Analytical techniques play a major role in the development of biotherapeutics. Commonly, label-free technology solutions, such as SPR are used in later stages of biotherapeutic development to support the refinement of cell culture and downstream processes that preserve critical quality attributes of the therapeutic protein as well as ensuring a high yield.
Critically, SPR can be implemented at early stages in screening and testing strategies in order to provide better, faster and stronger analysis of drug candidates. They not only provide information about antigen kinetics and affinity but can also guide selection based on drug candidates effector function. To minimize risk and to get “true” affinity in binding analysis we have adopted the latest innovation in surface plasmon resonance, SPR, technology, Biacore™ 8K, to develop and qualify assays for monoclonal antibodies and other therapeutic proteins to ensure all critical quality attributes are set and controlled with accuracy and precision. Case-studies will be presented to illustrate how SPR is applied orthogonally in the workflow and successfully used to support the efforts to develop safe and efficient products in an economic fashion.