Friday, July 26, 2019 Daily Archives

Garbage in, garbage out: Raw material quality crucial for cell & gene therapies

Cell and gene therapy makers have suffered manufacturing setbacks, but experts working in the supply chain say ensuring high quality raw material is the key to success. Manufacturing issues have plagued the few advanced therapies to have made it to the market. Dendreon’s Provenge (sipuleucel-T) suffered from high complexity of manufacturing and administration, Novartis’ Kymriah (tisagenlecleucel) saw some variability in its product specifications, and – most recently – Bluebird Bio has been accused of lacking manufacturing readiness for its recently…

Merck builds up Gardasil network again with $680m NC injection

Merck & Co. will build a 225,000 square-foot facility in Durham to support production of its HPV vaccine Gardasil, creating 400 jobs. Merck will report its second quarter 2019 results on July 30, but for the previous quarter the firm saw a 31% year-on-year increase in sales of its human papillomavirus (HPV) vaccines Gardasil and Gardasil 9, which pulled in sales of $838 million (€752 million). Adam Schechter, Merck’s president of Global Human Health, said last year that his firm…