API Process Development
The evolution of the chemical synthesis of an API from laboratory to plant scale is a complex process, which is both specialised and intensive. Our experience and expertise in this area means that TopChem can offer our customers the option of outsourcing the development and optimisation of their process technology.
Scale-up facilities may be arranged either in our own FDA inspected GMP facility or in collaboration with a leading Irish GMP manufacturer from kilos right up to multi-tonne scale.
Some projects completed recently:
- Developed commercial process for a blockbuster API from an advanced intermediate sourced in India/China.
- Phase I Project: Replaced chromatographic separation of diastereomers with highly efficient crystallisation and slurrying protocol resulting in dramatic process cost reduction.
Building on our experience of API development we can supply reference standard impurities, metabolites and related research materials. Using our supply chain network we generally source advanced intermediates to facilitate rapid and cost effective supply of these materials