By Daniel Galbraith, Ph.D.
In the past, product characterization was simple and standardized. Developers of small molecule pharmaceuticals performed a battery of tests around Phase II or III clinical trials, fulfilled the regulatory requirements of the pharmacopoeia and were done. In today’s complex world of biologics, success demands a more thoughtful approach and drug developers are investing in advanced analytics much earlier in the development process.
Product characterization is the essential foundation for successful biological drug development. In-depth knowledge of a product’s chemistry, structure, and biological activities facilitates easier process design to ensure the drug attains critical product safety, purity, and potency, as per ICH Q6B. Interrogation of product attributes using high resolution tools and techniques provides answers to crucial questions early on, such as: What are the structural attributes of the drug? And, how does this drug function biologically? Key is understanding the relationship between the basic physicochemical profile and biological activity and how this relationship affects clinical performance thus enabling a developer to make informed decisions that accelerate development and reduce risk throughout the product’s life cycle.