Design and synthetic routes for antibody conjugates, focusing on the linker and method of payload attachment. Stability of the linker while maintaining rapid release of the payload under the desired conditions were important factors. Critique of existing designs and designs overcoming problems identified were provided. Suppliers for key linker components and CROs and a supplier able to provide a novel linker architecture were also identified.
Key characteristics of the recognition element for application in the biosensing device were identified, namely binding kinetics and thermodynamics and their relationship with affinity, dynamic range and response time, specificity, stability, and specifications regarding quality. Different classes of recognition element were reviewed. Literature data on the most closely related systems was located and analysed. Tools were built, initially in Excel and subsequently Python to allow kinetic parameters of the recognition element to be matched to desired sensor characteristics.
Methods for impurity reference standards for drug products were developed using starting materials available in house in bulk. The approach of this project largely followed QbD principles with particular emphasis on safety, ease of operation, robustness and simple QC. The project culminated with successful tech transfer of methods to the client.