Plenary Keynote Session
Wednesday, August 23 (4:45 - 6:00pm)
4:45 Chairperson’s Remarks
John Sterling, M.A., Editor-in-Chief,
Genetic Engineering & Biotechnology News
4:50 Protein Aggregation and Oxidation during Processing
Jean-René Authelin, Ph.D., Global Head, Pharmaceutical Engineering, Sanofi
Proteins are known to be sensitive to many stresses, including oxidation and shear stress, leading to potentially immunogenic aggregates. In this talk, we will present theoretical aspects together with real-life industrial examples illustrating the possible traps we may find in the fill & finish processing. We will, as well, propose the experiments that need to be performed in order to understand and predict the risk and the practical industrial solutions to implement solutions accordingly.
5:25 Practical, Proven and Innovative Solutions for Today’s Manufacturing Challenges
Thomas Seewoester, Ph.D., Executive Director and Plant Manager, Amgen Rhode Island
Amgen’s Rhode Island facility is among the largest drug substance production facilities in the world and is a cornerstone in Amgen’s global production network. We will share some practical, proven and innovative solutions to achieve reliable, efficient and agile multi-product and multi-process manufacturing operations aimed at providing uninterrupted global supply.
6:00 Close of Plenary Session
Plenary Speaker Biographies
Jean René Authelin, Ph.D., Global Head of Pharmaceutical Engineering, Sanofi-Aventis
Jean René Authelin has an Engineering degree in Chemical Engineering from ENSIC (Nancy France), and a PhD from The Institut National Polytechnique de Lorraine (France). He joined Rhone Poulenc in 1988 as a Chemical Engineer. In the 90’s, he founded the Physical Quality function, dedicated to the API crystallization, drying, polymorphism for which he was for 10 years Global Head in Rhone Poulenc Rorer, Aventis and finally Sanofi. In 1988, JR Authelin was nominated Global Head of Pharmaceutical Engineering. Domains of interest of JRA include: thermodynamics of hydrates, drug polymorphism, amorphous solids physics, drug stability, crystallization, nanoparticles engineering and processing, drying, milling; spray drying, fluid bed granulation, roller compaction, freeze drying. Jean René Authelin is the author or co-author of 20 publications or book chapters and the co-inventor of 9 patents.
Thomas Seewoester, Ph.D., Executive Director and Plant Manager, Amgen Rhode Island
Thomas is a leader in Amgen’s Operations organization and Plant Manager of Amgen’s Rhode Island facility. Prior to his current role he was head of Drug Product Supply and Drug Substance Supply in Thousand Oaks with responsibilities to provide global clinical supply out of two drug substance plants, a drug product plant, a device assembly and packaging plant and a small molecule API plant. In those plants Thomas and his teams have successfully matured new operations technologies for their successful commercialization and network-wide deployment. His plant teams received twice awards for being the most improved plants. Thomas champions a culture of safety, global teamwork, operational excellence and lean manufacturing in order to generate product and data most efficiently while continuously improving the operation. Throughout his 25 years of industrial bioprocessing experience in Process Development and Manufacturing, Thomas and his various teams have developed over 40 clinical and commercial processes and created knowledge to commercialize some of the most successful bio-therapeutics. Thomas received a Ph.D. from the Institute for Cell Culture Technology, Germany and completed a 2-year postdoc program.
Videos from Past Plenary Keynote Sessions: