The growing number of biologics advancing to market brings an increased demand for thorough characterization. To meet these needs, our scientists provide a complete suite of characterization capabilities. Unlike traditional small molecule drugs, biological products are inherently heterogeneous, so differences in molecular structure or the presence of impurities can dramatically change efficacy, immunogenicity or toxicity.
We also help you navigate critical regulatory guidances. The ICH defines guidelines regarding quality, specifications, stability, comparability and method validation in development activities concerning biological products. The guidance calls for inclusion of analytical methods for control of API as well as adventitious agents. It also specifies that the physicochemical and biological properties of biomolecules be defined, especially as they relate to manufacturing. Acceptance criteria are also recommended.
The guidance on specifications indicates that identity tests should be highly specific for the drug substance or drug product and should be based on unique aspects of its molecular structure and/or other specific properties. More than one test (physicochemical, biological and/or immunochemical) may be necessary to establish identity. Physicochemical characterization generally includes determination of the composition, physical properties and primary structure of the desired biological product. In some cases, information regarding a higher order structure may be obtained by appropriate physicochemical methodologies. The purity and impurities of biological products are usually estimated by a combination of methods (e.g., HPLC, UPLC and electrophoresis).
Stability tests are necessary, especially for protein and peptide drugs due to their structural complexity and instability. The most common chemical degradation mechanisms for peptides and proteins are deamidation and oxidation. The guidance on stability of peptides and proteins recommends tests of both chemical stability and biological activity.