Archived Content

Formulation & Downstream Processing

Speaker Bios
Overcoming Formulation Challenges for Biopharmaceutical Development
August 18-19, 2014

Paul DiGregorio, Ph.D., Director, Strategic Accounts, Freeslate, Inc.

Ernesto Freire, Ph.D., Professor, Biology and Biophysics, Johns Hopkins University

ERNESTO FREIRE is the Henry Walters Professor at the Johns Hopkins University. He has been a member of the Department of Biology and Biophysics since 1986. Dr. Freire obtained his doctorate in Biophysics from the University of Virginia.
Dr. Freire is a world recognized expert in biological thermodynamics. He performs research in the thermodynamics of protein stability, protein-protein interactions, and protein-ligand binding. Dr. Freire has pioneered the development of drug design and optimization strategies using thermodynamics and microcalorimetric techniques. Dr. Freire has been associated with several startups including Fulcrum Pharmaceuticals, Ception Therapeutics and currently AVIA Biosystems where he is Chief Scientific Officer. The author or co-author of over 240 publications and several patents, Dr. Freire is on the editorial board of Proteins: Structure, Function and Bioinformatics, Current Protein and Peptide Science and Chemical Biology and Drug Design. He has served on many scientific advisory committees for the National Institutes of Health and the National Science Foundation. Dr. Freire is an Honor Member of the Spanish Society of Biochemistry and Molecular Biology, and a member of the Academy of Sciences of Latin America.

Qingyan Hu, Ph.D., Scientist, Formulation Development, Regeneron Pharmaceuticals, Inc.

Dr. Qingyan Hu received her PhD in chemistry from the University of Toronto in 2005. After 2-year postdoc at National Research Council Canada, she joined Roche Global Formulation Research in 2007. At Roche, Qingyan has led formulation research projects on peptides, siRNA and small molecules. In 2013, Qingyan joined Formulation development group at Regeneron Pharmaceuticals. She is responsible for early stage and late stage formulation development for several mAb development projects.

Qingyan Hu, Ph.D., Scientist, Formulation Development, Regeneron Pharmaceuticals, Inc.

Dr. Qingyan Hu received her PhD in chemistry from the University of Toronto in 2005. After 2-year postdoc at National Research Council Canada, she joined Roche Global Formulation Research in 2007. At Roche, Qingyan has led formulation research projects on peptides, siRNA and small molecules. In 2013, Qingyan joined Formulation development group at Regeneron Pharmaceuticals. She is responsible for early stage and late stage formulation development for several mAb development projects.

Min Huang, Ph.D., Principal Scientist, Pharmaceutical R&D, Pfizer, Inc.

Jianmei Kochling, Ph.D., Director, Quality Science and Analytical Technology, Genzyme, a Sanofi Company

Jianmei Kochling is a director of Quality Science and Analytical Technology in Biologics division at Genzyme, a Sanofi company. She is responsible for implementing new and emerging technology to the next generation analytical methods during analytical life cycle management for Genzyme commercial products as well as protein characterization supporting Genzyme manufacturing and product related programs. In addition, her group is responsible for developing methods supporting both upstream equipment cleaning validation and downstream column life cycle studies, and other regulatory related commitments. Dr. Kochling was a scientific associate director at Genzyme leading a small molecule analytical development program until its NDA filing. Dr. Kochling is a steering committee member for both the AAPS dissolution and stability focus groups. She is also a USP expert committee for enzyme use in dissolution. Dr. Kochling worked at GSK, Waters Corporation, Praecis Pharmaceuticals, and Vertex Pharmaceuticals prior to joining Genzyme. Jianmei received her PhD from Northeastern University, MS from Virginia Commonwealth University, and BS from Fudan University

Christopher Roberts, Ph.D., Associate Professor, Department of Chemical Engineering, University of Delaware

Dr. Roberts is an Associate Professor in the Department of Chemical and Biomolecular Engineering at the University of Delaware. He received his BChE from UD, and his Ph.D. in Chemical Engineering from Princeton University. He joined the department in 2002 as an Assistant Professor after working in pharmaceutical R&D for Pfizer, Inc. as a formulation scientist. The Roberts laboratory focuses on fundamentals and applications of protein physical and chemical stability, (mis)folding, aggregation, kinetics, statistical mechanics, and phase behavior to address questions of biopharmaceutical product design and manufacturing. Selected honors include the AAPS New Investigator Award in Pharmaceutics and Pharmaceutical Technologies, the Ebert Prize from the Journal of Pharmaceutical Sciences, and the University of Delaware College of Engineering Excellence-in-Teaching award.

Curtiss P. Schneider, Ph.D., Senior Engineer I, Protein Pharmaceutical Development, Biogen Idec

Since joining Biogen Idec in 2012, Curt has been responsible for the process development, characterization, and validation activities for several late stage protein drug products. Prior to joining Biogen Idec, Curt was a postdoctoral research associate at the Massachusetts Institute of Technology, where he also received his Doctor of Philosophy degree in Chemical Engineering. Research interests for his doctoral thesis included developing novel excipients for the inhibition of protein aggregation and elucidating the mechanism of action of commonly used excipients. Later during his postdoctoral study, research interests shifted to protein engineering to specifically mutate out aggregation hot spots on the surface of mAbs, thus lowering their aggregation propensity.

Shuai "Sunny" Shi, Ph.D., Senior Scientist, Sterile Product Development, Merck

Dr. Shi received his PhD. degree in pharmaceutical sciences from the University of North Carolina at Chapel Hillin 2010. In a short period of three years, Dr. Shi has six publications in leading, peer-reviewed international reputed pharmaceutical journals. Several of these manuscripts are also firsts in their field. Two describe, for the first time, the delivery of mycafungin intended for treatment of fungal infections following lung transplants and support the clinical work of collaborators at Duke University. Additionally, two of these manuscripts illuminate a conundrum in pharmaceutical analysis that of cascade impactor profile comparisons to demonstrate particle size equivalence. Dr. Shi creatively developed an alternative method which has gained a wide interest from the pharmaceutical aerosol field. Dr. Shi was also a recipient of the MOPH graduate scholar award for his outstanding PhD research in developing respirable tuberculosis vaccines. In 2010-2011, Dr. Shi completed a post-doctoral fellowship with one of the most distinguished scientists in the field of biotechnology, Professor Russell Middaugh, at the University of Kansas, where he was the project leader for multiple industry sponsored projects on protein and vaccine formulation and characterization. Dr. Shi has also published several exceptional research articles during this period. In one publication, he successfully discovered the aggregation mechanism of a recombinant protein sEphB4-HSA, a therapeutic candidate for the treatment of vascular proliferative diseases and cancer such as Kaposi sarcoma (KS). This article was ranked one of the ten most downloaded papers published in 2012 and thus being featured on the journal’s website. In 2011, Dr. Shi took up a position as a Senior Scientist in the Sterile Product Development group at Merck. Since then he has made significant contributions to the biophysical characterization and formulation development of Merck biosimilar, biobetter and novel programs. This includes leading a high-performance team to develop new technologies for protein characterization; supervising junior-level scientists on their research activities and serving as functional representatives on multiple protein characterization and formulation projects. Dr. Shi’s excellent work in Merck has won him several times Merck Award of Excellence, one provisional formulation patent on a biosimilar, and several publications. Dr. Shi is a member of multiple scientific societies such as AAPS, ACS and Sigma Xi. He is also a peer reviewer for a number of international journals.

Indresh K. Srivastava, Ph.D., Vice President, Product Realization, Protein Sciences Corp.

Dr. Srivastava joined Protein Sciences in 2012 as Vice President, Product Realization. He has a strong background in vaccine development, particularly in immunogen design, purification, analytical and formulation development, and has published extensively in these areas. Dr. Srivastava served on the NIH special emphasis study section focused on vaccine development for ten years, and in 2011 he co-edited the book, "Development of Vaccines: From Discovery to Clinical Testing." Previously, Dr. Srivastava spent more than twelve years at Chiron Corporation/Novartis Vaccines and Diagnostics, Inc. in various capacities, including Head (AI), Protein Biochemistry; Head, Vaccine Manufacturing; and Head, Protein Expression and Analytics. He also spent about two years at the Vaccine Research Center, a division of the National Institute of Allergy and Infectious Diseases, where he led the purification, analytical and formulation development of vaccine candidates for clinical evaluation.

Yu Tang, Ph.D., Principle Scientist, Integrated Biologics Profiling, Novartis Institute of Biomedical Research

I am currently holding a Principle Scientist position in Integrated Biologics Profiling of Novartis since 2009. I obtained my Ph.D in 2008 in the field of Pharmaceutical Sciences. My research is focusing on protein pre-formulation profiling and preclinical/clinical formulation development, as well as advanced protein delivery systems exploration. My recent research interests are in resolving challenges in protein formulation, such as solubility, viscosity, and aggregation.

Mark Yang, Ph.D., Director, Fill Finish Development, Commercial Process Development, Genzyme, a Sanofi Company

Mark Yang is the Director for Fill Finish Development at Genzyme. After earned his PhD from the University of Georgiain 1997 and completed his postdoctoral research at NIH, Dr. Yang has since been working in protein drug delivery, protein formulation, and fill finish development in a number of companies, including Genzyme, Acceleron Pharma, and Baxter. Dr. Yang is the invited speaker for many national and international meetings. He has published over 20 research papers in peer-reviewed journals and is the (co)inventor of numerous patents.

Anthony L. Young, Ph.D., Principal Scientist, Pharmaceutical Research and Development, Pfizer, Inc.

Anthony Young is a principal scientist in the Pharmaceutical Research and Development group at the Pfizer St. Louis, Missouri Laboratories. He earned his B.S. in Chemistry from Southern Illinois University at Edwardsville in 1992 and his M.S. in Chemistry from the University of Missouri St. Louis in 1995. He has 20 years of experience in physical chemistry measurements, material science, pharmatherapeutic and biotherapeutics formulations. His current responsibilities include developing regulatory toxicology and first in human formulations for monoclonal antibody, drug conjugate and vaccine formulations.

Yuhong Zeng, Ph.D., Senior Scientist, Alcon Laboratories, Inc.

Zhiqing Zhu (Zach), Ph.D., Research Investigator, Drug Product Science and Technology, Bristol-Myers Squibb Co.

Zhiqing Zhu (Zach), Ph.D., is a research investigator at the Drug Product Science and Technology department at Bristol-Myers Squibb Company in New Brunswick, New Jersey. Since his joining at BMS in 2010, Zach has been working on the formulation development for a number of biologic molecules, including monoclonal antibodies, fusion proteins, PEGylated proteins, etc. He is also the drug product development team leader for a Phase I program, responsible for developing clinical and commercial formulation, supporting manufacturing and technology transferring, and providing support to clinical sites. Zach completed his Bachelors in Science and Masters from Nanjing University, China, his Ph.D. in Biochemistry from University of Notre Dame at South Bend, Indiana. He has authored 7 peer reviewed papers and 1 book chapter. He is also a regular reviewer for several journals, including the Journal of Pharmaceutical Science.

Speaker Bios
High-Concentration Protein Formulations
August 20-21, 2014

Robin Bogner, Ph.D., Associate Professor, Department of Pharmaceutical Sciences, School of Pharmacy, University of Connecticut

Dr. Bogner is Associate Professor of Pharmaceutics in the Department of Pharmaceutical Science at the University of Connecticut where she is also a member of the Institute of Materials Science and a UConn Teaching Fellow. She received her B.S. in Pharmacy from Rutgers University, M.S. from the University of Iowa, and Ph.D from Rutgers University after which she joined the faculty of the University of Connecticut. Dr. Bogner’s research interests are focused on solid dosage forms, both oral solids and parenteral lyophilized solids. Modeling the effect of variation on product quality and product performance is a recent area of interest. Dr. Bogner has served on a USP Expert Committee and various other leadership roles in AAPS and AACP. She is on the editorial boards of Pharmaceutical Research, Pharmaceutical Formulation and Quality, and Pharmaceutical Development and Technology where she is Editor for mini-reviews submitted to that journal.

Mark L. Brader, Ph.D., Principal Scientist, Protein Pharmaceutical Development, Biogen Idec

Ravi Chari, Ph.D., Senior Scientist, Pharmaceutics, AbbVie Bioresearch Center

Dr. Chari is a Senior Scientist in the Preformulation Group at AbbVie Bioresearch Center in Worcester, MA. His primary work involves early discovery screening of biologics candidates for acceptable solubility, viscosity, and degradation profiles. He also supports later formulation development of API and Drug Product. His research interests include computer modeling of proteins to predict physicochemical properties.

David Gold, Ph.D., Associate Director, Business Development, Halozyme Therapeutics

Kapil Gupta, Ph.D., Senior Fellow, Integrated Biologics Profiling, Novartis Institute of Biomedical Research

Jan Jezek, Ph.D., CSO, Development, Arecor Ltd.

Jan Jezek, the principal inventor of the core protein stabilisation technologies, is a biochemist with a strong background in physical chemistry. Currently responsible for R&D activities, platform development and technical IP support in the field of stabilisation of biologics. He played a crucial role in the development of stabilising technologies for commercially important proteins that allow preservation of protein structure and biological activity during sterilisation by gamma radiation and during long-term storage at ambient temperature. Lead successful grant funded projects with TSB funding. Previously, a Principal Scientist at Insense Limited, he was responsible for development of novel medical devices from concept to market. Dr. Jezek holds a joint Doctorate from the University of Bedfordshire and the University of Chemical technology, Prague. He is a member of the Scientific Advisory Board of the Centre of Excellence in Biopharmaceuticals (University of Manchester). He is also a committee member of the Formulation Science & Technology Group (FSTG) at the Royal Society of Chemistry.

Ramil F. Latypov, Ph.D., Principal Scientist, Process & Product Development, Amgen, Inc.

I received my Ph.D. in Biophysics from the Institute of Theoretical and Experimental Biophysics, Russian Academy of Sciences. Subsequently, I spent three years as a post-doc in the group of Heinrich Roder at the Fox Chase Cancer Center in Philadelphia (USA). There I studied structural, thermodynamic and kinetic aspects of protein folding and denaturation. After completing post-doctoral training, I joined Amgen in 2003 as a protein formulation scientist. I am an expert in biophysical analysis of biomolecules and in the formulation of protein therapeutics. I made contributions to the understanding of aggregation and liquid-liquid phase separation of immunoglobulins and developed assays to measure aggregation propensity of multiple different Ab samples subjected to the same stress. I have worked on a variety of drug development projects including single domain proteins, peptibodies, Fc-fusion proteins, as well as monoclonal antibodies. Currently, I am contributing to the development of engineering and formulation technologies for poorly behaving therapeutic candidates.

Thomas Laue, Ph.D., Professor, Biochemistry and Molecular Biology; Director, Biomolecular Interaction Technologies Center (BITC), University of New Hampshire

Tom Laue is the Carpenter Professor of Molecular, Cellular and Biomedical Sciences, and professor of Material Sciences at the University of New Hampshire. He is the Director of both the Center to Advance Molecular Interaction Science and the Biomolecular Interaction Technologies Center. He received his bachelor’s degree in Natural Sciences from the Johns Hopkins University in 1971 and his Ph.D. in Biophysics and Biochemistry from the University of Connecticut in 1981. His post-doctoral studies were conducted at the University of Oklahoma. Between 1969 and 1975, he worked as a technician in the deep space program of NASA. He joined the University of New Hampshire in 1984 as an Assistant Professor, and teaches both undergraduate and graduate courses in biochemistry and biophysics. His research focuses on the development of instrumentation and methods that use the fundamental properties of mass and charge for examining macromolecular interactions. These instruments provide unique insights into these interactions, and have resulted in extensive collaborations with both academic and industrial labs. Tom has over 120 publications, serves on several editorial boards, and gives over one hundred lectures, seminars and workshops a year.

Yunsong “Frank” Li, Ph.D., Associate Principal Scientist, Bioprocess Development, Merck Research Laboratories

Dr. Yunsong Li is currently Associate Principal Scientist in bioprocess development of Merck Research Laboratories based in Kenilworth, New Jersey. He is responsible for the development of formulation and fill finish process for the manufacturing of Merck biopharmaceuticals. Dr. Li started his career in industry in 2006 with Amgen Inc. In 2007, he joined Merck Research Laboratories and held various responsibilities including analytical development, in-depth characterization and formulation development of therapeutical protein and vaccines. Dr. Li received his Ph.D. in Pharmaceutical Chemistry from the University of Kansas in 2007 and M.Sc. in Chemistry from the University of British Columbia in 2002. Prior to coming to North America, Dr. Li attended Peking University (Beijing, China) and received his B.Sc. in Chemistry in 1998.

Yuh-Fun Maa, Ph.D., Principal Engineer, Pharmaceutical Processing & Technology Development, Genentech, Inc.

Yuh-Fun rejoined Genentech in February 2010 and has over 20-year industrial experience in pharmaceutical/biopharmaceutical development and drug delivery. Prior to Genentech, he joined ALZA, a Johnson & Johnson Company, in 2002 to work on Macroflux Transdermal Technology, which was spun out to become Zosano Pharma in 2006, with responsibilities in developing stable solid-state formulations tip-coated on microprojections of the transdermal patch. Before ALZA, Dr. Maa accumulated extensive experience in developing protein/vaccine powder formulations for various drug delivery technologies during his employment with Genentech (1992-1998) and PowderJect Technologies/Vaccines (1998-2001). He holds a Ph.D. in Chemical Engineering from the University of Rochester in Rochester, NY (1989) and has also completed postdoctoral training at SRI International (1990). Dr. Maa has authored >50 peer-reviewed scientific articles and patents/patent applications.

Guangliang Greg Pan, Ph.D., Principal Research Scientist, Biopharmaceutical Research and Development, Eli Lilly and Company

Guangliang Greg Pan, Ph.D., received a doctorate in pharmaceutics from the University of Georgia in 2003. He completed his postdoctoral research in peptide transdermal delivery at Johnson and Johnson in 2004 and joined ImClone as a scientist and later promoted to senior manager in biologics formulation development. He was a senior research scientist at Novartis before he joined Eli Lilly and Company in 2007.  He is currently a principal research scientist in biopharmaceutical research and development at Lilly.

Dean Ripple, Ph.D., Leader, Bioprocess Measurements Group, National Institute of Standards and Technology

Dean Ripple joined the National Institute of Standards and Technology as a post-doctorate in 1991. Since 2010 he has led the Bioprocess Measurements Group, which develops standards and sensing technologies in support of biotherapeutic manufacturing and health care. His research focuses on standards for the counting and characterization of particles in therapeutic proteins. He has a Ph.D. in physics from Cornell University and an M.S. in biotechnology from Johns Hopkins University.

Pooja Sane, Doctoral Candidate, Department of Pharmaceutical Sciences, School of Pharmacy, University of Connecticut

Pooja Sane is a Doctoral Candidate in the Pharmaceutical Sciences program at the University of Connecticut. She received her M.S. from Northeastern University (2009) and B.Pharm from Mumbai University (2007). She is currently involved in several projects focusing on the variation in the heat transfer, product resistance and chamber pressure during lyophilization, under the guidance of Dr. Robin Bogner and Dr. Michael Pikal. During an internship at Pfizer she worked on several methods to resolve the long reconstitution times of high concentration proteins.

Indresh K. Srivastava, Ph.D., Vice President, Product Realization, Protein Sciences Corp.

Dr. Srivastava joined Protein Sciences in 2012 as Vice President, Product Realization. He has a strong background in vaccine development, particularly in immunogen design, purification, analytical and formulation development, and has published extensively in these areas. Dr. Srivastava served on the NIH special emphasis study section focused on vaccine development for ten years, and in 2011 he co-edited the book, "Development of Vaccines: From Discovery to Clinical Testing." Previously, Dr. Srivastava spent more than twelve years at Chiron Corporation/Novartis Vaccines and Diagnostics, Inc. in various capacities, including Head (AI), Protein Biochemistry; Head, Vaccine Manufacturing; and Head, Protein Expression and Analytics. He also spent about two years at the Vaccine Research Center, a division of the National Institute of Allergy and Infectious Diseases, where he led the purification, analytical and formulation development of vaccine candidates for clinical evaluation.

John Tsavalas, Ph.D., Assistant Professor of Materials Science, University of New Hampshire

Dr. John Tsavalas is an Assistant Professor of Materials Science at the University of New Hampshire and the co-Director of the Nanostructured Polymers Research Center. He holds degrees in Chemical Engineering from the University of Virginia (BSChE) and The Georgia Institute of Technology (MS and PhD). He joined the University of New Hampshire after working as a Senior Research Scientist in The Dow Chemical Company in Midland, Michigan USA. In industry he worked on a wide variety of polymer colloid related R&D with particular emphasis on nanostructured latex particles. Dr. Tsavalas was the co-organizer of the 2011 International Polymer Colloids Group Conference and will be the Co-Chair (2015) and subsequently Chair (2018) of the next two Polymer Reaction Engineering conferences. Dr. Tsavalas’ current active areas of research at UNH are colloidal nanostructure morphology development, sustainably derived polymer colloids, the interaction and distribution of water in polymer colloids, dynamic modeling of latex film formation, and dynamic modeling of protein stability and rheology at high concentration.

Jamie Tsung, Ph.D., Principle Scientist, Momenta Pharmaceuticals, Inc. 

Dr. Jamie Tsung received her Ph.D. in pharmaceutical sciences from the University of Connecticut.  Currently, she is a Principal Scientist at Momenta Pharmaceuticals.  Prior to Momenta, she worked for Shire, Baxter, and UCB. Her biopharmaceutical experience spans preclinical to marketed products, integrating formulation, characterization, processing technology, regulatory, and quality control providing a valuable perspective and creative approach to product development. 

Robert H. Walters, Senior Scientist, Biotherapeutics Pharmaceutical R&D, Pfizer

Dr. Robert Walters is a senior scientist at Pfizer in Biotherapeutics Pharmaceutical R&D. He earned a bachelor’s degree in chemical engineering from The Ohio State University in 2006 and a doctorate in chemical engineering from the University of Wisconsin-Madison in 2011. He has authored numerous scientific publications on the aggregation of polyglutamine containing peptides and proteins as a part of his thesis work. He joined Pfizer in 2012, where he has contributed extensively to the development of high concentration antibody formulations.

Wenhua Wang, Ph.D., Postdoctoral Fellow, Late Stage Pharmaceutical Development, Genentech, Inc.

I received my Ph.D. in Biophysics from University of Rochester in 2013. I am now working as a Postdoctoral Fellow in Late Stage Pharmaceutical Development Department of Genentech, Inc

Speaker Bios
Advances in Purification Technologies
August 21-22, 2014

Scott Banta, Ph.D., Associate Professor, Chemical Engineering, Columbia University

Dr. Banta is Associate Professor of Chemical Engineering and director of the Protein and Metabolic Engineering Laboratory at Columbia University. His research thrusts are aimed at the engineering of novel proteins and peptides for a variety of important applications, including drug delivery, energy production, biosensing, bionanotechnology, and bioseparations.

Shuang Chen, Ph.D., Senior Scientist, Purification Process Development, Pfizer, Inc.

Shuang Chen is a principal scientist at Purification Process Development group, Pfizer Inc. Shuang Chen received B.Eng. in biochemical engineering from Zhejiang University (China) in 2005 and Ph.D. in chemical engineering from Purdue University (West Lafayette, IN) in 2010.

Matteo Costioli, Ph.D., DSP Process Development Manager, BioProcess Science, Merck Serono

Graduated in chemistry at the University of Lausanne, Switzerland PhD thesis at the centre of biotechnology at the EPFL, (école polytechnique de Lausanne), working on new bio-separation techniques based on affinity precipitation. In 2004 Head of downstream at Apoxis (now part of Topotarget) a startup company. I developed purification processes for Mabs and fusion proteins (MegaLigand technology). From 2007 to 2010 Bioprocess and Innovation DSP specialist at Merck Serono. Responsible for the identification of best practices enabling DSP processes improvement and global process standardization. Also responsible for the evaluation and implementation of new technologies related to protein purification. Since 2010 Head of DSP. Leading the late stage process development group, responsible for the optimization and QbD validation of DSP processes from phase II to market

Yamuna Dasarathy, Ph.D., MBA, Director, Marketing, Pall Life Sciences

Dr. Yamuna Dasarathy has over 20 years of experience in the Biopharmaceutical Industry. Her expertise spans productive clinical research, downstream purification process development, product/services marketing and business development. Yamuna's current role focuses on marketing and growing Pall Life Sciences’ chromatography business in the Americas. Before joining Pall, Yamuna was in the CMO Industry, developing the business through effective marketing of cGMP manufacturing services. Prior to that, she was with Amersham/GE Healthcare Life Sciences managing and marketing the GE lab chromatography separations product portfolio. Yamuna has a PhD in Biochemistry and acquired an MBA from Rutgers, The State University of NJ.

Kathryn Golden, MEng., Scientist II/ Development Project Manager, Manufacturing and Process Sciences, Eleven Biotherapeutics

Ms. Golden is a process development scientist and development project manager in the Manufacturing and Process Sciences group at Eleven Biotherapeutics. She earned her Chemical Engineering BS and Bioengineering MS at MIT and previously worked with high density perfusion processes at Percivia LLC.

Anthony Grabski, Ph.D., Director, R&D, Semba Biosciences, Inc.

Dr. Anthony Grabski - Director of Research and Development for Semba Biosciences, Inc. Prior to joining Semba in October of 2006, Dr. Grabski’s appointments included Research and Development Group Leader for Purification and Protein Biochemistry at EMD Biosciences-Novagen, Madison, WI; Senior Research Scientist at CHIMERx, Madison, WI; Research Specialist at the University of WI-Madison Biotechnology Center; and Protein Fractionation Consultant for Sensortec, Ltd. Hamilton, NZ. He has over 25 years of experience in protein purification, chromatography, fermentation, and bioprocessing. Dr. Grabski’s current research efforts for Semba focus on the development of instrumentation, processes, and products to optimize purification of biologicals and chemicals through simulated moving bed chromatography (SMBC) and multi-column continuous chromatography (MCC). He received his Ph.D. (1995) and MS (1987) in Bacteriology from the University of Wisconsin-Madison.

Alois Jungbauer, Ph.D., Professor, Department of Biotechnology, University of Natural Resources and Applied Life Sciences Vienna, and 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.

Fletcher Malcom, MBA, Associate Director, Product Management, Repligen

Fletcher Malcom is a creative MBA graduate and biopharmaceutical industry professional, who spent his early career with Waters Corporation as a technical chromatography representative working with large pharmaceutical and biotechnology clients in the Eastern United States. Since leaving Waters, Fletcher has graduated with honors from Babson’s MBA program, and joined Repligen as a Product and Marketing Manager. In 2011 & 2012 Fletcher led all efforts to complete the development and commercialization of Repligen’s new platform of OPUS® pre-packed disposable columns.

Lam Markely, Ph.D., Scientist II, Cell Culture Development - High-Throughput Analytical Group, Biogen Idec

Raga Markely received his BS in Chemical Engineering from University of Wisconsin-Madison in 2006, and PhD also in Chemical Engineering from Massachusetts Institute of Technology in 2011. At UW-Madison, he did several undergraduate research projects on mathematical modeling of biological systems, fluid dynamics, and reaction kinetics in Chemical Engineering and Mathematics Department. At MIT, he worked with Prof. Daniel I.C. Wang in developing a new high-throughput sialic acid assay, optimization of cell culture conditions to improve sialylation, and high-throughput analysis of intraclonal variability in glycoprotein sialylation. After finishing his PhD thesis, he joined a High-Throughput Analytical Group at Biogen Idec in 2011. Since then, he has been developing new assays for high-throughput small-scale protein purification and product quality analysis, as well as performing routine support for these assays and other product quality analyses

Sophia T. Mundle, Ph.D., Senior Manager, Protein Chemistry, Sanofi Pasteur

Sophia T. Mundle, Ph.D. is a Senior Manager/Scientist in the Protein Chemistry group at Sanofi Pasteur, the vaccines division of Sanofi. Sanofi Pasteur is a global company which provides over one billion doses of vaccine each year protecting against 20 infectious diseases. Sophia completed her graduate degree at Northeastern University in Boston, MA after which she joined the Discovery Research team at Acambis, Inc. which was later acquired by Sanofi Pasteur. Dr. Mundle is responsible for the design and implementation of purification processes for virus and recombinant protein based vaccine candidates and reagent proteins.

Richard Nian, Ph.D., Research Scientist, Downstream Processing Group, Bioprocessing Technology Institute, A*STAR, Singapore

Dr. Richard Nian is the research scientist of Downstream Processing group of Bioprocessing Technology Institute (BTI, A*STAR, Singapore). He is currently focusing on the development of next generation bioseparation technology. Prior to joining BTI in 2012, Dr. Nian was the lead scientist at A-Bio Pharma (Singapore). In this role, he mainly took in charge of the downstream process development of various biosimilars in lab-scale and also led the pilot-scale downstream processing. Dr. Nian earned a PhD degree in Chemical and Biomolecular Engineering from National University of Singapore in 2008.

Alan Shupe, Ph.D., Scientist I, Biologics Manufacturing and Process Development, Bristol-Myers Squibb

Alan Shupe is a Scientist in the downstream process development group at Bristol-Myers Squibb. His experiences include both upstream cell culture and downstream chromatography process development in CHO cell platform. Alan holds a B.S. in Chemical engineering from Clarkson University and a Ph.D. in Bioprocess Engineering from the State University of New York College of Environmental Science and Forestry (SUNY-ESF). He also completed Six sigma training.

Lily Tsang, M.S.E., Associate Scientist II, Biologics Process Development Downstream, Bristol Myers Squibb

Lily graduated with a BSE and MSE in Chemical Engineering from the University of Michigan in 2011. Since then she has been a process development scientist at Bristol Myers and Squibb in the biologics purification group focusing on early and late phase development. Lily is actively developing purification platforms that leverage both statistical experimental designs and high throughput workflows to enable speed to market. She supports efforts in chromatography modeling and simulation. Additionally, she led the 6S transformation of multiple process development sites. Lily has earned her Lean Sigma Green Belt and continues to currently work on her Black Belt Certificate.

Danielle van Wijk, Ph.D., Project Leader, Downstream Processing, Synthon Biopharmaceuticals

Daniëlle studied Bioprocess technology at the Wageningen University in The Netherlands. During her PhD she studied enzyme expression in Aspergilli. After her PhD she worked at several small biotech companies and 8 years ago she joined Synthon Biopharmaceuticals were she is working in the Down Stream Processing department. Synthon Biopharmaceuticals has since then, developed itself from a company producing biosimilars to a specialty company. Currently, Synthon Biopharmaceuticals main focus is on the production of Antibody Drug conjugates.

Gregory Zarbis-Papastoitsis, Vice President, Process Development and Manufacturing Sciences, Eleven Biotherapeutics

Dr. Gregory Zarbis-Papastoitsis is the Vice President of Process Development and Manufacturing Sciences at Eleven Biotherapeutics. His group develops and transfers clinical and commercial enabling processes to CMO facilities, manages all activities regarding the development and manufacturing of Bulk Drug Substance and Drug Product. Prior to Eleven he was the Senior Director of the Downstream Development and Analytical groups at PERCIVIA, LLC, where they developed platform technologies for recombinant molecules produced in the PER.C6® human cell line. Previously he was Associate Director of Process Development and Analytical Sciences at Syntonix Pharmaceuticals in Waltham, MA. While at Syntonix, he was responsible for the development of a long lasting Factor IX, which recently completed registration clinical trials. Prior to Syntonix Dr. Zarbis-Papastoitsis spent several years with organizations such as Repligen, Seragen (worked on the purification development of IL2-Diptheria Toxin (ONTAK®)), Millennium Pharmaceuticals, and Abbott Biologics. At Abbott he was one of the key scientists that designed the second-generation commercial process for HUMIRA®. Dr. Zarbis-Papastoitsis received his B.S. in Biochemistry at the State University of New York at Binghamton where he continued his studies and received a PhD degree. After receiving his PhD degree he did 3 years of post-doctoral studies at Boston University School of Medicine.

Dr. Joe X Zhou, CEO of Genor BioPharma Co. Ltd., Walvax Group.

Joe is leading this company for mAb biosimilar and novel molecules from research, bioprocessing to market place with a rich pipeline, and two commercial facilities are under construction in China. Before joining Genor BioPharma, Dr. Zhou was a Scientific Director at Amgen, Thousand Oaks, USA. He demonstrated bio-industrial leadership in scientific innovation and technology evaluation, and is well known for implementation of membrane chromatography in mAb large-scale processing. He has proven records for design space for process robustness and viral clearance. Dr. Zhou has excellent reputation and an extended external network in Bioprocess Development community. Dr. Zhou was awarded as 2007 Amgen’s “Excellence n Science and Engineering” due to his major achievement and leadership on photo-oxidation on monoclonal antibody yellowing, and selected by Amgen as a visiting professor teaching the GMP Master’s Degree Program at PKU, People’s Republic of CHINA since 2007.

Andrew Zydney, Ph.D., Professor and Department Head, Department of Chemistry Engineering, The Pennsylvania State University

Dr. Andrew L. Zydney is currently Head of the Department of Chemical Engineering at The Pennsylvania State University and on the Board of Directors of ChromaTan, Inc. 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, he was elected a fellow of the American Institute of Medical and Biological Engineers in 1998, he 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.


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