How we work
Starting at the lead candidate selection stage, we help stakeholders to review the full scope of variables that should be considered for an effective product development strategy. We use a systematic, question-based approach that interrogates different intrinsic and extrinsic factors that could influence innate and adaptive immune responses in a particular target patient population. Systems biology and mode-of-action are also taken into account to estimate how the various factors might interact to influence incidence and severity of clinically impactful immunogenicity. Knowledge of different expression systems for recombinant proteins is applied to assess incremental risk associated with product-related and process-derived impurities.
We draw on our experience of analytical and bioanalytical techniques for monitoring risk factors to advise on choice of methodology and cost-effective resource allocation. If needed, we can support bioanalytical method development and validation activities, allied to providing advice on appropriate ways to interpret and present results.
Clinical impact is viewed from both efficacy and safety perspectives, moderated by weight of evidence relative to uncertainty. Then, we apply our collective experience of the regulatory environment to build a complete narrative for submission to Health Authorities.