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Early Phase API Process Development
A route that runs now and is designed to hold through Phase III.
The early-phase trade-off
The fastest route to first-in-human is rarely the route that survives to commercial supply. A route chosen for speed alone usually has to be rebuilt later, with the comparability work that brings; a route optimized too early for the commercial process delays the IND.
Early-phase process development manages the trade-off: deciding which simplifications carry no cost at scale and which will have to be undone.
Timelines in weeks per step
Process development and manufacturing runs at about 2.5 weeks per step for the API, and 1.5 weeks per step for regulatory starting materials. The number of steps per route determines the timeline.
We have supported more than 2,000 molecules from preclinical through Phase II.
Route scouting
Before a route is committed, we look for the one that can be run at scale: fewer steps, safer reagents, controllable impurities, and starting materials that can be purchased.
That work includes isolating, characterizing and controlling process impurities, validating both the synthetic and analytical protocols, and running stress tests and safety evaluation before a step goes into a kilo lab.
Process development
Condition optimization, in-process controls, and the analytical methods that will stay with the molecule through to commercial supply. Our enabling technologies are available from the first campaign: crystallization and particle engineering, flow chemistry, biocatalysis, chemocatalysis, and preparative HPLC, SFC and SMB chromatography.
High-potency compounds are handled on the same platform, down to an occupational exposure limit of 10 ng/m³, and every enabling technology is available inside containment.
Preclinical and IND-enabling manufacturing
Toxicology supply, first GMP batches, and the CMC section that goes with them. Analytical development, stability and dossier preparation run in parallel with the chemistry.
Speed that holds at Phase III
A route that reaches IND quickly and cannot be scaled has to be reworked in Phase II, when any process change brings comparability data with it.
Route scouting is given the time the route needs, and the workstreams downstream of it, analytical development, stability and dossier preparation, run in parallel.