The Role Of Early Characterization Studies In The Assessment Of Advanced Therapeutic Potency

By Rubina Pal and Eva Morschl, Comprehensive Cell Solutions

Measuring the potency of an advanced therapeutic is rife with complexity. These drugs, often comprised of intricate cellular matrices, require a myriad of decisions for the companies pioneering them, particularly in the early phases of development. Even when the pathway is known, the mechanisms of action of these products are frequently not well understood; as a consequence, many organizations may run into unforeseen challenges when transitioning an asset from in vitro to in vivo testing.

Early product characterization can serve to uncover crucial information about a therapeutic candidate, affording new insight into its critical quality attributes (CQAs) and helping to shape better analytical assays. This applies to more than potency – deep characterization studies can ultimately provide crucial understanding to inform safety, purity, identity, and other core attributes.

Despite the technical advantages afforded by characterization studies, many organizations may be reluctant to spend the time and capital to conduct more detailed evaluation than is deemed necessary in early development. While the imperative to accelerate early development and manage spend is an important driver for industry, deep characterization studies and faster timelines are not mutually exclusive: in the end, the right characterization studies, undertaken early, can help developers establish analytical strategies that better support uninterrupted scaling.