SC 1 Optimizing Media – Achieving Super Soup
To grow mammalian cells, researchers need to provide an optimal in vitro environment. The key feature of successful cell growth is the culture medium. ‘Achieving Super Soup’ requires finesse and know-how in order to combine the right ingredients at the right times under the right conditions to achieve high titers. This workshop explores strategies for enhancing the ‘soup’ needed to grow cells, from feed formulation and process development to analytical technologies and scaled-down HTP platforms, with an emphasis on providing helpful information that will benefit participants.
Martin Jordan, Ph.D., Associate Manager, Biotech Process Sciences - Medium Development, Merck Serono - BiographyScott D. Storms, Ph.D., Cell Culture Consulting, LLC - BiographyFrederic Girard, Ph.D., Managing Director, Spinnovation Analytical BV - Biography
Steven Chamow, Ph.D., Head, Technical Services, Avid Bioservices, Inc.- Biography
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SC 3 Ensuring Operational Excellence in Bioprocessing: PAT, QbD, DoE and Continuous Improvement - An Introductory Overview
Ensuring quality in bioprocesses that comply with regulatory requirements and mitigate risk often results in very high bottom-line costs. Adopting best practices early in the development process and customizing these approaches to operational excellence from other highly competitive industries are currently taking place in biopharmaceutical production. This course will provide both an overview of these approaches and how they work, as well as case studies of how these innovations have been applied in bioprocessing and elsewhere. Appropriate regulatory guidance will also be discussed.
Joyce Chiu, M.B.A., CPIP, Senior Project Manager, Honeywell Safety ProductsSusan Dana Jones, Ph.D., Vice President & Senior Consultant, BioProcess Technology Consultants, Inc.Sheila G. Magil, Ph.D., Senior Consultant, BioProcess Technology Consultants, Inc.
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SC 4 E.coli Innovations
Escherichia coli has proven its worth as a protein expression platform. Currently, E.coli is not viewed so much as an ‘alternative’ platform, but as a viable choice for achieving high-level expression of human genes and protein at a reasonable cost. This Dinner Short Course will explore strategies for successful E.coli protein expression, including:
Cynthia L. Kinsland, Ph.D., Research Associate, Biotechnology Center, and Head, Protein Production Facility, Cornell University
Francis Rajamohan, Ph.D., Senior Principal Scientist, Molecular and Structural Biology, Pfizer Global Research & DevelopmentGuido Seidel, Ph.D., Head of Process Development, Deputy Managing Director, Wacker Biotech GmbH
6:00 Overview—Protein Expression with Escherichia coli
Most proteins are not present in high enough levels to be economically purified in useful quantities from their natural hosts; therefore, recombinant expression systems are frequently employed. E. coli has several advantages over other systems: genetic manipulations are straightforward, the cultures are facile to grow, media is inexpensive and many recombinant proteins express to high levels in soluble and active form. Despite its limitations, E. coli has proven to be capable of producing a wide range of classes of proteins. Possible causes of failure to express well in E. coli include toxicity of the target protein, codon bias problems, poor protein folding, proteolysis of the expressed protein and mRNA problems (instability and hairpin formation). Despite the predicted high failure rate, the low cost and convenience of E. coli make it a rational starting point for attempting to obtain a recombinant protein. This talk will provide an overview of the methods available, and will outline a reasonable starting strategy as well as options and rescue strategies for the more troublesome projects.
6:45 Dinner Break
7:15 Advances in Recombinant Protein Expression and Purification
Francis Rajamohan, Ph.D., Senior Principal Scientist, Exploratory Medicinal Sciences, Pfizer Inc.
The increasing demand for milligram quantities of highly quality recombinant proteins for drug discovery and protein therapeutics warrants the needs for improved and efficient expression and purification technologies. Recombinant proteins are often produced in expression systems such as E. coli, insect cells, yeast, mammalian cells, and cell-free systems. Among these methods, the E. coli expression system is still considered the workhorse because of the ease, speed and cost. In addition, E. coli generated reagents are more homogeneous in terms of lack of post translational modifications which could promote the crystallizability of proteins. In this presentation, some of the advances in the growing field of protein expression and purification of recombinant proteins will be discussed.
8:00 Teaching E. coli New Tricks: ESETEC - A Family of Secretory E. Coli Strains Validated for cGMP Manufacturing of Recombinant Proteins
Guido Seidel, Ph.D., Head, Process Development, Deputy Managing Director, Wacker Biotech GmbH
The talk will focus and describe the use of Wacker’s E. coli-based secretion technology (Brand name: ESETEC®) for the expression of novel classes of therapeutic proteins, the so called next generation biopharmaceuticals (e.g. Fabs). Selected case studies will be presented. Wacker’s secretory system enables• expression of correctly folded proteins directly to the culture medium• high fermentation titers• easy recovery of these proteins from the culture medium• increased process efficiency and overall yield• reduced cost of goods by lowering the amount of DSP steps
8:45 Extended Q&A Discussion
9:00 End of “E. coli Innovations” Dinner Short Course
*Separate registration required.
Cynthia L. Kinsland, Ph.D., Research Associate, Biotechnology Center, and Head, Protein Production Facility, Cornell UniversityDr. Kinsland obtained a B.S. in chemistry and a B. A. in French literature from the University of Southwestern Louisiana and an M. S. and Ph. D. in bio-organic chemistry from Cornell University. Since 2001 she has directed the Protein Production and Characterization core facility at Cornell University. She focuses on the production of proteins for crystallography.
Francis Rajamohan, Ph.D., Senior Principal Scientist, Exploratory Medicinal Sciences, Pfizer Inc.Senior Principal Scientist (2001 to Present), Exploratory Medicinal Sciences, Central Research Division, Pfizer Inc. CT: Responsibilities include: (1) construct design/refinement, cloning and expression in E. coli, insect cells and mammalian cells; (2) Scale-up production using wave-bag bioreactors; (3) affinity purification, and biochemical characterization of proteins to support exploratory drug discovery, high throughput screening, structure-based drug design, and biomarker development; (4) generation of stable and transient mammalian cell lines; (5) technology and assay development (BacMam technology/ BIIC (Baculo Infected Insect Cells) technology); (6) collaborate with other technology areas (X-ray/NMR/biophysics/safety) and therapeutic areas (7) drive projects from idea to drug design.
Director (1997 to 2001), Department of Protein Engineering, Parker Hughes Cancer Center, MN: Headed the protein engineering group with 12 associates whose responsibility extended from expression construct design, protein expression, purification, characterization, and assay development through production of protein crystals. Developed and applied cutting edge technologies (Gene shuffling, alanine scanning mutagenesis, rRNA extraction, in vitro transcription/translation) necessary to elucidate the mechanism of antiviral activity of ribosome inactivating proteins (RIP’s). Performed functional characterization of proteins using biophysical tool such as surface plasmon resonance (BIA-CORE). Isolated inclusion bodies, solubilized and refolded into biologically active form. Also, generated several single-chain antibodies using phage display system.
Post Doctoral Research Associate (1992-1997) Department of Biochemistry, The Ohio State University, OH: Extensively used site-directed mutagenesis techniques to study the mechanism of action of Bacillus thuringiensis (BT) larvicidal toxins to pave the way for the construction of more potent and broader range second-generation toxins.
Guido Seidel, Ph.D., Head, Process Development, Deputy Managing Director, Wacker Biotech GmbH Guido Seidel, Ph.D., born in 1969 and originally trained as chemist. Specialized during PhD studies in large scale upstream technologies and biochemistry by working on 60.000L scale fermentation optimization.Joined sanofi aventis Germany in 1998, formerly Hoechst AG, as fermentation specialist and was promoted to several Head-of-positions in biopharmaceutical process development and production dealing with recombinant proteins from microbial and mammalian expression systems. Moved to Wacker mid of 2007 to be responsible as deputy managing director for the operational departments at Wacker Biotech. Has a strong focus on overall and integrated bioprocess development and production from small too large scale.
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