Cell culture medium is critical to cell growth, metabolism, and protein expression. It provides for optimum pH, osmolality, and nutrients in an environment that is essential for cell survival, growth, and expression of proteins and/or metabolites and drug-substance modalities of interest (1). A complete medium typically contains basic nutrients such as carbohydrates, amino acids, lipids, salts, vitamins, trace metals, growth factors/hormones (e.g., insulin), antishear factors, and other chemicals that facilitate cell growth and protein expression and may stabilize recombinant protein…
Author Archives: Volker Moehrle
Process Improvements Increase Production Capacity of a Legacy Product
Implementation of postlicensure process improvements in the biopharmaceutical industry can benefit patients and drug manufacturers alike. Here we demonstrate through a case study how a change to the cell culture medium and process can be taken from proof of concept through scale-up to demonstration of feasibility. We further illustrate the scope and complexity of implementing a change in commercial manufacturing to realize significant benefits such as increased production capacity over an existing legacy process. The Importance of Postapproval Improvements Drug…