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Scaling Up & Down With Optimized Bioreactors Speaker Biographies

2013 Archived Content

Beth Junker, Ph.D., Senior Scientific Director, BioProcess Development, Merck Research Laboratories

Beth Junker is currently Senior Scientific Director in the BioProcess Development group at Merck Research Laboratories. She has 23 years experience in the pharmaceutical industry in process development for natural products, therapeutic proteins, and vaccines. Previously she was responsible for non-GMP laboratory and pilot scale bioprocess operation areas, as well as rapid production of reagent proteins. Currently, she is responsible for Quality-by-Design for both process and analytical method development, knowledge management, operational excellence, as well as safety and environmental compliance, in the bioprocess area. She has completed her Six Sigma black belt, master black belt, and Change Execution agent 1 certifications. She received her Bachelor of Science in Chemical Engineering from Princeton University and PhD in Chemical Engineering from the Massachusetts Institute of Technology.

René Brecht, Ph.D., Vice President, Process Science & Manufacturing, ProBioGen AG

René Brecht joined ProBioGen in 2002 and currently is Vice President of Process Science and Manufacturing. He is responsible for both process development for recombinant proteins, antibodies and fusion proteins, as well as cGMP manufacturing of clinical material. His major process science focus is on product and process specific glycosylation issues and product consistency of sophisticated fed batch and perfusion processes. As project head, he takes responsibility for the successful realisation of the CMC part of customers’ drug development. Prior to joining ProBioGen, René held a position as Research Scientist at the University of Leipzig. He was responsible for pre-clinical and GMP process development of monoclonal antibodies and antibody fragments for therapeutic and diagnostic purposes.
He received his PhD in Pharmaceutical Chemistry from the University of Marburg on naturally occurring anticancer compounds.

Stefan Junne, Ph.D., Group Leader, Process and Systems Biotechnology, Chair, Bioprocess Engineering, Institute of Biotechnology, Technische Universität Berlin

Stefan Junne is working as a group leader at the chair of Bioprocess Engineering at TU Berlin, which is guided by Prof. Peter Neubauer. He holds a degree in chemical engineering and finalized his dissertation in the area of metabolic flux analysis and modeling. In recent years, his work is focusing on the integration of engineering and biotechnological approaches for a consistent bioprocess development. Main activities are the adoption of innovative (multi-position) sensor approaches and the combination of resulting on line measurements with metabolomics to elucidate inhomogeneities in industrial scale aerobic and anaerobic fed-batch processes and their impact on process performance. A special emphasis is put on the integration of methods to quantify cell-physiologic parameters at line. The knowledge gained is used to design and apply scale-down reactors where these gradients are already considered at an early stage of process development. In situ feeding strategies are applied to achieve fed-batch conditions already at the microtiter plate scale, ensuring process-relevant conditions. Kinetic process models and metabolic flux analyses are considered for (model-based) experimental design approaches. Strain selection and engineering as well as process design is tailored to the industrial application. Finally, software sensors are developed in scale-down reactors. The resulting process analytical tools should be ready-to-use in the industrial scale and lead to a more robust process performance and accelerated scale-up.

Aurore Lahille, Ph.D., Specialist, New Technologies and Manufacturing Support, Merck Serono

Aurore Lahille started as an intern at Merck Biodevelopment. She worked on scale-down models of manufacturing bioreactors. She was hired in 2005 as USP new technologies engineer and became new technology and manufacturing support specialist in 2009. She presented and published assessment studies of pilot scale disposable bioreactors in 2010. Aurore is USP process development and new technology manager since last July.

Krist V. Gernaey, Ph.D., Associate Professor, Center for Process Engineering and Technology (PROCESS), Department of Chemical and Biochemical Engineering, Technical University of Denmark

From 1997 to 2005 Krist’s research work was entirely focused on modelling, simulation and control of wastewater systems. In that period, he occupied postdoctoral fellow positions at Universiteit Gent (Belgium), at École Polytechnique de Montréal (Quebec, Canada), at the Technical University of Denmark (DTU) (Denmark) and at Lund University (Sweden).
He occupies a position as Associate Professor at the Department of Chemical and Biochemical Engineering at DTU since 2005, and his research focus has shifted to characterizing and optimizing processes at micro-, lab, pilot and full scale, using a combination of advanced process modelling and simulation tools supported by a substantial amount of experimental work at different scales. During the past years, Krist has worked with fermentation processes, biocatalytic processes, biofuel production processes, organic synthesis based pharmaceutical production and food production processes. Important topics in his current work are; (1) Process Analytical Technology (PAT) where his team applies mechanistic models and simulation tools for building up process knowledge, along with data-driven modelling and chemometric methods for process monitoring and control applications; (2) moving from batch to continuous production systems, currently applied to pharmaceutical and biocatalytic production processes; (3) development of novel intensified reactor types, including microreactors for fermentation, biocatalysis and organic synthesis; (4) development of modelling and model analysis tools, and application of such tools to different processes, including uncertainty and sensitivity analysis methods, computational fluid dynamics (CFD), population balance models (PBM) etc.

Kristie R. Apgar, Research Chemical Engineer, Bioprocess Clinical Manufacturing Technology, Merck Research Labs, Merck & Co., Inc.

Kristie received her B.S. in Chemical Engineering from the Pennsylvania State University. She started at Merck in 2002 in the Recombinant Vaccine Technology & Engineering group where she was a member of the startup team for the purification of Gardasil®. She performed Factory Acceptance Testing, Site Acceptance Testing, through Process Validation (PV) lots for the buffer area and was a member of the ultrafiltration team for the PV of the purification lots. For the stability lots and 2nd generation PV lots, she was the lead for the chromatography steps. She led the Merck Manufacturing Division PV demonstration for the final type as well as the optimized purification process demonstration for one type prior to moving to the Merck Research Laboratories Pilot Plant in 2008. There she has led several chromatography steps in multiple different product batches as well as being the Area Campaign Lead (ACL) for two different programs. She also has been the Sanitization / Cleaning lead for the Buffer Distribution capital project and startup.

E. Todd Sorensen, M.S., Development Associate 4, Alexion Pharmaceuticals, Inc.

E. Todd Sorensen is a Development Associate 4 at Alexion Pharmaceuticals in the Upstream Development Department. In this capacity, he has led several developmental initiatives relating to current and future product lines. Prior to this position, he worked briefly for CuraGen Corporation, and for Diosynth Biotechnologies (now called Fujifilm Diosynth Biotechnologies). During his working career he has had the privilege to work on over 30 different biopharmaceutical candidates expressed in many types of cells.
He received a B.S. in Chemical Engineering from Rensselaer Polytechnic Institute. He received a M.S. in Chemical Engineering from Georgia Institute of Technology under the guidance of Dr. Mary Rezac. He is the co-author of numerous journal articles and other publications. In addition, he is a co-inventor on a distinct patents relating to cell culture process control.

Blanca Lain, Ph.D., Senior Scientist, Downstream Process Development, Percivia LLC

Blanca Lain is a senior scientist in the downstream development group at Percivia. Her group developed platform technologies for the purification and analysis of recombinant molecules produced in the PER.C6® cell line. Before that she worked at Syntonix, now Biogen Haemophilia, where she developed purification processes enabling preclinical and early clinical studies. One of these molecules, a long lasting Factor IX, entered registration clinical trials after encouraging performance in Phase I/II trials.

Sascha Beutel, Ph.D., Scientific Advisor and Substitute Director, Institute for Technical Chemistry, Leibniz University of Hannover

Sascha Beutel has performed his PhD under supervision of Prof. Thomas Scheper in Hannover in the field of enzymatic removal of surface-bound protein-layers and finished in 2000. After a short Postdoc he was for 4 years scientific leader of the Competence center for Functional food applications in Lower Saxony and coordinator of a Bachelor study-course for Life Science at the University of Hannover.
 Since 2006 he is head of the Central unit for the disposal of sensible waste as well as Commissioner for the transport of dangerous goods at the Leibniz University of Hannover and Scientific advisor in the Institute for Technical Chemistry. Since 2010 he is also substitute director of the Institute.

Janani Ravindhar, M.S., Engineer I, Manufacturing Sciences, Biogen Idec

Janani Ravindhar is an Engineer specializing in purification in the Manufacturing Sciences group at Biogen Idec.  Janani received her Masters degree in Engineering from Columbia University, New York and Bachelors in Industrial Biotechnology from Anna University, India.  In 2011, she joined the Manufacturing Sciences group of Biogen Idec in Cambridge.  Since then, she has been involved in technology transfer activities with a focus on downstream processing.

Sofie Goetschalckx, M.S., Manufacturing Cell Culture Science Lead, Technology, Genzyme Belgium

I joined Pharming in 2000 as part of the R&D organization. Shortly after Genzyme’s acquisition, I became jointly responsible to start up a cell culture team and to equip the new laboratories. I have played an important role in the transfer, scale up and validation of the cell culture processes for Myozyme and Campath. My team has developed and qualified small-scale models for various larg- scale cell culture processes and provides Global support to Genzyme’s Manufacturing Sites. I hold a Masters Degree of Biochemistry from the University of Antwerp.


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