API Drug Substance Development & Manufacturing
Taking a drug substance from a literature route to a validated process that produces the same material, batch after batch, for years.
Most API programmes do not fail on chemistry. They fail on the gap between a route that works once in a flask and a process that works every time in a six thousand litre reactor, with the impurity profile controlled, the cycle time affordable and the operators safe.
Closing that gap is the work.
What we take on
We work on small-molecule drug substances and their advanced intermediates. Typical engagements start at one of three points:
- You have a published or patented route and need it made at scale, reliably and at a defensible cost.
- You have an existing supplier and need a qualified second source with its own dossier.
- You have a target and no settled route, and need the chemistry worked out from scratch.
Controls that run through every stage
Impurity control strategy
Process-related impurities and degradants identified, tracked and controlled to ICH Q3A limits, with genotoxic impurity assessment where the chemistry warrants it.
Process safety
Reaction calorimetry and thermal hazard assessment before any exotherm goes to scale. Scale-up does not proceed on the assumption that it will be fine.
Solvent and waste strategy
Solvent selection reviewed for recoverability and effluent load, because a route that cannot be run cleanly cannot be run cheaply either.
Critical parameter definition
The handful of parameters that actually move the outcome are identified and given proven acceptable ranges, rather than locking down everything indiscriminately.
Polymorph and particle control
Crystallisation developed for consistent form and particle size distribution, which is usually where downstream formulation problems originate.
Dossier-ready records
Development is documented as it happens, in a form that supports a filing. Reconstructing a development history two years later is nobody's idea of a good time.
Within this service
Stage Gates for API Development
The decision points a programme passes through, and what has to be true at each one.
Read moreProcess Development
Route optimisation, scale-up and the engineering behind a reproducible process.
Read moreCommercial Manufacturing & Lifecycle
Routine supply, change control and continued process verification.
Read moreSpeak to someone who knows the answer
Technical, regulatory or commercial - your enquiry reaches a person who works on this, not a shared inbox.