Drug substance manufacturing only contributes around 5% on average to the total cost of a biologic says GE Healthcare’s Guenter Jagschies. Payors, patients and governments are increasingly looking to industry to justify the high prices of prescription drugs. As new immuno-oncology treatments are being launched with increasingly higher price tags and often the cost of producing these complex biotherapeutics. “This industry is not pricing based on cost, it is pricing based on perceived value,” Guenter Jagschies, senior director of strategic…

The adoption of viral vector technology in cell and gene therapy has led to six month waiting lists for multilayer culture vessels. Hyperstack vendor Corning says it will more than double its manufacturing capacity to deal with the demand. Despite being a registered brand owned by Corning Life Sciences, ‘hyperstack’ has become a common term to describe multilayer, scalable, and single-use culture flasks. They are used to produce viral vectors and gene therapies, and are in huge demand, according to…

Allogeneic cell therapies have greater commercial potential than autologous products, an industry survey finds. Respondents also believe there are a lack of third-party capabilities to make these new therapies. When Novartis’s Kymriah (tisagenlecleucel) received the regulatory thumbs up in August 2017, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb described regenerative medicines as being “no longer the stuff of science fiction.” The approval of Gilead/Kite’s Yescarta (axicabtagene ciloleucel) weeks later helped cement the safety and commercial potential of CAR-T…