Contract Laboratory is pleased to announce that Agenda 1 Analytical Services has registered with ContractLaboratory.com - The Laboratory Outsourcing Network
The Analytical Group at Agenda1 has on site one of the widest ranges of specialist analytical equipment in Europe - covering both chromatographic and solid state techniques. Of more importance is our analytical development and validation skills, critical to providing the data needed to support a successful dossier. Our analytical work often follows on from our screening support in API form-optimization; both physical and chemical moiety optimization using salt, polymorph and solubilising screens. We have also supported numerous multi-formulation assessment programs, selecting and developing discriminatory analytical techniques to appropriately justify and document formulation development decisions.
As the full CMC process begins we move from "fit for purpose" methods to provide fully validated cGMP methods, for raw materials, API and formulations, and also manufacturing process intermediates if required. In addition to developing these key release tests we can support impurity profiling, using a range of forced degradation techniques and employing peak isolation, NMR, MS and MALDI-TOF analysis to identify degradants.
We have a wide range of ICH stability store conditions on site for short and long term stability studies of API, manufacturing batches and final dose forms, and can support all associated study management activities including protocol writing and reporting. As final batches are manufactured, either for clinical trials or full commercial launch we can meet the analytical challenges and as volumes grow and can transition the work from our Bradford site to our Group high capacity laboratories in Manchester.
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