Surface plasmon resonance (SPR) assays are used across the life cycle of a biopharmaceutical, from target identification, through CQA determination, development, and on-going quality control. This article focuses on concentration assays associated with late-stage development and biotherapeutic drug chemical manufacturing and control.
The life cycle of a biotherapeutic product typically spans over thirty years. Early development can exceed five years, followed by late-stage development and clinical trials. Once approved for an initial indication, a successful product can remain in manufacturing and quality control for over twenty years, with additional indications added over time.
The growing trend of biosimilars, more complex antibody therapeutics and biologics puts increasingly higher demands on the assays and technologies used for screening, characterization, comparability and release testing. Attrition of therapeutic candidates during clinical development is the major factor in high development costs. Developability assessment teams are charged with evaluating potential drug candidates to allow pharmacologically effective new biological entities with favorable toxicity, immunogenicity and efficacy profiles to proceed through development, and decrease the risks of late-stage attrition. As the lead candidate enters late-stage development, it is important to define early on a detailed quality profile that is based on desired biological outcome and function, i.e. mode of action.
This comprehensive characterization of the candidate molecule is then used to set the appropriate range of critical quality attributes (CQA). These characteristics should be evaluated using the most sensitive approaches to identify drug product differences and evaluating the biological functions which are central to the mechanism of action. Surface plasmon resonance (SPR) using Biacore systems is widely used across the biopharma industry for both characterization and quality control.