Biopharmaceutical proteins differentiation

The three main sources of competitive advantage in the manufacture of high value protein products are first to market, high product quaUty, and low cost (3). The first company to market a new protein biopharmaceutical, and the first to gain patent protection, enjoys a substantial advantage. The second company to enter the market may find itself enjoying only one-tenth of the sales. In the absence of patent protection, product differentiation becomes very important. Differentiation reflects a product that is purer, more active, or has a greater lot-to-lot consistency. 

Another challenge is the delivery of a biopharmaceutical to its site of action, as the injection of molecules in solution leads to a partitioning of the molecules according to their physicochemical properties. One approach to deliver particles injected intravenously is based on the concept of differential protein adsorption. After injection the particles adsorb blood proteins according to physicochemical surface properties of the particles. The adsorbed proteins determine the cells to which the particles will be directed (Muller and Keck, 2004). 

Metabolites, vitamins, organic and amino acids, and specialty chemicals are commonly referred to as small molecules, particularly in the therapeutic world to differentiate these compounds from proteins or peptides, commonly named biopharmaceuticals or biologi-cals. Many of the same unit operations are applied for the recovery and purification of small molecules as described above. Purification of bulk products has cost constraints, whereas pharmaceuticals are subject to strict purity requirements. 

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