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Tianjin, China

Discovery oligo, amidite, GalNAc

WuXi AppTec (Tianjin) started to operate in 2007, currently it has state-of-the-art synthetic and analytical R&D lab, with a few thousands of experienced chemists and analytical scientists

Tianjin site has a team of experienced chemists for oligo synthesis. Our services includes customized synthesis, process development and manufacturing based on FFS and FTE model. The team can work on various categories of oligo, such as siRNA, miRNA, sgRNA, ASO, PMO, Aptamer. Besides that, the process R&D team has abundant experience on manufacturing amidite, GalNAc, NTP and Cap reagent for DNA and RNA. 

Tianjin Site has dedicated analytical team to support QC and purification work of oligo synthesis. The team can support development and manufacturing projects under ISO 9001 standard.

Address:

168 NanHai Road,10th Avenue, TEDA, Tianjin (300457) China.


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Changzhou, China

Oligonucleotide and conjugate
process development & manufacturing

Changzhou site is a fully integrated API R&D and cGMP manufacturing campus providing a unique one-site solution, including small molecule, HPAPI, oligonucleotide, peptide and complex chemical conjugate, through preclinical and clinical development to global commercial launch. Now the site has 11 plants, 1,292m3 total reactor volume.

By the end of 2022, the site will become a 74 acre campus including 2 R&D centers, 15 plants with 1,927 m3 total reactor volume.

Currently with a few hundreds of scientists dedicated to oligonucleotide CMC, the site has built strong chemistry capability of process R&D for synthesis of oligonucleotide, ligand and linker as well as various oligo-based conjugates including PPMO, Oligo-GalNAc, Oligo-Toxin, Oligo-Antibody, Oligo-Peptide, etc.

The site has also built large oligonucleotide manufacturing capacity up to 6 mol for solid phase oligonucleotide synthesis. 

Address:

589 North Yulong Road XinBei District, Changzhou, 213127, China

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Singapore

Oligonucleotide API process development & manufacturing

WuXi AppTec, a leading global provider of R&D and manufacturing services that enable the global pharmaceutical and healthcare industry, announced a plan to build a new 50-acre R&D and manufacturing site in Singapore on July 19, 2022, totally 7 plants in plan. The company intends to invest up to S$2 billion (approximately US$1.43 billion) to construct and operationalize the site, which aims to further enable global partners to advance healthcare innovations. The investment is expected to be made in stages over the next 10 years, depending on the company's business needs.

In Phase I project, we plan to build 2 plants for small molecule API with 350+ m3 TRV and 1 plant for oligonucleotides, peptides and complex chemical conjugates. It's expected to start operation in 2026. 

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Taixing, China

Oligonucleotide and conjugate API manufacturing

With a total area of 170 acres, the Taixing site is designed to support global partners with integrated API process R&D and manufacturing from preclinical to commercial stages. The first phase of the project, with an area of about 53 acres, is expected to be fully operational in 2025, with an annual capacity of more than a hundred of metric ton of drug substance.

The first phase of the project also includes industry-leading new molecular modality platforms from laboratory to commercial scale, such as high potency APIs, oligonucleotides and peptides.

By 2023, we will have multiple commercial production lines for oligonucleotide with 4+ mol per synthesis run and dedicated lines for PMO with up to 300L synthesizers.

Address:

Taixing Economic Development Zone, Jiangsu China

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Shanghai, China

Oligonucleotide preformulation and formulation Development

Shanghai Waigaoqiao site is our headquarter with a comprehensive formulation R&D and manufacturing platform, from pre-formulation to commercial manufacturing, including solid-state development, pre-formulation and formulation development and commercial manufacturing, along with analytical and QA support.  

The site provides pre-formulation and formulation development for oligonucleotide. 


Address:

288 Fute Zhong Road Waigaoqiao Free Trade Zone

Shanghai 200131, China

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Wuxi city, China

Oligonucleotide formulation development & manufacturing

The Wuxi city site is an integrated drug product R&D and manufacturing campus, including one R&D center and two oral solid commercial-scale plants. The R&D center accommodates hundreds of scientists from oral dosage platform, sterile injectable platform as well as analytical testing platform. The two oral solid commercial-scale plants provide manufacturing, packaging, and labeling services. The newly opened R&D center includes oral, injectable and analytical platforms.

The parenteral formulation platform at our Wuxi city site is designed for vials, cartridges and pre-filled syringes with state-of-the-art equipment. And it supports the Lipid Nanoparticle(LNP) formulation development and manufacturing, more details to be found here.

Address:

8 Xinrui Road, Xin Wu District, Wuxi, Jiangsu, 214028, China

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Middletown, DE, USA

Oligonucleotide formulation development & manufacturing

In June 2021, WuXi STA announced that it will build a new pharmaceutical manufacturing campus in Middletown, Delaware US.  The 190-acre new facility in Middletown will feature space for testing laboratories; formulation R&D; and manufacture and packaging of oral solid pharmaceutical products and sterile products, which is expected to start operation in 2025.