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Commercial
Validated processes, commercial peptide and oligonucleotide supply at scale, and further capacity under construction.
Process validation
Process performance qualification is the stage that confirms a process is ready for commercial production.
Since 2019 we have run more than 30 PPQ campaigns and taken 16 new chemical entities (NCEs) through qualification with a hundred per cent success rate. Twelve of those were peptides — including fragments, linear peptides, peptide-drug conjugates, radionuclide-drug conjugates and peptide-PMO. Four were oligonucleotides, with 11 further programs in PPQ-enabling work.
Behind that sits an inspection history. Across WuXi STA and WuXi TIDES:
20
12
95
17
4
6
Commercial API manufacturing
We deliver more than 60 metric tons of commercial peptide product a year. On the oligonucleotide side, one program delivered more than 400 kilograms in nine months, across a hundred batches at 900 mmol scale, with PPQ-enabling studies and the PPQ campaign itself inside that window.
Process mass intensity
Commercial peptide manufacture at WuXi TIDES runs at a process mass intensity of 85 per amino acid, against a published industry average of 875.
That is roughly a tenfold reduction in material consumed per unit of product, which affects cost of goods, the size of the raw material supply chain a program depends on, and the environmental footprint of the process. It is the result of continuous purification and process design work.
Lifecycle management
A commercial process has to survive years of small changes without any of them re-opening the questions the filing already answered, and that depends as much on control of the supply chain as on the process itself.
Amidites and solid supports are made in-house, with multiple qualified sources for the key raw materials that are not. For an oligonucleotide program, that removes a single point of failure from the chain: a modified monomer with one supplier and a long lead time.
Capacity ahead of demand
Two further plants are under construction at Taixing for 2027, and one at Singapore for the second quarter of 2028. The Singapore site puts peptide and oligonucleotide manufacturing capacity outside China.
Capacity ahead of demand
Commercial peptide and oligonucleotide supply depends on the supply chain as much as on the chemistry: the amidites, the solid supports and the raw materials with a single qualified source determine how predictable supply is, which is why the critical inputs are made in-house.