Key Topics Covered:
Who Should Attend?
This 2-day course gives a detailed introduction to the upstream operations in a biopharmaceutical production process used in the development of recombinant protein for human therapeutic use. This will include both hands-on practical and theory components.
During this course trainees will be introduced to cell culture technique using small scale shake flasks. Trainees will then gain hands on practical experience on 150L stainless steel bioreactors using detailed experimental procedures and SOPs to prepare and run a steam in place sterilisation on the 150L bioreactor. Trainees will then build on the knowledge and experience gained during the course theory and practical sessions and start a production batch on the 30L stainless steel bioreactor.
- Overview of the biopharmaceutical production process
- Mammalian cell culture aseptic technique
- Analysis of cell growth and nutrients in culture
- Cell culture scale up equipment including shake flasks and disposable bioreactors
- Preparation of a 150L stainless steel bioreactor for steam in place (SIP)
- Set up and operation of a 30L stainless steel seed bioreactor including inoculation and sampling.
This course is designed for operators, technical staff, engineers and managers wishing to increase their knowledge of the upstream operations in a modern bioprocessing plant.
Upon successful completion of this module the learner will be able to:
- Understand the theory and practice of culturing mammalian cells in an aseptic environment from small to large scale
- Understand the process of inoculating a stainless steel seed bioreactor.
- Use GDP to follow and complete SOPs, batch records and log books.
- Count cells using both an automated and manual method
- Interpret the nutrient and metabolite levels of cell culture medium
- Understand the mammalian cell culture scale up process and the equipment used.
- Prepare and run an SIP procedure on a 150L stainless steel bioreactor
A competency based assessment will be undertaken at the end of the course. This will certify proﬁciency in the theory and practical skills.