Introduction to Biopharmaceutical Manufacturing

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Introduction to Biopharmaceutical Manufacturing

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Event Information

Part of the Bioprocess Training Academy

Spring: May 03 - 04, 2010 · World Trade Center Boston · Boston, MA

Also available via IBC ONLINE

Document Title

Course Overview

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"This was a comprehensive course that gave an excellent overview of manufacturing processes. Instructor was extremely knowledgeable and experienced and skilled in engaging the class."
- S. Lee, Director, Biogen Idec

Course Information

Audio and/or video recordings are not permitted.
Certificate of Attendance: All participants who complete the course will receive a certificate of attendance at the conclusion of the class.

Description

This course introduces the fundamental processes and operations in the manufacture of biopharmaceuticals. Beginning with expression systems and moving through fermentation, cell culture, recovery, purification, formulation and filling, we will discuss the process steps involved in producing biological products. You will also be introduced to the basic concepts of process design and analytical methods for characterization of biological products. The course will conclude with a description of the role of quality and the regulatory environment under which biologicals are produced, including validation. Though the manufacture of biopharmaceuticals is complicated and difficult, this course will provide a perspective on the many operations that make up a manufacturing process and help you understand how they work together to produce safe and effective products.

Who Should Attend?

Production and operations personnel: managers, supervisors, associates
Quality assurance personnel: managers, specialists, technical writers
Regulatory affairs personnel: managers, CMC specialists
Engineering and facilities staff: managers, engineers
Supplier company marketing staff and sales representatives

Instructors

Scott M. Wheelwright, Ph.D., President and CEO, Strategic Manufacturing Worldwide, Inc.
Dr. Scott M. Wheelwright has over 25 years experience in biopharmaceutical manufacturing with firms such as Abbott Laboratories, Chiron and Scios. Dr. Wheelwright holds a Ph.D. degree in chemical engineering from the University of California at Berkeley and is the author of a book on protein purification. Dr. Wheelwright currently provides consulting assistance with outsourcing and manufacturing compliance, particularly in Asia.

Marilee Brooks, Industry Consultant
Marilee Brooks has over 15 years of operations experience including heading up the Manufacturing Science Group at Chiron. Her group executed several successful Technology Transfers and associated FDA filings from both in house and contract manufacturing clients. Currently she is working with UC Berkeley to launch a center focused on operational research collaborations between academia and industry. She holds a Masters in chemical engineering from UC Berkeley.