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Balancing the demands of product quality, process productivity and scalability remain the key challenges for professionals involved in upstream process development. This course will address these core issues for both mammalian and microbial products.
Starting with cell-line development, the course will move on to focus on media selection, screening, initial upstream process development and quality concerns to help you in laying the foundations for a successful and productive process. On day two, you will explore upstream equipment in-depth and start to consider process characterisation, performance validation and scale up. You will also discuss the needs of the downstream process, how collaboration between USP and DSP teams can be facilitated and how process transfer can be addressed.
Taught by Margit Holzer, an experienced bioprocess development expert, this course will deliver a wealth of examples and discussion to help you in your learning.
What will you learn?
Understand the intricacies of cell line development including sequencing, cloning, productivity and cell banking
Consider selection of media for different production stages, testing and characterisation, viral and GMP concerns
Discuss upstream equipment, the types available and its applications
Integration with DSP
Integration with DSP
Note how USP can be successfully integrated with downstream processing, how scale up can be managed and process transfer facilitated
Understand requirements for control strategy and process performance validation
Who is this course for?
This course will be of interest to professionals involved in upstream process development, including:
- Process scientists
- Technicians and technologists
- Bioprocess engineers
- Cell line development specialists
- Cell culture specialists
- Product managers
- Process development managers
- Validation technicians
Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.