Portola’s Prior Approval Supplement (PAS) for recombinant factor Xa product Andexxa. FDA approval of Portola Pharmaceuticals, Inc.’s Prior Approval Supplement (PAS) for second-generation Andexxa follows collaboration with Lonza Pharma & Biotech to develop the manufacturing process The production of this second-generation Andexxa [coagulation factor Xa (recombinant), inactivated] has now begun, with Swiss contract development and manufacturing organization (CDMO) Lonza supplying the recombinant coagulation factor from its Porriño, Spain…
Friday, January 25, 2019 Daily Archives
GE and G-CON extend prefab partnership for gene therapies
GE Healthcare will equip G-CON’s prefabricated cleanrooms with its cell therapy and viral vector technologies in the latest expansion of its partnership. The collaboration aims to incorporate GE Healthcare’s cell therapy and viral vector technologies and process design within G-CON’s prefabricated flexible cleanrooms (known as ‘PODs’) in efforts to speed up and offer flexibility to customers’ advanced therapy projects. “This collaboration is unique because it provides our customers with an entire cleanroom infrastructure from a single source and will improve…
Merck and MIT look to continuous cell-based vaccines in NIIMBL project
An 18-month project partners Merck & Co. with vendor Repligen and academia to develop approaches for continuous cell-culture based vaccine manufacturing. The program, entitled ‘The Continuous Cell Culture for Viral Vaccines’ is being led by the Massachusetts Institute of Technology (MIT), will bring together Big Biopharma firm Merck & Co. (known as MSD outside North America), bioprocessing vendor Repligen, Massachusetts Life Sciences Center, and the University of Massachusetts Medical School. It is one of 22 projects recently announced by the…
Phacilitate: Cell & gene industry flocks to Miami
The cell and gene therapy industry congregated in Miami to discuss supply chain strategies, regulatory rationale and the high manufacturing costs of advanced therapies. BioProcess Insider attended the Phacilitate Leaders World Summit, co-located with the World Stem Cell Summit, in Miami, Florida last week. The conference reflected on the first full year where three advanced therapies – Kymriah, Yescarta, and Luxturna – proved themselves on the commercial stage, heralding in a new frontier for regenerative medicines. But industry quickly rose above…