New Molecule — Pilot to Commercial Manufacturing
Pilot trial into routine production
Customer Requirement
Move a new agrochemical technical from pilot success toward routine commercial production with a defined specification and launch timeline.
Technical Challenge
Pilot yields were acceptable at 50 L, but heat transfer, agitation and downstream crystallisation behaviour were not yet proven at multi-KL scale.
Chemistry
Multi-step synthesis with exothermic stages and a final crystallisation / drying sequence defining the commercial particle form.
Required Equipment
Jacketed reactors with verified heat-removal capability, crystallisers, centrifuges and vacuum drying aligned to the specification.
Facility Selection
A site was qualified for pilot-at-scale (500 L–1 KL), then re-evaluated for 3 KL commercial runs once trial batches met impurity and physical property targets.
Scale-Up
Structured scale-up: 50 L → 500 L trial → engineering review → 3 KL commercial with unchanged critical process parameters.
Manufacturing
Routine commercial lots after three consecutive trial batches met COA and physical property requirements.
Quality
In-process IPCs, QC release testing, stability pulls on early commercial lots and batch documentation package for customer audit.
Result
The molecule progressed from pilot to commercial manufacturing with equipment and quality requirements defined before routine supply — reducing launch risk for the customer.
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