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¼îÆ®ÄÚ½ºSUNDAY, January 8 Dinner Short Courses - 5:00 - 8:00 pm SC1: Characterization and Analysis of Sub-Visible Particulates Sub-visible particles present in these biopharmaceutical products are a product quality attribute and a potential patient safety concerns yet to be fully explored. Early and consistent particle detection, quantitation and control throughout the product life cycle of these drugs from development to commercial lot release is critical in mitigating any concerns. This requires appropriate analytical methods which can be applied to biopharmaceuticals across a large variety of protein concentrations and modes of administration. This workshop and interactive discussion will cover strategies to utilize complementary methods and techniques at different phases of product development. Instructors to be Announced. SC2: Protein Purification Kits and Packages What is available to simplify downstream processing? This course will examine what are the best protein purification aids on the market, how they work, and how much they cost. The course will also include buffers and reagents in order to provide the most comprehensive look at purification kits and technologies.
Instructors to be Announced. SC3: Biosimilars As more biologics come off patent, the world of biosimilars (ie. follow-on biologics) is emerging to exploit exposed opportunities. This course will provide insights into key considerations surrounding the development and approval of biosimilars.
Instructors to be Announced. SC4: Transient Protein Production in Mammalian Cells: A Short Story This short course will introduce the fundamental concepts needed to establish transient protein production in mammalian cells. This will allow for the rapid generation of milligram to gram quantities of recombinant proteins for therapeutic, functional, and structural studies. The course will combine instruction and case studies in an interactive environment.
Instructors: Richard Altman, Ph.D., Research Scientist, Alexion Pharmaceuticals Dominic Esposito, Director, Protein Expression Laboratory, SAIC-Frederick, Inc.
TUESDAY, January 10 Dinner Short Courses - 4:30 - 7:30 pm
SC5: How to Obtain Reliable Information from DLS and Multi-Detector SEC Systems for Biophysical Characterization Since its market introduction circa 30 years back, dynamic light scattering (DLS) has occupied a position of increasing popularity within the area of protein aggregate detection and characterization, due in large part to the non-invasiveness of the technique, the minimal sample volume & concentration requirements, and the quickness of data collection. While modern instrument design and software have removed much of the mystique traditionally associated with the technique, data interpretation is still an area of frustration for many DLS users. This workshop covers the basic theory behind DLS instrumentation, with a focus on the do¡¯s & don¡¯ts when it comes to data interpretation. Instructors: Kevin Mattison, Ph.D., Principal Scientist, Bioanalytics, Malvern Instruments Ulf Nobbmann, Ph.D., Senior Applications Specialist, Nanometrics, Malvern Instruments Jason Sanchez, Ph.D., Separations Product Specialist, Malvern Instruments SC6: A Practical Guide to the Use of Affinity Tags for Protein Purification Affinity tags are a great tool for purifying protein. This course will provide an overview of affinity tags, how they function, and which ones fit which protein best. If you want to learn about affinity tags, this course is perfect for you.
Instructors to be Announced. SC7: Optimized Strategies for Therapeutic Antibodies Discovery and Engineering This course will introduce a general work flow of an antibody project from preparation for its launch to having the drug candidates with an emphasis on selecting the proper discovery and engineering tools to achieve the intended goal. Topics to be discussed include: •Antibody generation project from an antibody engineer¡¯s point of view Who Should Attend? SC8: Harnessing CHO Cells: The Work Horses of Bioproduction Chinese hamster ovary (CHO) cells are the predominant cell factory for the production of biotherapeutics. Nevertheless, even with the recently released CHO cell DNA sequence, more research is required to harness their production potential. This interactive short course is designed to provide practical solutions for CHO cell lines including:
Instructors: Kelvin H. Lee, Ph.D., Professor, Chemical Engineering, Director, DE Biotechnology Institute, University of Delaware Hisahiro Tabuchi, Pharmaceutical Research, Chugai Pharmaceutical Co Ltd. Esther M. Yoo, Ph.D., Postdoctoral Fellow, University of California, Department of Microbiology, Immunology and Molecular Genetics Haruki Hasegawa, Ph.D., Cell Biologist, Protein Science, Amgen, Inc.
SC9: Introduction to the Baculovirus Expression System – History and Recent Advances What You Will Learn: This course is primarily intended for novice users and those unfamiliar with the system.
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