Pharmaceutical Analysis Services

Characterisation of a biopharmaceutical product, determination of physico-chemical properties, biological activity, immunochemical properties, purity and impurities by appropriate techniques is essential for identifying the key characteristics of the product that should be considered when setting specifications for the product. These should be defined prior to conducting early clinical studies since they are essential for demonstrating product and process consistency and quality as well as demonstrating comparability, i.e. that a product used in early studies is the same as that intended for marketing.