Manufacturing process research and development, and optimisation for intermediates and active ingredients
Our synthetic chemists at EPP can conduct R&D studies to identify the most cost-effective way to manufacture a compound and find the best synthetic route selection to a target compound. This incorporates the supply of intermediate and target compound reference standards to enable purity characterisation; assistance in the sourcing, costing and availability of key raw materials; compilation and full disclosure of the developed process.
Trial (kilo) scale batch manufacture of intermediates and active ingredients (non-GMP)
We manufacture Active Pharmaceutical Ingredients (APIs) and advanced pharmaceutical intermediates, from milligram to kilogram scale, for non-clinical development purposes only i.e. non-GMP. We can also undertake key development activities enabling our clients to overcome technical challenges of progressing laboratory scale discovery projects to full scale production.
Starting from first principles, either literature and patent searches and/or discovery laboratory results, we can undertake process research, development and optimisation of manufacturing processes, followed by trial batch manufacture of APIs and advanced pharmaceutical intermediates (non-GMP).
We can arrange the provisional costing, raw material sourcing and full technology transfer to support the translation of in-house developed processes for the manufacture of APIs and pharmaceutical intermediates to full production scale at selected third party or client GMP compliant manufacturing facilities.
We can undertake a full literature search for known synthetic routes, physical, spectroscopic, analytical and stability data associated with known fine chemical intermediates and pharmaceutical products, which include known and potential related impurities.
We compile a comprehensive technical report based on rigorous examination of abstract, primary, patent and secondary literature sources. This service can be extended to include known toxicology, pharmacology and environmental impact of specific target compounds, or classes of compounds, as part of a client’s hazard assessment or patent defence strategy.
Expert technical support for regulatory submissions and IP protection
In addition to our literature searching/reporting service, we offer laboratory based synthetic expertise to help facilitate extension of the scope of patent applications, or to form the basis of an independent technical challenge to, or defence of, existing patents.