Target validation and assay development
RD&C provides support in biological target validation and mode-of-action analysis based on biological system technologies including design, planning, and coordinating experimental strategies. Novel biochemical and cell-based assays can, amongst others, be developed for antiviral testing, enzymes, ion channels, GPCRs, innate immune response, cell differentiation, etc. Additionally, RD&C offers development, qualification, validation, and establishment of high-content compound screening platforms as well as cellular assays, infection assays, biochemical assays, homogeneous assay formats, etc.
Lead discovery and optimization
RD&C offers strategic evaluation of medicinal chemistry technologies for lead identification, lead optimization, and pre-clinical candidate profiling including ligand and structure-based approaches and fragment-based discovery. A main focus lies on optimization the interface between computational chemistry (molecular modelling) and medicinal chemistry. Data analysis, statistical evaluation, and interpretation of screening data in context with in-house and public data bases will increase success rates.
Pre-clinic evaluation
RD&C offers in silico– and expert-based prediction of metabolic pathways and support for identification and isolation of potential first and second phase metabolites. Design, planning, execution, and control of in vitro and in vivo studies will be developed together with the client and the CRO. RD&C will manage and supervise the experiments with regular reporting and feedback to all partners.
For chemical process development RD&C offers support for synthetic route scouting and process scale up using a Quality-by-Design approach and assists with sourcing of starting materials, intermediates, and APIs. Additionally, analytical method will be selected, developed, and validated in respect to regulatory requirements for registration.
Moreover, RD&C assists in further essential parts of the pre-clinical development like stability study design, identification of degradation products, impurity evaluation and profiling, and physicochemical and solid phase/ polymorph characterization.
Finally, RD&C supports its clients in pre-formulation study design and formulation optimization as well as evaluation of re-formulations for drug-repositioning.
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