Year: 2016-17

Company: Thermo Fisher Scientific

Liaison(s): Peter Bell, Jim Bylund, Michael Goodwin

Thermo Fisher Scientific, Inc. is a world leader in providing lab equipment, rapid and accurate specialty diagnostics, and innovative analytical instruments for use in research, clinical, and applied science in over 50 different countries. Within applied science, Thermo Fisher Scientific offers a multitude of products and services for bioproduction, including bioreactors, host cell lines, chromatography resins, media kits, analytical sensors and other single-use technologies to assist in upstream and downstream drug development. Thermo Fisher’s mission is to enable customers to make the world healthier, cleaner, and safer. In order to assist their customers in these endeavors, Thermo Fisher is devoted to developing and offering the most innovative and modern technologies to assist in bioproduction. Process Analytical Technology ( PAT ) is used to design, analyze, and control manufacturing processes. It is used to monitor critical process parameters ( CPPs ) which affect critical quality attributes ( CQAs ) of biopharmaceuticals. With a growing trend towards single-use technology, as well as continuous manufacturing, PAT will be beneficial to increase process understanding and process control to ensure the production of high quality biopharmaceuticals. The KGI TMP was tasked to assess the implementation of PAT within the biopharmaceutical industry, as well as identifying current and emerging PATs. Primary and secondary research was conducted through interviews and literature reviews in order to assess trends and gaps in PATs and its implementation. By the end of the project, an assessment of PAT usage within the biopharmaceutical industry, as well as recommendations of emerging technologies, will be presented to Thermo Fisher.