CDMO Vibalogics plans for its late-phase clinical and commercial manufacturing facility to be operational in 2021. Vibalogics, a contract development and manufacturing organization (CDMO) specializing in oncolytic viruses, viral vector vaccines and viral vector gene therapy products, has entered the ‘Phase I’ stage of the investment into the site. The three-year project will see a 110,000-square-foot facility constructed near Boston, Massachusetts, which will be operational in the second half of 2021. This investment follows on from the German company’s expansion…
Tuesday, November 17, 2020 Daily Archives
Seqirus injects $580m into Australian cell-based flu vaccine plant
The site in Melbourne will be the first cell-based manufacturing facility in the southern hemisphere to produce flu vaccines, along with Seqirus’ adjuvant MF59 and Australian antivenoms. Seqirus has been making seasonal flu jabs since 2015 after parent company CSL Limited acquired Novartis’ global influenza vaccine business. The firm has increasingly moved away from egg-based vaccine production towards cell-based manufacturing and has scaled up its capacity to meet demand. The latest investment announced this week is a plan to spend…
CMO deficiencies land Sanofi with CRL for sutimlimab
Sanofi says it is working with its third-party manufacturer and the US FDA to resolve issues raised in the Complete Response Letter. French pharma giant Sanofi has suffered a setback after sutimlimab, its investigational monoclonal antibody for the treatment of hemolysis in adults with cold agglutinin disease, received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA). The firm stated the letter refers to “certain deficiencies identified by the agency during a pre-license inspection of a…