Protein drug production and formulation

Over the past 40 years, the biopharmaceutical industry has evolved from the first FDA-approved insulin made in Escherichia coli cells to over 300 protein-based biopharmaceuticals. These drugs are highly complex, target specific, and require living cells to produce them. They include monoclonal antibodies, fusion proteins, interferons, interleukins, hormones, enzymes, and other classes of proteins. Although production processes vary widely in their details, they all share several key characteristics. Among these are fermentation or cell culture to produce the target protein using living cells (upstream processing), purification of the target using a variety of chromatographic methods (downstream processing), formulation of the drug product for parenteral delivery to patients, and final fill and finish steps before sending to market. Although these basic steps are universal, specific methods are still changing and improving to address the needs of new therapeutic modalities and the rise of biosimilar drugs.