Biologics are determined experimentally for each cell type, and the complexity of the cell culture medium composition is to optimize a single culture medium. Different cell types have highly specific growth requirements. Protein quality. (Povidone) Mammalian cells effectively meet these standards through their post-translational modification system, which also enables them to become the dominant expression system for production in the biopharmaceutical industry. The main mammalian expression systems used to produce biotherapeutics include NS0 cells, CHO cells, etc. It is well known that the cell culture process and culture medium have an important impact on the expression and stability of therapeutic protein products and their critical quality attributes (CQA) (including glycosylation, sialylation, charge variation and aggregation, etc.). Optimal cell growth requires monitoring and control of process variables such as pH, dissolved oxygen, dissolved carbon dioxide and temperature. It can be said that the most important and crucial step in cell culture is to select a suitable in vitro growth medium. (Povidone) Cell culture medium provides an artificial environment that is conducive to the survival and proliferation of cultured cells and maintains the required pH and molecular osmotic pressure concentration. It is usually composed of a complex mixture of amino acids, vitamins, inorganic salts, glucose and serum, and is a source of growth factors for cell growth and protein expression.
The choice of cell culture medium is known to significantly affect the physicochemical properties of mAbs. The choice of medium depends on the type of cells to be cultured, as well as the purpose of the culture and the protein being expressed. (Povidone) Therefore, the composition brings many challenges. Over the years, the formulation of optimal culture media for the propagation of mammalian cells has attracted extensive attention due to the critical impact of culture media on bioprocess development in animal cell technology.
The factors that play a role in culture medium design come from three main sources, namely the properties of the product under consideration, the cell line used for protein production, and the manufacturing process (i.e., fed-batch, perfusion, or continuous). (Povidone) Due to differences in metabolism, different cell lines have different nutritional requirements, which needs to be properly considered during the culture medium optimization process. Although natural culture media are composed only of naturally occurring biological fluids and have proven to be useful and convenient for a variety of animal cell cultures, a key disadvantage is the possibility of poor reproducibility due to the lack of exact knowledge of the composition. Synthetic or chemical culture media can be prepared by adding nutrients (such as vitamins, salts, trace elements, carbohydrates, and cofactors) at defined concentrations.
