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Pharmaceutical development is the progression of a new chemical compound found in early screening through to the later stages of clinical evaluation. The term includes the development of a
scaleable manufacturing process as well as refinement of the optimum physical form of the Active Pharmaceutical Ingredient.
Pharmaceutical development starts with an active compound that manifests the desired response in an assay. However in vivo (in the organism), the compound might not get to the point of action as
it so easily did in vitro (lit. in glass). Pharmaceutical development is needed to turn the compound into a form that is stable, is biologically available and can be made into an optimal formulation.
A balance is needed between the water solubility and lipophilicity (ability to dissolve in fats) characteristics of the drug. Onyx Scientific's scientists are especially skilled at turning a compound
with poor physical properties into one that can be crystallised and processed effectively. A rapid Salt screen can be conducted at Onyx and the results analysed with leading analytical methods (XRPD,
Raman spectroscopy, DSC, DVA, TGA). Candidate compounds can subsequently be selected and further optimised.
Onyx Scientific's pharmaceutical development service crucially integrates manufacturing expertise with solid-state expertise and is one of the few companies offering this combined service. We
operate a dedicated and highly experienced team of analysts and physical chemists who have at their disposal a diverse range of state-of-the-art equipment and facilities.
Scale up and production of kilo quantities of the drug under GMP conditions completes the early pharmaceutical development phase. We have successfully made almost 60 APIs to GMP standards for use
in trials.
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Lead optimisation
