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This talk will describe the steps that a pharmaceutical CDMO takes to ensure that the correct solid form of an active pharmaceutical ingredient (API) is selected and developed. The talk will provide detail on the steps taken by development chemists to understand the risks and advantages of different solid forms of an API and the precautions taken to ensure that the correct form of the API is manufactured reliably and reproducibly, thereby ensuring end user or patient safety.
Dr Jonathan Loughrey is currently the Head of Physical Sciences for Almac. Jonathan graduated from the University of York with a 1st Class MChem in Chemistry, joining AstraZeneca then Solvay Pharmaceuticals (later becoming Abbott Laboratories), both as a process chemist, studying development to pilot scale controlled crystallisations and on-line quantitative identification of high risk polymorphic forms within drug substance batches. Jonathan left industry to completed a Ph.D. in organic chemistry at the University of Leeds under the supervision of Malcolm Halcrow and Michaele Hardie, followed by three postdoctoral appointments in the UK and USA. Jonathan then returned to the UK to join a boutique contract research provider for solid form screening and development of active pharmaceutical ingredients. Jonathan rose through the organization, eventually overseeing their global materials characterisation and solid form screening and development business function. In 2021, Jonathan joined Almac to oversee material characterisation, solid form screening for novel and patentable polymorphs, salts, and co-crystals, crystallisation process development, amorphous solid preparation, milling and micronisation, preformulation development, and early/Tox. dose formulation development for small molecules and peptides for a global client base of biotech and large pharmaceutical companies.