Mammalian cells are used in the manufacture of a wide range of therapeutic proteins, including monoclonal antibodies, growth factors, hormones, and enzymes. These proteins are produced using bioreactors, which are large-scale culture systems that provide the necessary conditions for mammalian cells to grow and produce the desired protein.
The process of manufacturing therapeutic proteins using mammalian cells typically involves several steps, including:
- Cell line development: A suitable mammalian cell line is selected and genetically engineered to produce the desired protein.
- Seed train expansion: The cells are grown in a series of flasks or bioreactors to increase the cell density and volume.
- Production: The cells are transferred to large-scale bioreactors where they are cultured in a controlled environment, usually in a nutrient-rich media, to produce the therapeutic protein.
- Harvesting: The cells are harvested and the protein is purified using a variety of techniques, such as chromatography and filtration.
- Formulation: The purified protein is formulated into a final drug product, which may involve the addition of stabilizers, excipients, or other ingredients.
Manufacturing therapeutic proteins using mammalian cells is a complex and highly regulated process that requires strict quality control measures to ensure the safety and efficacy of the final product. Despite the challenges, the use of mammalian cells in protein production has revolutionized the field of biopharmaceuticals, and has led to the development of many life-saving therapies.