Physico-chemical and Biochemical characterization
To ensure a safe and well controlled biological product, it is required that both activity and biochemical properties are well described. The API should be extensively characterized in terms of composition, the presence of heterogeneities, and higher order structure. To provide a safe biologic, one needs to demonstrate analysis of:
A dedicated team of experts equipped with state of the art instrumentation helps you to safeguard consistent quality throughout the product lifecycle. Validated cGMP ensures fulfillment of regulatory requirements, enabling you to advance development. Get in touch today to see how we can assist you.