Managing Biologics Process Analytical Technology in Pfizer
12th March 2019 | 10.00 am EST | Keith Davis, Principle Scientist at Pfizer |BOOK FREE SEAT
Coordinating PAT between development and manufacturing organizations is always challenging. When there are multiple development sites and numerous manufacturing sites, this becomes especially challenging. In order to help manage this in an efficient manner, we have established a PAT SME network with representation from the Manufacturing and the Development organizations. I will briefly introduce how this team facilitates PAT activities and attempts to add value to both organizations.
Presented by Keith Davis, the Principal Scientist at Pfizer
Keith graduated from Purdue University with a Bachelor’s in Chemistry in 1996. After a short stint in Process Development, he started his career in protein process development analytical at Monsanto in 1998. There he was responsible for method development, HPLC maintenance and the maintenance of the online LC in Monsanto’s protein pilot facility. Keith’s responsibilities included redesigning, optimizing and eventually validating three parallel online HPLC systems. That controlled the collection endpoints of three parallel IEX column elutions in a new protein manufacturing facility. After transitioning to Pfizer in 2004, he focused on developing the analytical support strategy for the process development of biotherapeutics. He has served as the analytical Point of Contact for multiple BioConjugation projects as well as E. coli, CHO and bacterially expressed proteins, enzymes and polysaccharides. Keith is currently the Biotherapeutics Pharm Sci PAT lead for Biologics. His responsibilities include harmonizing the diverse needs of Pfizer’s Biotherapeutics Research and Development groups with the current, and future, capabilities of their commercial manufacturing organization.