Cell Culture in Biopharmaceutical Manufacturing

• Describe the advantages of using mammalian cells in the manufacture of protein-based therapeutic products
• Describe the typical composition of growth media used to culture mammalian cells
• Explain the concept of a cell bank, and how a typical inoculation procedure is performed
• Distinguish between suspended and adherent cell culture
• List the process parameters that are typically monitored and controlled in a cell culture process
• Distinguish between batch and continuous cell culture
• Explain how microbial contamination can adversely affect a cell culture process
• Explain the purpose of cell counting, and how it can be performed

Learner Benefits:

• Gain insights into why mammalian cells are favored in producing complex therapeutic proteins, including the necessity for post-translational modifications that only mammalian cells can perform.

• Learn about the complex nutritional needs of mammalian cells, including amino acids, vitamins, and growth factors, and how these are met in a controlled environment.

• Distinguish between suspended and adherent cell cultures, as well as batch and continuous culture systems.

• Enhance your technical skills by learning to monitor and control essential parameters like temperature, pH, and dissolved oxygen to ensure optimal cell growth and product quality.

• Understand the importance of sterility in cell culture, including sterilization techniques and the potential impacts of contamination on biopharmaceutical production.

• Equip yourself with knowledge about the critical roles of cell banks in maintaining cell line consistency and quality, as well as the procedures for inoculating and scaling up cultures.

• Learn how to perform cell counting using a hemocytometer, including techniques to distinguish live cells from dead ones, ensuring accurate quantification for successful cell culture operations.

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