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Commercial API Manufacturing
Process validation, launch supply, and post-approval change for the commercial life of the product.
Why commercial capability is assessed at Phase I
At Phase I, commercial supply is a distant decision. It is still worth assessing, because moving an approved process to a different manufacturer means a technology transfer, comparability studies, and a post-approval change.
We supply more than 70 commercial products. Across all of them, on-time delivery is 100%, and the deviation rate on commercial batches is below 0.3%.
Process validation
We have taken more than 180 new chemical entities through process performance qualification since 2018 without a failure. Validation is the point at which every earlier shortcut becomes visible, which is why most of the work behind a successful PPQ is done in late-phase development.
Commercial supply
39,000+ drug substance batches a year, across 33 plants and more than 4,000 m³ of reactor volume. Batch sizes run from kilograms to metric tons, depending on the product.
Where the API is made
Our API network runs across North America, Europe and China, with a Singapore site scheduled for 2027. A commercial process can be sited at more than one of them.
A second manufacturing site is easier to design into a process during development than to add after approval, when it becomes a post-approval change.
Lifecycle management
Processes change after approval — a lower-cost starting material, a new market with different requirements, a yield improvement worth the filing effort.
Change control after approval
After launch, commercial supply becomes largely a change control question: a new market, a change of raw material supplier, a shelf-life extension. Each one is assessed against what the filing already says.
Post-approval changes are assessed by the organization that generated the original development data.