This webcast features: Kristen DeVito, Global Director, Clinical Supply Services, Catalent Pharma Solutions Biologic clinical trials can be complex with many factors to consider. Understanding your specific needs and developing a plan early on during drug development can reduce delays and missteps during clinical trials. This presentation will discuss: How protocol design can impact clinical supply strategy Which clinical supply variables are most likely to be on the critical path Proactive steps to ensure continuity of supply and reduce the…
Tuesday, February 19, 2019 Daily Archives
AGC Bio ‘CHOsen’ to make Interleukin-15 inhibitor for Serono spin-off
CDMO AGC Biologics will develop the process and manufacture Calypso’s CALY-002, a humanized monoclonal antibody manufactured in a CHO cell line, from its site in Denmark. Calypso Biotech, a spin-off from Merck Serono, has selected contract development and manufacturing organization (CDMO) AGC Biologics for the process development and cGMP production of its lead candidate CALY-002. The work will be undertaken at AGC Bio’s site in Copenhagen, Denmark. Financials of the deal have not been divulged, but Calypso’s CEO Alain Vicari…
AveXis on gene therapies: ‘We’ll get better at this and it will get cheaper’
AveXis has spent about $1 billion in preparing to launch its spinal muscular atrophy (SMA) gene therapy later this year. The Novartis subsidiary is pumping a further $60 million into its North Carolina facility. In May 2018, Gene therapy firm AveXis announced a $55 million (€49 million) investment to establish a manufacturing center in Durham County, North Carolina. Nine months on, and AveXis is doubling down on the site, revealing plans to invest a further $60 million and create 200…