Securing the clinical supply chain comes down to the notion of ‘compliance’, which is transitioning from a ‘nice to have’ to a ‘need to have,’ says Cryoport.
Johnson & Johnson has unveiled a vaccine facility in Leiden, the Netherlands, which will focus on R&D, technological development, and large-scale production of vaccines for late-stage clinical trials.
Novartis is working with the US FDA to solve a manufacturing issue affecting Kymriah, identified as ‘variability in its commercial specifications’, says CEO.
Novasep has launched a downstream processing tool that combines batch and continuous chromatography for monoclonal antibodies, recombinant proteins and blood factors.
Ultragenyx Pharmaceutical is transferring fill/finish activities for Mepsevvi from Rentschler Biopharma’s facility in Germany, to Rentschler Fill Solutions in Austria.
