Advanced Cell Culture & Fermentation – Process Development & Manufacture
Why Should You Attend:
Over the past two decades, many pharmaceutical and biotechnology companies have developed and launched biologics-based products, which have become significant assets in the pipeline and portfolio of these companies and, more importantly, help treat patients in need of these products. As such, an in-depth knowledge of approaches to producing these drugs competitively and efficiently, with a solid understanding of the technical aspects of these processes and the associated equipment, has become more important than ever.
The presentation will start by covering the bioreactor design, and will include the major categories of bioreactor models, applications for each design, as well as common types of agitators and impellers. This will lead into a discussion of the engineering involved in the development and scale-up of upstream processes, including selection of operating parameters and in-process specifications, and a description of models used for power input, as well as heat and oxygen transfer. Approaches to experimental design and quality by design (QBD) will also be included. Next, strategies for increasing titer, or product formation, at both the genetic and process levels, will be presented. The final topics of this workshop include recommendations for successful technology transfer from R&D to manufacturing, as well as a discussion of the applicable health agency guidelines.
Learning objectives:
- Learn different approaches for increasing titers
- Identify appropriate bioreactor and fermentor configuration types
- Understand agitator and impeller design requirements
- Define critical and non-critical process parameters
- Apply basic scale-up models pertaining to power input and oxygen transfer
- Understand principles of quality by design (QBD)
- Follow health agency requirements
