Despite their potential to increase the efficiency of the healthcare system, autologous cell therapy treatments present significant challenges to most companies when it comes to development and manufacturing. Innovators across the industry who want to see personalized medicine, such as autologous cell therapies, reach its full potential are focusing on developing technology that can create a realistic business model for these treatments.
Since 1984 when U.S. regulations favoring adoption of generics were enacted, the global generics market has grown to account for roughly 38% of global pharmaceutical spending and this portion is expected to increase to 43% in the next five years.1 Will biosimilars follow the generics trajectory in the next few decades?
In June 2016, Alvotech opened their new biosimilar manufacturing facility in Reykjavik, Iceland, using best of breed solutions from leading Life Science vendors. The key directive for Alvotech was to create a flexible, agile process which could adapt and be used for any conceivable process. The result: A high yield disposable fermentation and downstream process, with a fill-and-finish line for vials and prefilled syringes, tied together with a complete, end-to-end upstream/downstream automation and Manufacturing Execution System.
A question and answer session with Barbara Paldus, Ph.D., Vice President and General Manager Finesse, part of Thermo Fisher Scientific
A problem with traditional mAb manufacturing is that there are so many potential entry points for microbial contamination. There are, however, ways to shut the door on contamination.
Manufacturing biologicals is tricky. A major concern is the risk of microbial contamination, jeopardizing product safety and causing high costs. But there are solutions for decreasing the risks.
GE Healthcare has compiled this ebook, which includes information on some of the latest SUT trends in the world of bioprocessing.
Complex CMO networks are expensive and require many resources to manage. Plus, they prevent purchasing and operating at scale. Yet, the process of consolidating CMOs is daunting.
Immunotherapies are being touted—both in scientific literature and the general media—as the most promising advances in cancer treatment in decades.
This application note describes mixing and heating-cooling characterization data for the Xcellerex XDM/ XDUO 500 single-use mixer. A design of experiments (DoE) approach to liquid-liquid mixing was successfully applied to establish a statistical model to predict the mixing time throughout the working range.