Introduction to Upstream Processing includes both hands-on practical and theory components covering cell vial thaw, aseptic techniques, cell counting, metabolic analysis, scale up, and bioreactor operation. Equipment such as wave bag reactors, stirred-tank reactors, as well as single-use bioreactors will all be utilized to reflect the current state of biopharmaceutical manufacturing technology.

Who should take this course?
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.

Topics

• Overview of the biopharmaceutical production process
• Mammalian cell culture aseptic techniques
• Analysis of cell growth and nutrients in culture
• Cell culture scale up equipment including shake flasks and disposable bioreactors
• Aseptically set-up and operate a 200L bioreactor
• Strategies for media preparation in single-use bioreactors

Learning Objectives

• Upon completion of this module, trainees will be able to:
• Describe the practice of culturing mammalian cells in an aseptic environment from small to large scale
• List the equipment required for scale up mammalian cultures
• Describe the cell expansion and inoculation methods in single-use systems
• Use GDocP to follow and complete SOPs, bath records and log books
• Count cells using both an automated and manual method
• Interpret the nutrient and metabolite levels of cell culture medium
• Aseptically prepare and run a 200L single-use bioreactor

Delivery

• In French
• 2 mornings of theoretical instructor-led virtual classroom
• 2 days practical at the CASTL Biomanufacturing Training Facility in Montreal

Assessment
A competency-based assessment will be undertaken at the end of the course. This will certify proficiency in the theory and practical skills.