ABSTRACT
A key challenge in biotechnology is the production of proteins by large-scale cell culture in a cost-effective manner. The development of efficient and reproducible separation processes for proteins and peptides relies, in large part, on the availability of suitable analytical methods. Impurities unrelated to the product include components added to the culture medium or those used as raw materials in the purification process. The purity requirements for protein or peptide products will vary dependent upon the intended use of the material. Proteins intended as bulk commercial grade reagents, for example detergent enzymes, will have much lower purity requirements than pharmaceuticals, for which the purity requirements are rigorous and highly regulated. In general, impurities can be grouped as either related to the target protein, typically product variants, or as impurities unrelated to the product. The high degree of site dependent microheterogeneity known in many glycoproteins and the lack of methods are barriers to routine carbohydrate analysis.
