Amino Acid Analysis of Monoclonal Antibodies

The peptide and protein based pharmaceuticals are a rapidly expanding class of therapeutical agents that are used to treat a wide variety of health conditions, including cancer, metabolic and auto-immune diseases, HIV, and more. Biologic drugs, such as monoclonal antibodies, are derived from living organisms and are usually very expensive. As many biologics are coming off of patents, the market is ready for cost-saving biogenerics. But all proteins, including monoclonal antibodies, have complex structures that determine their function. Differences in structure would alter biological activity leading to changes in safety and efficacy of the drug.

Table I: HPLC program

ICH Q6B is a guidance document that provides a set of internationally accepted specifications for biotechnological and biological products to support new marketing applications. It establishes the set of criteria to which a drug substance, drug product, or material should conform to be considered acceptable for intended use.

Table II: Pinnacle PCX column oven program

Determining amino acid composition following hydrolysis is listed in ICH Q6B as a way to characterize the protein and to confirm its identity by comparing with amino acid composition deduced from the gene sequence of the desired product. Amino acids analysis data is also used to accurately determine the protein content.

Figure 1: Chromatogram of hydrolyzed sample of IL-17F monoclonal antibody.

The amino acids analysis with post-column derivatization is a very sensitive, reproducible, and rugged method and it has been a preferred approach for laboratories running biological samples, protein, peptides, and foods analysis. Pickering Laboratories Inc. offers many amino acids analysis products including post-column derivatization instruments, columns, eluants, reagents ,and standards. All products are designed to work together to deliver optimum results for any chosen sample.

Method

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