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.
We support product characterization, analytical development, and analytical validation across modalities:
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.
AAV therapies are complex and present unique challenges to monitor quality and performance. These activities require careful planning and management of orthogonal techniques (e.g., analytical, structural and molecular). Breadth of capabilities and coordination are key to success.
Characterization – modality agnostic capabilities, modality specific solutions
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:
- Liquid chromatography (RPLC, HIC, SEC, IEX, UPLC) and electrophoretic methods (CE, CE-SDS, cIEF) using multiple detection modes
- Mass spectrometry approaches
- Binding e.g., ELISA, surface plasmon resonance (SPR), flow cytometry, cell-based assays, and molecular approaches
Analytical Development – modality agnostic capabilities, modality specific solutions
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.
Choosing the right partner for your biologics analytical development
Partner with us for:
- Early phase development to avoid costly pitfalls that require additional time, resources, and funding
- Reliable data to help expedite product quality decisions at vital stages of development
- Scientific experts and regulatory guidance to move your therapy from concept to clinic with confidence
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