The biopharmaceutical industry is experiencing tremendous change, challenges, and opportunities. These have been brought on by the advent of single use technologies, high titer processes, challenges to tradition by biosimilars, and new tools such as QbD/PAT. These innovations are changing the way biopharmaceuticals are developed, produced and characterized which can positively impact process development capabilities, timelines, cost structures, and even the entire manufacturing strategy. This session invites papers on the development and application of single use technologies in the upstream and downstream areas, advances in bioprocess monitoring and control, new approaches to harvest and downstream processes including considerations of high titer processing, and alternative manufacturing schemes such as continuous processes to bring about more efficient and cost effective therapeutics.

Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture

Pharmaceuticals (15b)