Sunday Training Workshops to Fast-track Your KnowledgeTraining to learn about various aspects of process chromatography will be presented on the Sunday preceding the meeting (free to student registrants if space is available, noting that paid participants receive priority consideration and the student must pre-register to participate). Certificates of completion recognizing attendance will be awarded. The PREP Symposium reserves the right, without notice, to modify the workshop material or schedules, as well as to amend the roster of workshop presenters. Workshops are open to meeting and non-meeting participants.
Workshop 1: 9:00am - 12:15pm Preparative Chromatography for BiopharmaceuticalsLecturers: Giorgio Carta, University of Virginia Alan K. Hunter, MedImmune Alois Jungbauer, BOKU, Vienna This workshop will focus on the theory and practice of biomolecule chromatography. Since mass transfer and the structure of the stationary phase influence deeply chromatographic performance, the main emphasis is on describing adsorption/desorption kinetics in single and multicomponent systems and determining the relationship between stationary phase properties and process performance. The latest advances in stationary phase developments will be reviewed along with methods for their experimental characterization. Design and optimization strategies for capture and high-resolution applications will be discussed. Topics: Adsorption equilibrium and transport in single and multicomponent systems; Stationary phases for small and large biomolecules; Design and optimization for capture and high-resolution steps Lecturers: Giorgio Carta received his Ph.D. in Chemical Engineering from the University of Delaware in 1984. Since then he has been a professor in the Department of Chemical Engineering at the University of Virginia, where his research focuses on transport phenomena and bioseparations. He regularly organizes professional courses on various aspects of bioseparations, including a course on protein chromatography development and scale-up together with Alois Jungbauer. Alan Hunter received his Ph.D. in Chemical Engineering from the University of Virginia in 2002 and is currently Principal Scientist in the Process Biochemistry Group at MedImmune. Prior to joining MedImmune he held positions of Process Engineer at Cambrex Bio Science Baltimore, and of Senior Principal Scientist at Pfizer Biologics. Dr. Hunter has broad biotechnology experience and expertise in areas including process development for large-scale cGMP manufacture of biologics, recombinant biopharmaceutical purification, and technology transfer and scale-up. Alois Jungbauer is the head of protein technology and downstream processing at the Department of Biotechnology of the University of Natural Resources and Applied Life Sciences in Vienna (Austria). For more than 20 years, Professor Jungbauer has worked in biochemical engineering, with a focus on bioseparation, where he has published widely and holds 15 patents. For over 10 years, he has organized a biennial professional course in protein chromatography focused on mass transfer, dispersion, and scale-up.
Workshop 2: 9:00am - 12:15pm Preparative Chromatography for Intermediates and APIsLecturers: Olivier Dapremont, Ampac Fine Chemicals Kathleen Mihlbachler, New Jersey Institute of Technology Larry Miller, Amgen This workshop will focus on development of method for the preparative purification of small molecules for the pharmaceutical industry. After an introduction of the theory, optimization and practice of prep HPLC, SMB and SFC for small molecule separations, the instructors will present practical approaches to the development of preparative separation through a series of examples. The attendees will learn valuable information and techniques to apply in the laboratory and at manufacturing scale to increase throughput and performance. Topics: Prep HPLC batch - Theory, optimization and practice; SMB - Principle and technology; SMB - Examples and applications; SFC - Theory, equipment and examples Lecturers: Dr. Dapremont has worked on the development of SMB technology since 1992. He is Director of Process Technologies at AMPAC Fine Chemicals where his role encompasses the development of SMB separations using multiple SMB units ranging from 4.6 mm to 1 m in diameter as well as developing continuous processes for the manufacturing of APIs. Dr. Mihlbachler has worked in the field of separation technology with an emphasis on chromatography for the last 15 years. In her current role as a Senior Research Investigator II in PRD at BMS (New Brunswick, NJ), she develops purification/separation processes for pharmaceutical intermediates and API, in particular for chiral compounds and peptides. Dr. Mihlbachler held positions at Pharmacia/Pfizer (kg-scale chiral separation) and Eli Lilly and Company where she also evaluated multi-column continuous chromatography for bio-molecule purification. Dr. Miller is a Principal Scientist in the Discovery Analytical Sciences group at Amgen in Cambridge, MA. He graduated with a B.S. degree from the University of Illinois in Urbana-Champaign in 1984 and a M.S. from Roosevelt University in 1990. In 1984 he joined Searle in suburban Chicago as an analytical chemist. He spent twenty years performing small molecule achiral and chiral purifications at the mg to multi-kg scale, utilizing preparative HPLC, steady state recycle (SSR) and simulated moving bed (SMB) chromatography. While at Searle/Pharmacia, Larry managed a group of ten scientists within a purification center of excellence providing purification support to three R&D sites. In 2004 Larry joined Amgen where he is responsible for discovery and early development purification support utilizing preparative SFC and HPLC.
Workshop 3: 1:30pm - 4:30pm Bringing Pharmaceuticals and Biomolecules to Market (and keeping them there)Lecturers: Lois Ann Beaver, LAB Enterprises Joan Newburger, Johnson & Johnson Consumer Products Worldwide This workshop will focus on Quality by Design, Quality Systems Management, Science-based Risk Management, Process Analytical Technology and Continuous Process Improvement as tools that can be incorporated into basic drug development processes. We will examine the relationship between good drug development science, quality and regulatory flexibility, with emphasis on application to the biopharmaceutical industry. Particular attention will be placed on the practice of Quality by Design. A practical study of how the integration of quality and risk management is used in an application to bring a mAb to market will be presented. In addition, we will address the challenges for technology and regulation created by the emerging biosimilars industry along with the current status of internationally developed guidance. Topics: Regulatory aspects, QbD, Process Analytical Technology, Quality System Management, Biosimilars, Marketing Lecturers: After a multi-decade career with the U.S. Food and Drug Administration, in 2009 Lois Ann Beaver founded a regulatory consulting group, LAB Enterprises. While working in FDA’s Office of the Commissioner, Lois served on the FDA Pharmaceutical Quality Council that conceived and developed quality by design; led activity for FDA’s joining the international Pharmaceutical Inspection Cooperation Scheme; worked as liaison with international organizations such as WHO, most recently focusing on biosimilars; managed the export program for international investigations of unapproved pharmaceuticals; was associate director for international harmonization working on international best practice and standardization activities such as the ICH; was US Coordinator for Veterinary ICH; and served as delegate to the APEC (Asia Pacific Economic Cooperation) Life Sciences Innovation Forum. Lois also led international projects on anti-counterfeiting of medical products and good manufacturing practices in pharmaceutical firms in emerging countries, and established a pharmaceutical information center in Cairo. Dr. Newburger has worked in pharmaceutical development for over 25 years at Wyeth Ayerst, Bristol-Myers Squibb and, currently, Johnson & Johnson. During the first half of her career, she led separations groups supporting medicinal, formulations and process chemists. For the past 7+ years, Dr. Newburger has led cross-functional teams, including clinical, CM&C, toxicology, regulatory and commercial members, having the responsibility of developing and implementing strategies for all Phases of prescription drug development and post-Approval support.
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