Stage Gates for API Development
Six decision points between a target molecule and validated commercial supply. Each one has an exit condition, and we do not pass a gate on optimism.
Stage gates exist so that a programme in trouble gets stopped early and cheaply, rather than late and expensively. The point of a gate is that it can be failed.
At each gate we produce a written position and you make the call on whether to continue, rework or stop.
The gates
| Gate | Question it answers | Exit condition |
|---|---|---|
| G1 — Feasibility | Can this be made, by us, at a sensible cost? | Costed route proposal, IP position reviewed, no known blocking hazard. |
| G2 — Route selection | Which of the candidate routes do we commit to? | One route selected on yield, safety, cost and freedom to operate, with the reasoning written down. |
| G3 — Lab lock | Does the chosen route reproduce at laboratory scale? | Three consecutive lab batches meeting draft specification, impurity profile characterised. |
| G4 — Scale-up | Does it survive a real reactor? | Pilot batch at representative scale, thermal hazard assessment complete, cycle time confirmed. |
| G5 — Validation readiness | Is everything in place to validate? | Methods validated, protocol approved, raw materials qualified, equipment released. |
| G6 — Commercial release | Can we supply this routinely? | Validation batches passed, dossier package issued, supply agreement and capacity confirmed. |
What a gate review actually involves
Both sides in the room
Your technical and regulatory people attend. A gate passed without the customer present is a status update, not a decision.
Written position, including the bad parts
The gate document states what did not work and what remains unresolved. A gate paper with no open risks is a gate paper nobody wrote honestly.
Rework is a valid outcome
Going back a gate is normal and costs far less than discovering the same problem during validation.
Speak to someone who knows the answer
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