Basic Cell Culture & Fermentation - Process Development & Manufacture
Friday, January 25, 2013 from 10:00 AM to 11:15 AM (PST)
Palo Alto, CA
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.
Areas covered in this Seminar:
- 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.
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.