From DCAT Week 2023: WuXi STA Outlines Major Expansion Plans
WuXi STA, a subsidiary of WuXi AppTec, is proceeding with a major expansion plan in its global R&D and manufacturing network for small-molecule active pharmaceutical ingredients (APIs), oligonucleotides, peptides, and the conjugates, as well as in its drug-product operations. Yu Lu, Senior Vice President, Business Operations and Head of WuXi TIDES, at WuXi STA, provided an update at the DCAT Member Company Announcement Forum held on March 20, 2023, at DCAT Week.
WuXi STA is proceeding with expansions in its global R&D and manufacturing network offering API and drug-product R&D and manufacturing for small molecules, oligonucleotides, peptides and the conjugates. Within the company’s existing 14 facilities across the US, Switzerland, Singapore, and China, the company’s expansion plans in 2023 and 2024 are focused on its sites in Changzhou, Wuxi City, and Taixing in China and its site in Couvet, Switzerland. The company also highlighted news on its Singapore site and provided an update of its new site, currently under construction, in Middletown, Delaware.
The Changzhou site is an integrated API process R&D and manufacturing site, which has undergone recent expansion. The last phase of expansion, which included six API manufacturing plants, was completed between 2022 and the first quarter of 2023. The Changzhou 74-acre campus now has 1,848 chemists and analytical scientists and total reactor volume of 1931 m3. The Changzhou site also features API-enabling technology platforms, including flow chemistry and high-potency APIs (HPAPIs). The HPAPI facility, with an occupational exposure limit (OEL) of 10 ng/m3, is equipped with 10 m3 total reactor volume, including HPAPI reactors up to 3,000 L. The flow-chemistry platform at the site has 16 production lines that cover 20 reaction types, including photo reactions, hydrogenation, and electrochemistry.
Due to increased demand, WuXi STA consolidated resources in a new brand, WuXi TIDES, to provide end-to-end contract research, development and manufacturing services for oligonucleotides, peptides, and the conjugates across nine sites with more than 1,000 scientists. In oligonucleotides, the company now has six GMP solid-phase oligo synthesis (SPOS) production lines at its site in Changzhou. By 2024, the company will add more SPOS production lines. For peptides, the company plans to double its current solid-phase peptide synthesis (SPPS) total reactor volume from 10,490 L to more than 20,000 L. From a new technology capability perspective, in 2022, the company introduced biocatalysis (RNA synthesis) and thin-film evaporation for oligo production and continuous flow chemistry, and tangential flow filtration / precipitation for peptide production.
On the drug-product side, to support multiple molecular modalities, including small molecules, oligos, and peptides, in 2023, the company launched two parenteral commercial production lines at its site in Wuxi City, China, with capacity of 12 million units for a variety of dosage forms and filling formats. The site also launched a lipid nanoparticle (LNP) platform to provide integrated lipid discovery, formulation & process development, and GMP manufacturing services. Next year (2024), the site will launch a high-potency parenteral line with OEL of 10 ng/m3 and annual capacity of 10 million units. At the company’s site in Couvet, Switzerland, the company has a series of expansions planned. With a new dry-granulation line installed last year (2022), in 2024, the company plans to add a new wet-granulation line and double tablet and capsule production capacity. In the next two years, the company plans to add a parenteral line, a LNP platform, and a PSD-3 spray dryer.
The company is also expanding its footprint outside China. The company’s new site in Middletown, Delaware, is on track and is expected to open in 2026. Phase I construction includes formulation R&D and manufacturing as well as packaging, labeling, and distribution. The company is also proceeding with a new site in Singapore for API development and manufacturing. Phase I is expected to open in 2026, which includes an API R&D center and three manufacturing plants for small molecules, oligonucleotides and peptides and the conjugates.