This webinar is an overview of the key elements of cell culture and fermentation, including culture medium, equipment requirements, and processing conditions and parameters.
Why Should You Attend:
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 basics needed to understand the fundamental, yet essential, components of cell culture and fermentation, i.e. upstream biologics processes, in a biopharmaceutical setting.
The course will begin with a description of cell lines commonly used in the industry and the nutrients required in the culture medium for the cells to grow. The equipment that is needed from the laboratory to the pilot and commercial scales, as well as a discussion of the basic aspects of reactor design, will also be covered. This will lead into a discussion of the importance of aseptic operation, including personnel technique and equipment operation. Next, basic mathematical models commonly used to describe cell growth and product formation will be presented with practical examples. Methods for analysis of cultures, including both in-process and off-line testing, will be discussed to provide an understanding of parameters needed for process development and for successful manufacture in a clinical and commercial setting. Lastly, highlights of regulatory guidelines applicable to upstream biologics processes will be covered.
Added by complianceonlinecom on January 4, 2013