Orthogonal approaches to product characterization support better understanding of your asset's performance, safety, and the manufacturing processes for Drug Substance (DS) and Drug Product (DP). Identity, purity (including process- and product- related impurities), strength, and potency should be considered collectively to inform the best decisions about: Where and how to act, setting specifications, and understanding performance. A subset of approaches should move into Analytical Development to formalize assays to support testing under GMP required for Critical Quality Attributes (CQAs) defined by ICH Q6B.
It is important to recognize that all modalities and processes are different, but the attributes defining quality are consistent and must be understood and monitored.
It is imperative to understand product and process consistency and mitigate risk as related to safety and efficacy. This is defined by structure/function relationships and the primary attributes: Identity, purity, and potency. We employ both classic and progressive techniques to evaluate these ICH Q6B driven CQAs. This includes, but is not limited to:
To support testing for clinical use, assays must be performed under GMP conditions, requiring phase appropriate, fit for purpose validation. A subset of the approaches used for characterization are amenable to this transition and should confirm specifications regarding CQAs as defined by ICH Q6B.
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With ADCs it is important to look beyond drug-to-antibody ratio (DAR). Understanding how post translational modifications and conjugation may affect binding and potency is an important consideration that affects internalization and ultimately, potency.
How well do you understand the structure- function relationship with your molecule? With mAbs, it is important to understand binding performance, covalent modifications (post translational modifications and/or unintentional modifications) and how those factors affect performance.