News from DCAT Week 2022: WuXi STA Outlines Major Expansion PlansBy
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 their conjugates, as well as in its drug-product manufacturing operations. Yu Lu, Chief Business Officer and Head of New Modality Business, WuXi STA, provided an update at the DCAT Member Company Announcement Forum held on March 21, 2022 at DCAT Week 2022.
Within the company’s existing facilities, its expansion plans for its API business in 2022 are focused at its Changzhou and Shanghai Jinshan sites in China, and at its site in Wuxi City, China, for its drug-product operations.
WuXi STA’s Changzhou site is an integrated API process R&D and manufacturing site. In the first quarter of 2022, WuXi STA opened a new R&D center that can accommodate 950 scientists and two new plants with a total reactor volume (TRV) of 360 m3. In addition, the company plans toopen four more plants with a TRV of 635 m3 this year (2022). By the end of 2022, the Changzhou site will occupy 74 acres, consisting of two R&D centers and 15 plants with a total TRV of 1,927 m3.
Flow chemistry (i.e., continuous manufacturing) and biocatalysis are two key technology platforms for the company’s API business, and the company is expanding its capacity in these areas at its Changzhou and Shanghai Jinshan sites. The company’s flow chemistry technology covers 18 reaction types and was applied to more than 180 steps, including 18 commercial projects in 2021. To support increased demand, WuXi STA will expand its flow chemistry production capacity from the current 14 lines to 30 lines in 2022.
In biocatalyis, WuXi STA’s technology platform covers a one-stop process from enzyme engineering, enzyme screening, enzyme production, biocatalytic process development and production. In 2021, it successfully developed more than 50 biocatalytic processes and delivered more than 80 metric tons of APIs and intermediates. In January 2022, the company began the operation of two new 2,000-L fermenters for enzyme production to reach total fermenter capacity of 5,500 L.
The company is also expanding production capacity for its New Modality platform (oligonucleotides, peptides, and their conjugates). The company plans to expand the number of oligo production lines to more than 20 small-scale lines, three mid-scale production lines, and four large-scale production lines in the second half of 2022. Also, in the second half of 2022, it plans to increase its peptide production lines to 14 lines with two additional 1,000-L reactors. High-potency APIs (HPAPIs) represent another area of growth as a small-molecule therapeutic and in conjugation with oligos, peptides, or antibodies; the company is adding a second HPAPI plant at its Changzhou site, which will include a 3,000-L reactor.
On the drug-product side, in January of 2022, WuXi STA launched a multi-purpose parenteral formulation sterile fill–finish line at its site in WuXi City, China, and plans to add two more parenteral lines at the Wuxi site by the end of 2022. Its parenteral formulation facility is located in the same province as the Changzhou site to enable collaboration for end-to-end API, drug product, analytical, and regulatory CMC support for small molecules, oligonucleotides, peptides, and their conjugates.
WuXi STA also plans to expand its oral drug-product platform at its site in Wuxi City by providing more tablet and capsule capacity. In addition, the company is adding capabilities, including high-potency tablet and capsule lines and a continuous tablet manufacturing platform.