Latest regulatory approval follows on the back of expansion plans announced during DCAT 2024

With peptides, oligos and peptide conjugates continuing to attract drug developer interest and industry capacity in short supply, WuXi AppTec last week reported its Changzhou site has been approved by Japan’s PMDA [Pharmaceuticals and Medical Devices Agency}.

The 3-day inspection was passed without any major findings and follows on from the continuing expansion plans announced late last month during DCAT.  The new investments cover several large sites, including the 169-acre active pharmaceutical ingredient (API) manufacturing facility in Taixing, alongside existing drug-product manufacturing facilities in Wuxi City, China, and Couvet, Switzerland, and forthcoming sites in Middletown, Delaware, and Tuas, Singapore.

Phase 1 of the Taixing site – which spans an initial 81 acres with nine manufacturing plants, three of which are now in use ­– has been operational since January 2024. Including the new site, the company’s total reactor volume for API production will increase to 3,773 m³ by the year’s end (2024).

In response to continuing demand-side pressure for peptides and GLP-1 drugs, WuXi TIDES [the company’s peptide unit] has also tripled its peptide manufacturing capacity. The company’s total solid-phase peptide synthesis (SPPS) reactor volume has reached 32.5KL, with plans to further enhance SPPS capacity in Taixing and at its upcoming Singapore site [Phase 1 will open in 2026]. Significantly, the CDMO reported during its DCAT presentation that it now supports some 48 peptide-based drugs in various phases from preclinical to commercial.

It was also confirmed that company’s oligonucleotide manufacturing capabilities, with 27 lines currently operational across two sites, supports over 160 projects. These include all the common modalities ASO, siRNA, and PMO, and is supported by a team of over 600 scientists.

Similarly, drug-product manufacturing continues to grow with the introduction of high-potency (HP) lines [occupational exposure limit OEL of 10 ng/m³] for both sterile injectables and oral solids including tablets and capsules. In fact, by the end of 2024, WuXi will have five aseptic filling lines suitable for sterile injectables, eye-drops, and inhalants. Meanwhile, at the company’s drug-product site in Couvet (Switzerland), plans are underway to double tablet and capsule production capacity, add a parenteral line, a lipid nanoparticle (LNP) platform, and a spray dryer.