We apply immunology and cell-based assays and couple this with cell and tissue-based expression analysis for hypothesis testing and target validation. We are differentiated by the time and effort we invest in understanding your key questions, and contexualising this with the underlying biology. This enables us to apply the most appropriate complex model systems relevant to your target and the disease biology. Our cell biology experts will assemble and evaluate the published information on your novel target and collaborate with you to select the best in vitro models to achieve your objectives.
Starting from a position of deep understanding of the biology of your therapeutic target, we apply a multi-step screening process that links binding characterisation with functional assays of increasing physiological relevance, allowing triaging of drug candidates based on desired characteristics. The two key attributes for selection are the interaction with the target of interest and the ability to modify target biology. We can design and conduct a range of binding and functional assessments, starting with antigen binding analysis by SPR, ELISA or flow cytometry to cell-based reporter systems, ultimately leveraging complex primary cell assays for the most promising candidates. We work in collaboration with our partners, enriching discovery campaigns with reliable data, driving decision making with confidence.
We combine our immunology knowledge with our bioanalytical design expertise to support your lead optimisation and characterisation efforts to generate a comprehensive in vitro pharmacology data package that supports your regulatory submission. Working closely with your scientists, we provide you with the binding, efficacy and potency data essential to your internal decision-making processes. For antibody-based drugs, we provide full characterisation of binding, effector function, in vitro pharmacology, MoA characterisation and non-regulated in vitro toxicology studies.
Following lead selection, focus switches to the manufacturing process and the creation of a consistent, efficacious and safe product. Quality by design principles require the definition of a quality target product profile (QTPP) from which a range of critical quality attributes (CQAs) are identified to allow informed decision making throughout the manufacturing life cycle. Assays that measure biological activity and are required to define MoA, can be considered precursor methods to the formal potency assay through evolution to the potency method or by providing supporting data for its selection. Starting with early phase characterisation activities, we’re able to support you to identify and evaluate a variety of relevant potential potency assay methodologies. We create data sets that justify the long-term selection of the adopted format, whilst generating intrinsic knowledge of assay performance and product characteristics to enhance the analytical method development.
We can support you in the development of a cell-based potency assay.
The goal of any biosimilar development program is to create a biosimilar version of the reference product that can be demonstrated to have no clinically meaningful differences in terms of safety, purity and potency. Consequently, biosimilars are subject to a unique regulatory approval process requiring a more extensive analytical assessment phase in comparison to a conventional biologic. We have performed analytical similarity studies for more than 15 different reference antibody products and supported several successful biosimilar marketing authorisations. Our success is attributed to our experience in controlling assay performance while maintaining appropriate sensitivity. We consider the product attributes that may influence functional outcomes and ensure that the test methods used are conducted with biological relevance in mind. We provide a range of off-the-shelf solutions, platform approaches and custom development solutions.
We can comprehensively characterise the functional attributes of your biosimilar.