www.conceptlifesciences.com).  This sits us alongside some other interesting companies within CLS such as Peakdale ">



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Laboratory Description:

Agenda1 is part of the Concept Life Science (CLS) group (www.conceptlifesciences.com).  This sits us alongside some other interesting companies within CLS such as Peakdale Molecular (www.peakdale.co.uk) who offer a range of specialist discovery, chemistry and synthesis services and CXR Biosciences (http://www.cxrbiosciences.com) who provide tailored pre-clinical services in the areas of investigative & mechanistic toxicology, exploratory & discovery toxicology, PK & metabolism and dermal absorption.
CLS plan to add other companies to support companies on the drug development pathway from "concept to the clinic door".

As an MHRA cGMP-certified laboratory Agenda1 has been involved in many programs to support CMC activities.   An approved CMC dossier is always the work of a wide range of professionals, often comprising an in house team and external professionals working together. The CLS group can help at a number of points in that process.  

On the manufacturing side, our team at Peakdale Molecular have many years' experience developing and optimising API synthesis routes, using a streamlined Design of Experiments approach to maximize data output. They are skilled in robustness and stress testing thus help to establish the critical Quality by Design parameters at this key stage in manufacturing process development. Once the synthesis route is clear at the 50 L level a state of the art "micro plant" development suite is used to manufacture demonstration batches for technology transfer.

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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67 Listerhills

Bradford, West Yorkshire BD7 1HR United Kingdom



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