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-, Courtyard San Diego - Kearny Mesa, San Diego, CA
October 15-17, 2003
From product source to final bulk product, this three-day course introduces the critical issues of biopharmaceutical product development and manufacturing. The emphasis of the course will be on the manufacture of recombinant proteins and monoclonal antibodies for therapeutic use although development, manufacturing, and regulatory issues pertaining to other biologic products will also be covered. The critical aspects of cell line selection and characterization; process development, optimization, scale-up, and validation of biotechnology/biological processes will be covered through the use of lectures and group discussions. Throughout the course, emphasis is placed on providing participants with practical knowledge of what to do and when to do it from early process development through full-scale manufacturing. Group work will include the analysis of real manufacturing processes, designing responses to actual FDA 483 observations and regulatory questions related to processing of biological products, developing validation plans for biological processes, and exploring the economics of different production strategies.
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Organized by:
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IBC Life Sciences |
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Invited Speakers:
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Course Instructors:
Howard L. Levine, BioProcess Technology Consultants, Inc.
Gail Sofer, M.S., Director, Regulatory Services, BioReliance
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Deadline for Abstracts:
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-
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Registration:
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Phone (508) 616-5550 x1004
Fax (508) 616-5522
Email reg@ibcusa.com
Online www.LifeSciencesInfo.com/2949
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E-mail:
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reg@ibcusa.com
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