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ComplianceOnline, Online Event
2013-01-25
Course Description:
This webinar will define the key elements of cell culture and fermentation, including culture medium, equipment requirements, and processing conditions and parameters.
Course Objective:
Biologics-based products are a rapidly growing segment of the pharmaceutical industry and an understanding of how these molecules are developed and produced is important for those new to the field. This webinar will provide the basic understanding on the fundamental, yet essential, components of cell culture and fermentation, i.e. upstream biologics processes, in a biopharmaceutical setting. This session will describe the common cell lines used in the pharmaceutical industry and the required culture medium nutrients for the cells to grow. It will also discuss the importance of aseptic operation, including personnel technique and equipment operation. It will cover the culture analytical methods, both in-process and off-line testing. This session highlights the regulatory guidelines applicable to upstream biologics processes. Following topics will be discussed during the training:
- Commonly used cell types in biopharmaceuticals
- Culture medium
- Key equipment
- Basic models for growth and product formation
- Process parameters and analytical testing
- Aseptic technique
- Elements of reactor design
- Overview of regulations
Who will benefit:
This online training will provide valuable guidance to the following personnel:
- Junior-level scientists and engineers
- Process technicians
- Production supervisors and managers
- Quality assurance and quality control personnel
- Regulatory affairs
- Personnel in the microbiology lab
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Organized by:
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Complianceonline |
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Invited Speakers:
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Lori Herz, Ph.D. is currently a Professor of Practice of Chemical Engineering at Lehigh University. She is the Associate Director of the Bioengineering Program at Lehigh, where she teaches the Metabolic Engineering and Biotechnology Laboratory courses. Additionally, she is affiliated with the Integrated Product Development program, for which she advises student teams working on their capstone design projects. Prior to joining Lehigh, Dr. Herz worked at Bristol-Myers Squibb Company for nine years. She started in Technical Operations, supporting technology transfer and the manufacture of sterile liquid and lyophilized drug products. She later managed early-phase clinical operations and process scale-up of protein therapeutics.
In addition to her position at Lehigh, Dr. Herz is the owner of Herz Biotechnology Consulting, which she started in 2011. She received her B.S. in Chemical Engineering from Cornell University and her Ph.D. in Chemical and Biochemical Engineering from Rutgers, the State University of New Jersey. She is currently the faculty adviser for the Lehigh chapter of ISPE, as well as a member of AICHE and the Society for Biological Engineering.
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Deadline for Abstracts:
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2013-01-24
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Registration:
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For Reg: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702691?channel=Hummolgen
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E-mail:
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referral@complianceonline.com
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