Driving Bioprocessing Efficiency Case studies in process intensification and continuous processing

Charles L. Cooney, the MIT Robert T. Haslam Professor of Chemical and Biochemical Engineering in the Department of Chemical Engineering is also the Faculty Director of the Deshpande Center for Technological Innovation. Prof. Cooney’s research and teaching interests span a range of topics in biochemical engineering and pharmaceutical manufacturing. He has published over 250 research papers, over 25 patents and co-authored or edited 5 books including Development of Sustainable Bioprocesses: Modeling and Assessment. His research interests include manufacturing in the pharmaceutical, biotech and biofuels industries, bioprocess design, operation and control, and processing of pharmaceutical powders and technological innovation strategy.

Transformative upstream cell culture technologies from Repligen will be reviewed through case studies and noteworthy industry trends. The awardwinning ATF System cell separation device enables process intensification and continuous processing, while allowing for smaller bioreactors and smaller facilities that lend themselves to single-use facilities in more regions. Media plays a key role in perfusion processes, the leading application for ATF, where addition of key cell culture ingredients, including the industry-standard LONG®R3 IGF-I cell culture supplement, boosts productivity by increasing cell density and titer because it is 200 times more potent than insulin.

Massimo Morbidelli is Professor of Chemical Reaction Engineering at the Institute for Chemical and Bioengineering at ETH Zurich (Switzerland). His main research interests are in Chemical Reaction Engineering, polymer reactions and reaction-separation processes based on continuous chromatography. Thomas Villiger joined ETH Zurich in 2006 and graduated with a master degree in Chemical and Bioengineering in 2010. After working in the Bioprocess Development Department of Novartis Pharma AG in Basel, he rejoined the Morbidelli Group in 2011, where he works on an experimental and
mathematical framework to control protein N-linked glycosylation.

Morten Munk has over 25 years of industry experience in biopharmaceutical development and manufacturing and is a globally recognised technical expert in the field. He has authored or co-authored a number of technical articles and guidelines. Moreover, his technology expertise coupled with his thorough business understanding, means that he is frequently invited to give scientific and technical presentations at international conferences. In addition, he is active in international industry organisations, including ISPE and PDA, where he has formed part of the scientific committee for various international conferences.

Dr. de Jongh has significant experience in the pharmaceutical industry in molecular biology; cell line development; project management; upstream process development; process scale-up; and process transfer to cGMP manufacturing. He was instrumental in the development of the proprietary expression vector system Express2ion Biotechnologies was founded on. Dr. Poulsen completed his PhD at DTU, on a project focused on regulatory mechanisms in the traditional cell factory Aspergillus niger. At Expres²ion Biotechnologies, he focuses on upstream process development for recombinant protein production with the Expres2 Drosophila S2 cells-based platform.

Case studies will be presented to compare the different manufacturing strategies, which can be employed in the chromatography step, to meet the increasing purification demands of higher upstream titers and perfusion bioreactor processes. Short term, the effective deployment of pre-packed columns and cost effective Protein A is shown to increase overall facility flexibility while reducing costs, GMP suite time, and labor requirements. Longer term, the adoption of multi-column chromatography can be integrated with enabling technologies like pre-packed columns to further advance process time and cost reductions.

Dr. Hitchcock has over 30 years of experience in the large-scale manufacture of biopharmaceuticals. Tony has held positions in the Blood Products Laboratory (Elstree) and at Zeneca Pharmaceuticals in the protein process development department. As a founding staff member of Cobra Tony has been responsible for the development of much of Cobra’s manufacturing technologies in the field of DNA and virus production. He has held a number of senior roles, managing both manufacturing and development functions within the company, working on over 40 programmes for the development of novel therapeutic products including protein, recombinant virus (such as Ovine and Human Adenovirus and HSV), bacteriophage and plasmid DNA products. His current role is based on the development and introduction of new technologies into the company in both the UK and Sweden and to provide technical support to commercial and operational groups for new and on-going customer programme.

Dr. Stefan R. Schmidt currently serves as Vice President at Rentschler Biotechnology. Previously he held the CSO position at ERA Biotech in Barcelona, directing the company’s R&D efforts focusing on fusion peptides. Prior to that he worked at AstraZeneca in Sweden where he managed the unit of Protein Sciences as Associate Director. Before moving to Sweden he established and led protein biochemistry teams for Connex GmbH and GPCBiotech in Munich, Germany. In the last 10 years he worked intensively with fusion proteins, just recently editing and authoring the first comprehensive book on that topic. He holds a PhD in Biochemistry and a MBA in Marketing.

Dr. Lenz is a Senior Scientist for Downstream Processing in Bayer Pharma AG - Global Biological Development in Wuppertal focused on process development and clinical manufacturing. He joined Bayer in 1988 and worked as Organic Chemist in the Bayer Central Research for different projects dealing with Natural Chemistry (Isolation and Structure Elucidation of Natural Substances and Synthesis of Natural Secondary Metabolites) in order to explore new lead structures for crop protection and pharmaceutical indications. He obtained his Ph.D. in Organic Chemistry with focus on Natural Chemistry: Isolation and Structure Elucidation of Secondary Metabolites and Synthesis of Natural Secondary Metabolites from University of Münster “Westfälische Wilhelms-Universität”.