Stream 4 - Speaker Bios
Cell Therapy Bioproduction
Fouad Atouf, Ph.D., Director, Biologics & Biotechnology, U.S. Pharmacopeial Convention
Fouad Atouf is Director of Biologics and Biotechnology at the United States Pharmacopeial Convention where he oversees the development of standards for biological medicines to be included in the USP-NF book of standards. Dr. Atouf served previously as USP’s regional champion for the Middle East and North Africa Region, where he supported programs aimed to enhance the understanding of regulations and standards in the registration of medicinal products. Prior to USP, Dr. Atouf worked at the U.S. National Institutes of Health; his work focused on the development of methods for the in vitro generation of pancreatic islets cells, as potential strategies of cell-based therapies for diabetes. Prior to that, Dr. Atouf was a fellow of the Howard Hughes Medical Institute, at the State University of New York, where he investigated some of the mechanisms involved in the development of neuronal cells. Dr. Atouf is the author of many publications and is frequently invited to speak at national and international scientific conferences. Dr. Atouf earned his Ph.D. in Cell Biology from the Pierre & Marie Curie University, Paris, France.
Veronique Chotteau, Ph.D., Principal Investigator, Cell Technology Group, School of Biotechnology, KTH, Royal Institute of Technology
Dr. Veronique Chotteau (M. Sc. Electrical Engineering (Université Libre de Bruxelles, Belgium), M. Sc. Molecular Biology and Biotechnology (Université Libre de Bruxelles, Belgium), Ph.D. Biotechnology/Automatic Control (Université Catholique de Louvain, Belgium)) has ≥ 25 years of experience in mammalian cell culture including ≥ 10 years in biopharmaceutical industry. Her expertise covers process development (perfusion, fed-batch, stem cell bioprocessing, small-, pilot- and commercial scale, GMP). V Chotteau has worked at Pharmacia Upjohn/Biovitrum, Stockholm, (nowadays Swedish Orphan Biovitrum) between 1996 and 2008 with different responsibilities: project manager for process development (e.g. recombinant factor VIII ReFacto®, antibody), CDMO business development support for the evaluation of new projects, head of pilot plant, expert in animal cell culture development (small, pilot and commercial size/GMP). In 2008, consequently to the retirement of Prof. Lena Häggström, formerly leading the animal cell cultivation activities, V Chotteau was offered to lead these activities, due to her expertise in cell culture and her industrial background. Since then, her group has focused on cell-based processes for biopharmaceutical production and on stem cell bioprocessing. In May 2013, V Chotteau became Coordinator of EU-FP7 project HESUB, nr. 601700. Her group has also performed/is performing several projects of perfusion process at high cell density, metabolic flux analysis and development of fed-batch process for biopharmaceutical production (two of these processes have been transferred to CMO for GMP production, of which one is in clinical phase III).
Anthony Davies, Ph.D., President, Dark Horse Consulting, Inc.
After training as a biochemist, chemical engineer and molecular biologist, Anthony Davies has worked in the cell and gene therapy field for some 20 years. Over this period he has held positions of increasing responsibility at companies including Onyx Pharmaceuticals, Geron Corporation and Capricor. He is now president of Dark Horse Consulting, a boutique practice focussed on CMC and product development issues in cell and gene therapy.
Robert J Deans, Ph.D., Exec VP of Regenerative Medicine, Athersys Inc
Dr. Deans is responsible for regenerative medicine technology development at Athersys Inc. and its European subsidiary, ReGenesys. Athersys is developing cell therapeutics based on adherent stem cells (MultiStem) isolated from adult bone marrow. Athersys has active Phase I and II clinical development activity in acute myocardial infarct, stroke, ulcerative colitis, and for adjunctive therapy of allogeneic bone marrow transplant. Dr. Deans is also chairman of the ISCT Commercialization Committee, co-Chair of the Science and Technology Committee of ARM, and serves on the ISSCR Clinical Translation Committee. Dr. Deans has more than 20 years of experience in stem cell therapeutics, having previously served at Osiris Therapeutics as VP of Research. Dr. Deans was previously Director of R&D at Baxter Healthcare, where he developed biological components of the Isolex300i hematopoietic stem cell purification platform. In addition, Dr. Deans served on the faculty at USC Medical School from 1984 to 1992. He holds degrees from MIT and the University of Michigan, and postdoctoral training in molecular immunology at UCLA.
Jasmin Kee, Ph.D., Head, Engineering, ReNeuron
Jasmin is the Head of Engineering at ReNeuron, a UK clinical-stage stem cell business developing novel therapies targeting areas of significant unmet medical need. She is responsible for the scale-up, automation and technology transfer of the flagship stem cell therapy candidate, CTX, which is currently in Phase II clinical trials for the treatment of patients left disabled by stroke and Phase I trials for treatment of critical limb ischaemia. In collaboration with the Welsh Government, Jasmin is the ReNeuron project lead for the design and build of a new manufacturing facility which will bring manufacturing in-house from contract manufacturers for later stage clinical trials and commercial supply. She is in the process of building an Engineering team that has a fundamental understanding of six sigma, QbD and lean manufacturing principles to enable the design and implementation of an operationally efficient manufacturing facility. She holds a Master of Mechanical Engineering degree from Loughborough University, UK and undertook an industrial PhD sponsored by cell therapy company Intercytex, UK. Jasmin has worked as a Process Engineer in multi-national, fast moving consumer goods companies for several years where she implemented process optimization and six sigma projects. She then moved to the USA to work for Organogenesis Inc, MA where she was responsible for scale-up and automation of the flagship product Apligraf®, expansion of the QC laboratories and design of a state-of-the-art manufacturing facility before returning to the UK.
Ohad Karnieli, Ph.D., MBA, Vice President, Development and Manufacturing, Pluristem Therapeutics, Israel
Dr. Ohad Karnieli earned his PhD in Biotechnology and genetic engineering from the Sackler School of medicine at Tel Aviv University. Furthermore, Dr. Karnieli earned an MBA from the graduate school of Management at the Haifa University. In his PhD, Dr. Karnieli developed insulin secreting cells from human mesenchymal stem cells using genetic modulations.
Prior to joining Pluristem, Dr. Karnieli served as the general manager of High Tech Lipids, an innovative IV nutrition company; the vice president of research and development in an innovative nano-biotechnology startup; and as the vice president, head of the Biomedical division at Goji solutions, where medical devices are developed using radio frequency technology. Dr. Karnieli is the founder of Karnieli Ltd., a leading molecular diagnostic and development lab.
Pranay D. Khare, Ph.D., Director, Cancer Immunotherapy and Gene Therapy cGMP Facility, Roger Williams Medical Center
Pranay Khare, PhD has sixteen years of experience in biologic discovery and their development to early stage clinical trials in immunotherapy and gene therapy field. Presently, Dr. Khare is the Director at Cancer Immunotherapy and Gene Therapy cGMP facility of Roger Williams Medical Center, Providence, RI. Dr. Khare is responsible for the genetic modification of T-cells with chimeric antigen receptor (CAR) for solid tumor clinical trials and bispecific antibody conjugated armed T-cells based clinical trials for solid tumors. Dr. Khare's primary role is to direct the clinical scientific collaborative studies, responsible for modified T cell manufacturing, quality assurance and quality control processes.
Dr. Khare’s educational background is viral immunology and always fascinated with T cell and their role in disease development and protection. After finishing his Ph.D. in T cell biology in dengue virus disease, Dr. Khare strengthen his understanding of T cell and their genetic modification process at Molecular Oncology Center at Fukuoka University, Japan and Molecular Medicine Department at Mayo Clinic, Rochester, MN, USA. Before moving to his current position he was Scientific Director at Neuroscience, Inc where he developed several T cell based clinical diagnostic tests for chronic diseases. Dr. Khare also has several patents on eukaryotic display technology that could be used to identify the novel receptors, ligands, biomarkers and antibodies. Through our his career Dr. Khare has received funding from the National Institute of Health (NIH), Susan G. Komen Breast Cancer Foundation, Leukemia Research Foundation, and other international funding agencies.
Bernd Leistler, Ph.D., Director, Development & Production, CellGenix GmH
Bernd Leistler, as Director of Development & Production at CellGenix GmbH, he is responsible for all products, including media and cytokines for ex vivo cell processing. He has a long track record as a protein specialist. Following his degree in chemistry he joined the Basel Biocenter for his dissertation on studies of structure, function, folding and assembly of oligomeric proteins. He continued these studies as a postgraduate researcher in Cambridge, UK. His professional carreer started at Pharmacia Diagnostics, a leading manufacturer of diagnostic autoantibody immunoassays. Dr. Leistler managed the Biotechnology Department as a corporate service unit for recombinant and conventional human autoantigens and allergens.
Gary C. du Moulin, Ph.D., M.P.H., former Senior Director, Quality Aseptic Control, Genzyme (A Sanofi Company)
Gary C. du Moulin, Ph.D., M.P.H. recently retired as Senior Director of Quality Aseptic Control for Genzyme (A Sanofi Company) where he participated in the development and execution of robust quality systems for Genzyme’s products including cell and tissue engineered therapeutics. Dr. du Moulin joined Genzyme in 1995 after working for six years developing quality systems for cellular therapies for the treatment of renal cell carcinoma. Prior to his industrial experience, he spent 15 years on the faculty of Harvard Medical School in the Department of Anaesthesia at Beth Israel Hospital. He has more than 150 publications in the areas of microbiology, epidemiology, and the regulation and quality control of living cells as a therapeutic modality. Dr. du Moulin received his B.S. in 1969 from Norwich University, an M.S. degree from Northeastern University, and M.P.H. and Ph. D. degrees from Boston University. Dr. du Moulin currently serves on U.S. Pharmacopoeia’s expert committee for Biological Analysis and formerly on the Gene Therapy, Cell Therapy, and Tissue Engineering Expert Committee and chaired the ad hoc advisory panel for fetal bovine serum. He serves on the editorial board of Regenerative Medicine and is RAC certified and past Chairman of the Editorial Board of the Regulatory Affairs Professionals Society Magazine, RAPS Focus and was appointed to the Grants Review Working Group of the California Institute for Regenerative Medicine. He is retired from the U.S. Army Reserve at the rank of Colonel after 38 years of service.
Brian Murphy, Ph.D., Director, Bioprocess Development, Celgene Cellular Therapies
Brian Murphy is currently Director of Bioprocess Development at Celgene Cellular Therapeutics in Warren, NJ. His group is responsible for developing, optimizing, and scaling up cell isolation, expansion, and formulation processes and for transferring these technologies to clinical and commercial GMP manufacturing facilities. Prior to joining Celgene in 2007, he worked in the Merck Manufacturing Division and provided engineering support for the plant start-up of the Biotechnology Manufacturing Center and for the manufacture of a recombinant vaccine. Upon returning to graduate school, he conducted thesis research on gene repair of mouse embryonic stem cells using single-stranded oligonucleotides. With great appreciation for both scientific research and commercial practicality, Brian is currently focused on the challenge of developing novel therapeutics and processes into commercial products. Brian holds a B.S. in Chemical Engineering from Cornell University, and a M.S./Ph.D. in Chemical and Biomolecular Engineering from the University of Pennsylvania.
Knut Niss, Ph.D., CSO Office, Cell & Gene Therapy Unit, Novartis Pharmaceuticals
Dr. Niss completed his doctoral work at the Max-Delbrueck Center in Berlin, Germany working on developmental pathways involved in leukemic cell transformation. He holds a PhD in molecular biology and a master’s degree in biology. Following his doctorate work Dr. Niss performed his postdoctoral studies at Children’s Hospital and the Dana Farber Cancer Institute in Boston. Here, he analyzed genes involved in hematopoietic stem cell maintenance and differentiation. Following his postdoctoral work, Dr. Niss joined Pfizer’s Immunology group first in Connecticut and later in St. Louis to serve as a team leader for hematopoiesis. In this role, he oversaw the implementation of various small molecule and biologics programs into Pfizer’s preclinical pipeline. Following this, Dr. Niss was appointed as the research team leader for adult stem cells in Pfizer’s Regenerative Medicine unit in Cambridge, MA. Recently, Dr. Niss was a Senior R&D program manager for EMD Millipore’s Stem Cell Initiative. There, he led the efforts on large scale stem cell expansion and downstream processing. Under his supervision, his group was the first to show stem scale expansion processes at the 50L scale. In 2013, Dr. Niss moved his career to Novartis Pharmaceuticals in Morris Plains, NJ where he served initially as a senior technical project leader for Novartis’ cell therapy programs. More recently, Dr. Niss moved to the Chief Scientific Office for Novartis’ Cell and Gene Therapy Unit.
Elizabeth Read, MD, Principal, EJ Read Consulting LLC.
Dr. Elizabeth Read is an independent consultant specializing in development of cell therapy/regenerative medicine products. She works with academic and industry clients on projects involving CMC/IND/BLA development and regulatory submissions for novel cellular therapies; clinical trials; cell source collection, banking, and qualification; ancillary reagent development; automated cell processing methods; manufacturing process development; and quality/regulatory compliance issues. Clinically trained in Internal Medicine, Hematology, Oncology, and Blood Banking/Transfusion Medicine, Dr. Read has led cell therapy programs in government, nonprofit, and industry organizations. From 1995-2006, she served as Section Chief and Medical Director of the Cell Therapy Core Facility at the NIH Clinical Center (Bethesda, MD, USA). She has served on numerous advisory and standard-setting committees focused on quality, safety, and efficacy of blood products and cell, tissue, and gene therapies, including AABB, the US DHHS/HRSA Advisory Council for Blood Stem Cell Transplantation, and the US Pharmacopeia/Biologics & Biotechnology.
Jonathan Rubin, Ph.D., Process Development Scientist, Process Development and Manufacturing Sciences, Janssen R&D
Dr. Jonathan Rubin is currently the downstream process development lead for a cell therapy product at Janssen R&D, a Johnson and Johnson company. He previously worked as a viral process development scientist with the Department of Homeland Security and Merial, a Sanofi company. Dr. Rubin earned his Ph.D. from the Georgia Institute of Technology in Chemical and Biomolecular engineering in 2013.
Ulrike Verzetnitsch, MSc., CTO, GMP Operations, apceth GmbH & Co.
After finishing my studies in biochemistry and chemical engineering in 2000 I started working at Baxter in Vienna. Within Baxter I was responsible for final container production of aseptic blood plasma products, vaccines and recombinants of commercial and clinical products. In 2010 I joined Takeda where I was responsible for manufacturing of aseptic/sterile liquid and lyophilized as well as non-sterile liquid and semi-solid commercial products. In 2015 I joined Apceth as CTO being responsible for all GMP operation activities.
Continuous Processing in Biopharm Manufacturing
Jean-Marc Bielser, MSc. (Eng), Assistant Scientist, Biotech Process Sciences, Merck Serono
Jean-Marc Bielser obtained his degree in chemical engineering and biotechnology at EPFL in 2012. He joined EMD Serono in September 2013 as an assistant scientist in the upstream process development team. In this group he was in charge of running high throughput experiment for media optimization (DoE) and clone screening. He was then integrated in the new technology development group that is working on continuous bioprocesses, and started to evaluate perfusion processes.
Veronique Chotteau, Ph.D., Principal Investigator, Cell Technology Group, School of Biotechnology, KTH, Royal Institute of Technology
Dr. Veronique Chotteau (M. Sc. Electrical Engineering (Université Libre de Bruxelles, Belgium), M. Sc. Molecular Biology and Biotechnology (Université Libre de Bruxelles, Belgium), Ph.D. Biotechnology/Automatic Control (Université Catholique de Louvain, Belgium))
has ≥ 25 years of experience in mammalian cell culture including ≥ 10 years in biopharmaceutical industry. Her expertise covers process development (perfusion, fed-batch, stem cell bioprocessing, small-, pilot- and commercial scale, GMP). V Chotteau has worked at Pharmacia Upjohn/Biovitrum, Stockholm, (nowadays Swedish Orphan Biovitrum) between 1996 and 2008 with different responsibilities: project manager for process development (e.g. recombinant factor VIII ReFacto®, antibody), CDMO business development support for the evaluation of new projects, head of pilot plant, expert in animal cell culture development (small, pilot and commercial size/GMP). In 2008, consequently to the retirement of Prof. Lena Häggström, formerly leading the animal cell cultivation activities, V Chotteau was offered to lead these activities, due to her expertise in cell culture and her industrial background. Since then, her group has focused on cell-based processes for biopharmaceutical production and on stem cell bioprocessing. In May 2013, V Chotteau became Coordinator of EU-FP7 project HESUB, nr. 601700. Her group has also performed/is performing several projects of perfusion process at high cell density, metabolic flux analysis and development of fed-batch process for biopharmaceutical production (two of these processes have been transferred to CMO for GMP production, of which one is in clinical phase III).
Jeff Johnson, Ph.D., New Technology Lead and Director, Global Engineering Services, Merck & Co., Inc.
Jeff Johnson is currently the New Technology Lead and Director, Global Engineering Services at Merck & Co., Inc., where he is responsible for the assessment of new manufacturing technology for Merck's vaccine, biologics, and sterile manufacturing processes. He is also the co-leader of Merck's Single Use Technology initiative. Prior roles include Director of BioProcess Engineering, responsible for business case and concept development for new vaccine and biologics capital projects, and Director of Network Management for Therapeutic Protein Commercialization. Prior to Merck, he worked for Genzyme Corporation, Raytheon Engineers, and ARCO Chemical Co. He holds a BS in Chemical Engineering from the University of Rochester, a MS in Chemical Engineering from the University of Pennsylvania, and a Certificate in Biotechnology from Tufts University.
Robert Kozak, Ph.D., Senior Regulatory Science Advisor, Global Regulatory Affairs, Bayer Healthcare
Dr. Kozak is Senior Regulatory Science Advisor in Global Regulatory Affairs. He has been with Bayer for over 20 years focused on CMC issues for Biotech products. Prior to joining Bayer he was a member of the National Cancer Institute and spent 5 years with CBER, FDA as a tenured Biotech product reviewer, cell substrate expert and Branch Chief of Immunoconjugate MAbs.
Dr.-Ing. Kathleen Mihlbachler, Global Director of Separations Development, LEWA Process Technologies
Dr. Mihlbachler has worked in the field of process chromatography for almost 20 years. Currently, she is the Global Director of Separations Development at LEWA Process Technologies. She is responsible for the development of separation technologies for synthetic and biological molecules, in particular for continuous processing. Prior to joining, Dr. Mihlbachler was a consultant to LEWA-NIKKISO where she has supported the technical transfer of process chromatographic technology and consulted in customer projects. Dr. Mihlbachler worked 10 years as Sr. Researcher in pharmaceutical industry. She was involved in the development, scale-up and manufacturing of purification/separation processes for chiral and non-chiral compounds, peptides and proteins, in particular to implement continuous processes, at BMS, Eli Lilly and Pfizer. From 2011 to 2013, Dr. Mihlbachler has taught undergraduate courses for chemical and biomedical students at New Jersey Institute of Technology.
Massimo Morbidelli, Ph.D., Professor, Institute for Chemical and Bioengineering, Department of Chemistry and Applied Biosciences, ETH Zürich
Massimo Morbidelli received his Laurea in Chemical Engineering at the Politecnico di Milano in 1977, and his PhD in Chemical Engineering at the University of Notre Dame in 1986. After his first appointments as professor at the University of Cagliari (Italy) and then at the Politecnico di Milano, he is, since 1997, 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, with particular emphasis on polymer reactions and reaction-separation processes based on continuous chromatography. More recently, his interest in chromatographic separations is evolved in the area of biomolecules with specific focus on therapeutic proteins and monoclonal antibodies. The general aim of his research is the development of new concepts for the downstream processing of these materials. A major focus is currently the development of integrated continuous up and downstream processes for the purification of therapeutic proteins, their PEGylation reactions and other processes of interest in the pharmaceutical industry.
Massimo Morbidelli is co-author of more than 500 papers, 11 international patents and four books. He serves as an associate editor of the ACS journal of Industrial & Engineering Chemistry Research, and is a member of the scientific board of several international scientific journals. He is the recipient of the 2005 R.H. Wilhelm Award in Chemical Reaction Engineering of the American Institute of Chemical Engineers and of the Gerhard Damköhler-Medaille of DECHEMA.and VDI-GVC.
Massimo Morbidelli is a cofounder of ChromaCon Ltd., a spin-off company from his research group. Since 2007, ChromaCon Ltd. brings new chromatographic processes (MCSGP-technology) for the purification of proteins and peptides to the market.
Morten Munk, Senior Technology Partner,
Global Business Development, NNE Pharmaplan
Morten Munk has over 25 years of industry experience in biopharmaceutical development and manufacturing and is a globally recognized technical expert in the field. He has authored or co-authored a number of technical articles and guidelines. Moreover, his technology expertise coupled with thorough business understanding, means that he is frequently invited to give scientific and technical presentations at international conferences. In addition, Morten is active in the biopharmaceutical community for example as member of scientific committees for various international conferences and as volunteer in international industry organizations such as ISPE and PDA. Morten Munk joined NNE Pharmaplan as Senior Technology Partner in 2015.
In 2001 he co-founded CMC Biologics A/S, where he held a position as Vice
President for Business Development. Prior to founding CMC Biologics, Morten
held a position as principal scientist at Novo Nordisk A/S in which he was
responsible for the CMC part of several projects, which have bene
commercialized successfully. During his career, Morten has completed work
assignments in both the US and EU.
Sadettin Ozturk, Ph.D., Assoc Deputy Director, Process and Analytical Development, MassBiologics
Dr. Sadettin Ozturk is currently the head of Process and Analytical Development at Mass Biologics in Boston, USA. He has had a long career in cell culture process development, technology transfer, product licensing, and commercial manufacturing (Verax, Bayer, GlaxoSmithKline, and Johnson & Johnson). He led process development activities and played a key role in the licensing and commercialization of three monoclonal antibodies, Stelera®, Simponi®, and Sylant®. In addition, he transferred and supported the commercial manufacturing of Kogenate®, BeneFix®, and Remicade®.
Todd Przybycien, Ph.D., Professor, Chemical Engineering and Biomedical Engineering, Carnegie Mellon University
Todd M. Przybycien, Professor of Biomedical Engineering and Chemical Engineering at Carnegie Mellon University, received Bachelors degrees in chemical engineering and in chemistry from Washington University in St. Louis and Masters and PhD degrees in chemical engineering with a minor in biology from Caltech. Todd started his career with Monsanto Agricultural Company where he worked in bioprocess development for about two years. He then spent eight years at Rensselaer Polytechnic Institute followed by another seventeen at his current institution, Carnegie Mellon, where he was the Founding Head of the Biomedical Engineering Department. Todd’s primary research interests are in the areas of biopharmaceutical downstream processing and drug delivery. Current work includes developing next-generation affinity chromatography media with enhanced selectivity and robustness, developing precipitation-based separation processes, exploring how systematic and stochastic uncertainty propagates in downstream processes and single-use versus multi-use process equipment decision-making. Current drug delivery work includes surfactant-enhanced pulmonary drug delivery and PEGylated protein delivery from depot/microsphere delivery devices.
Ricardo Silva, Ph.D., Researcher, Animal Cell Technology Unit, IBET
Ricardo Silva received his Master degree in Chemical and Biochemical Engineering from Faculdade de Ciências e Tecnologia – Universidade Nova de Lisboa in 2008. His PhD studies focused on the development and optimization of countercurrent adsorption processes. At the moment, he is downstream processing researcher at Animal Cell Technology Unit in iBET, targeting continuous purification processes and identification of new purification strategies for viral vaccines and vectors.
Andrew Sinclair, FREng, MSc., President & Founder, Biopharm Services Ltd.
He has 30 years design and operational experience in the biopharmaceutical industry with direct responsibility for manufacturing, logistics, maintenance and capital programme management. He has developed Biopharm Services into a leading provider of bioprocess modelling and knowledge management tools supporting bioprocess innovation. Prior to Biopharm Services he was Director of Engineering and Logistics at Lonza Biologics. Andrew has an MSc in Biochemical Engineering from UCL. He was a finalist “The Manufacturing Processing Pillar Thoughts of the decade finalist” at the 2012 BioProcess International Awards.• Leader • Entrepreneur • Innovation and Vision • Principal Consultant.
Peter Tiainen, Ph.D., Prinicipal Scientist, Protein Purification Technology, Novo Nordisk A/S
Peter Tiainen holds a position as Principal Scientist at the department of Protein Purification Technology at Novo Nordisk, Måløv, Denmark. His work includes development of in-process analysis methods, early process development and supporting research projects with purified proteins with main focus on coagulation factors currently. Peter holds a PhD in biochemistry from Lund University in Sweden, his thesis focusing on novel chromatography resins. This, in combination with his understanding of peptides, gained while working at Polypeptide laboratories in Malmö, Sweden and the experience acquired through his work at Novo Nordisk where chromatography is the main every-day topic, makes Peter very knowledgeable within the field of chromatography. Peter is a driver when it comes to integrating down-stream and up-stream processes at Novo Nordisk, Global Research (GR) in Måløv. The high demand for research protein, sometimes somewhat fragile requiring fast processing, in combination with the time constraints caused by a generally high research pace triggered the interest in continuous and automated bioprocessing.
Andrew Zydney, Ph.D., Distinguished Professor, Chemical Engineering, The Pennsylvania State University
Dr. Andrew L. Zydney is currently Distinguished Professor of Chemical Engineering at The Pennsylvania State University, having served as Head of that Department from 2004-2014. Professor Zydney received his Ph.D. in Chemical Engineering from M.I.T. in 1985, and he was a faculty member in the Chemical Engineering Department at the University of Delaware from 1985 - 2001. Professor Zydney's research is focused on membrane science and technology, with a particular emphasis on bioseparations and the purification of high value biological products. He has published more than 170 articles on these topics, including invited contributions to the Encyclopedia of Bioprocess Technology and the Handbook of Biomedical Engineering. Professor Zydney is the Editor-in-Chief of the Journal of Membrane Science, and he serves on the Editorial Boards for Separation and Purification Reviews, Separation Science and Technology, Journal of Colloid and Interface Science, and Biotechnology and Bioengineering. He served as President of the North American Membrane Society in 2002 - 2003, and was a member of the Board of Directors for 9 years. He was elected a fellow of the American Institute of Medical and Biological Engineers in 1998 and of the American Institute of Chemical Engineers in 2001. Dr. Zydney received the Excellence in Teaching Award from the University of Delaware in 1994, and he is a past recipient of the Distinguished Teacher Award (1999) and the Outstanding Young Faculty Award (1990) from the American Society of Engineering Education. Since 2002 she has been an international consultant, trainer, speaker and writer for biotech and biosimilar products. She first worked independently as NMR Biotech Services (Germantown, MD), then in 2004 joined Biologics Consulting Group, Inc. (Alexandria, VA). In 2014, she decided to return to independent consulting, forming Global Biotech Experts, LLC. In 2003, she was one of six industry and two FDA founders of the CaSSS CMC Strategy Forum, which has led to the publication of major industry/regulatory white papers on CMC topics, and is now being held annually in North America, Europe, Asia and Latin America.
Advances in Purification Technologies
Julie Bomholt, Ph.D., Protein Specialist, Aquaporin A/S
Julie Bomholt recieved her PhD from University of Copenhagen. Her background is within biotechnology and nanoscience. She joined the Cleantech company Aquaporin A/S in 2010 where she is currently working as protein specialist. Her research activities have been focusing on production of membrane proteins as well as reconstitution and functionality.
Srinivas Chollangi, Ph.D., Scientist II, Biologics Process Development, Bristol-Myers Squibb
Dr. Srinivas Chollangi is a Downstream Process Development Scientist working at Bristol-Myers Squibb. His area of expertise is in Protein Purification, High-Throughput Automation and Biophysical Characterization of biologics. Prior to joining Bristol-Myers, Dr. Chollangi has worked as a Post-Doctoral Fellow at UT Southwestern Medical Center in Dallas. He has earned his PhD in Biomedical Engineering at The University of Oklahoma, Norman.
Theodore T. Diakov, MSc., Assoc Scientist, Downstream Process Development, Bristol-Myers Squibb
Theodore T Diakov holds a Master of Science Degree from SUNY Upstate Medical University where he researched the regulation of the V-ATPase protein complex. This work led to two first author and one second author science publications. He currently works as an Associate Scientist in the Biologics Downstream Process Development Department at Bristol-Myers-Squibb on optimizing and developing purification processes for biological molecules. His interests include improving the understanding of unexpected behaviors during chromatography purification.
Linda Gombos, Ph.D., Postdoc, Institute of Biotechnology (BOKU), Process Science Downstream Processing, BOKU-Boehringer Ingelheim RCV
Ph.D. in Structural Biochemistry at the Eötvös Lorand University (Budapest, Hungary)
Postdoc at the University of Heidelberg (Germany)
Currently at Boehringer Ingelheim RCV; focused on protein refolding
Alois Jungbauer, Ph.D., Professor, Department of Biotechnology, University of Natural Resource and Life Sciences, Austrian Centre of Industrial Biotechnology
Professor Alois Jungbauer received his PhD in Food Technology and Biotechnology from the University of Natural Resources and Life Sciences Vienna, Austria 1986. He serves since then as a professor at the Department of Biotechnology. He teaches Protein Technology and Downstream Processing and Bioprocess Engineering. He also acts as area head and Dep. Director of Research in the Austrian Centre of Industrial Biotechnology. He is currently working in the field of bioengineering of proteins, plasmids and viruses with special focus on expression, downstream processing and characterization of large biomolecules.
As a proliferate researcher he has more than 250 publications on recombinant protein production and bioseparation, 15 patents and 12 book contributions and recently a monograph entitled “Protein Chromatography , Process Development and Scale Up”. He is executive editor and co-founder of Biotechnology Journal, and member of editorial boards from numerous journals in the area of biochemical engineering.
Thomas Linke, Ph.D., Senior Scientist, Purification Process Science, MedImmune, Gaithersburg.
Dr. Linke is a process development scientist in the Purification Process Science department at MedImmune. Dr. Linke has extensive downstream process development experience and supports pre-clinical through late stage drug development projects. Prior to joining MedImmune in 2008, Dr. Linke worked as process development scientist for Lonza Biologics (formerly Cambrex BioSciences, Baltimore). Dr. Linke received his Ph.D. in Biochemistry from the University of Bonn, Germany.
Adam J. Meizinger, Ph.D., BS, Process Engineer II, Manufacturing Science and Technology Laboratory, Genzyme, A Sanofi Company
Adam received his BS degree in Biology from the University of Massachusetts – Dartmouth in 2004. While spending 4 years in Antibody-Drug Conjugate Manufacturing at ImmunoGen, Inc. he developed a passion for process-improvement and moved on to Purification Development at Genzyme, A Sanofi Company. After 3 years in Development, he transitioned to the newly-formed Manufacturing Sciences and Technology Lab where he currently works on continuous process improvement.
David O’Connell, Ph.D., Lecturer, Director MSc Programmes Biotechnology, School of Biomolecular & Biomedical Research, University College Dublin
David O'Connell has a PhD in molecular biology from UCD, postdoctoral research experience in antibody engineering in the Marks lab at UCSF, and is currently Director of taught masters programmes in biotechnology & biotherapeutics at UCD. Through patenting of the EF affinity technology he has funded a series of research grants that have developed a strong research team and a dynamic collaborative team to develop and commercialise the technology.
Andreas Schaubmar, Ph.D., Head of Downstream Processing, Large Molecule Research, Roche Pharmaceutical Research and Early Development, pRED, Roche Innovation Center Penzberg
Dr. Andreas Schaubmar was trained as a Biologist at the University of Regensburg in Germany. He got his Ph.D. in 1998 in Molecular Developmental Biology at the Ludwig-Maximilian University of Munich. After working for 2 years as a scientist at the Max-Planck Institute in Martinsried he joined Roche in 2001. For several years he has now been leading the Department for Downstream Processing in Large Molecule Research, belonging to Roche Pharmaceutical Research and Early Development, pRED. There he developed in his group several purification processes for therapeutic proteins and transferred them to GMP. He is currently located in the Roche Innovation Center Penzberg in the South of Munich, Germany.
Stefan R. Schmidt, Ph.D., MBA, Vice President, GMP Operations, Renstchler Biothechnologie
Dr. Stefan R. Schmidt MBA, 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 led the unit of Protein Sciences as Associate Director. In the last 10 years he worked intensively with fusion proteins, just recently publishing the first comprehensive book on that topic.
Medha J. Tomlinson, Ph.D., Senior Scientist, Global Biologics – Protein Sciences, Abbvie Bioresearch Center
I received my doctorate from the University of Cincinnati specializing in mass spectrometry and did post doctoral work with Prof. Charles Wilkins at UC-Riverside working on protein characterization. I joined BASF at the time working on small molecule projects and my role gradually expanded to supporting Biologics programs. I led a group supporting antigen purification and characterization using mass spectrometry for oncology and immunology programs and currently lead the Biologics Protein Purification group at Abbvie within the Global protein sciences group supporting antigen purification for all therapeutic areas within Abbvie.
Cornelia Walther, Ph.D., Post-Doc, Institute of Applied Microbiology/Biopharma Austria Process Science, University of Natural Resources and Life Sciences Vienna
Cornelia Walther studied Biotechnology at the Technical University of Berlin specializing on Industrial Biotechnology. She did her PhD at the University of Natural Resources and Life Sciences Vienna (BOKU) in the working group of Prof. Alois Jungbauer working on solubilization and refolding of protein from inclusion bodies. During her academic studies she spent more than one year at Bayer Healthcare LLC and Lawrence Berkeley National Laboratory in Berkeley, CA working on automation of analytical assays and chromatography screening and on the separation of proteins based on their number of thiol-groups using modified monolithic capillaries. She is currently working as a PostDoc at BOKU Vienna in a co operation project with Boehringer-Ingelheim RCV dealing with automation of process development in up- and downstream of bioprocesses
Wei Zhang (Ms), Ph.D., Research Scientist, Downstream Processing, Bioprocessing Technology Institute, Singapore
Dr. Zhang Wei is a research scientist in downstream processing group of Bioprocessing Technology Institute Singapore, which is led by Pete Gagnon. Her current research interest is in the development of novel methods for therapeutic antibody purification and the optimization of purification processes for industrial application.