We support both oral and parenteral drug product development and manufacturing for peptide drugs from preclinical to commercial stages. 

Our oral solid formulation development and manufacturing platform is located at sites in Shanghai Waigaoqiao, China; Wuxi City, China; Couvet, Switzerland; and San Diego, USA. 

Our parenteral formulation development and manufacturing platform is located in Wuxi City, China, with multiple manufacturing lines producing over 42 million units per year. 

To meet the diverse needs of our global customers, we have high potency drug product manufacturing lines for both oral and parenteral dosage forms in Wuxi City.

Parenteral Dosage Platform

Drug Types

Dose Forms

Filling Formats

Sterilization

 

Our parenteral formulation development & analytical teams have extensive experience in injectable drug development from preclinical studies through clinical trials to commercial launch, with 60,000+ characterization tests yearly. 

We support a variety of dosage forms and filling formats for injectable drugs with 5 production lines, featuring fully enclosed isolation systems and automated filling lines. Our total production capacity is 70 million doses per year.

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Our peptide drug product platform offers a comprehensive formulation service for oral solid and injectable dosage forms. The formulation teams are supported by more than a thousand of scientists and state-of-the-art facilities at our integrated drug product R&D and manufacturing facilities at Wuxi city, Shanghai Waigaoqiao site in China.  Both two sites are within 2-hour drive to our peptide API site in Changzhou, providing an integrated peptide API and formulation development and manufacturing solution.

Oral Solid

Our oral solid platform provides a variety of dosage forms including tablets, capsules, powder, granules, liquid in bottle, liquid filled hard capsules and softgels with billions of doses annual capacity. In 2022, the team evaluated 2,498 molecules in preformulation studies, delivered 2,815+ clinical batches and worked on 45+ late phase and commercial projects. Read more

Sterile Injectable

Our injectable formulation development teams consist of experienced scientists, supporting various dosage forms – solution, emulsion/suspension, lyophilized powder and liposome in vial, pre-filled syringe and cartridge.
Our injectable manufacturing line is wholly automated in a full isolation system, designed to minimize human interventions and eliminate contamination to ensure high product quality. Read more 

High Potency Injectable Drug

The high potency sterile injectable manufacturing line is located at the drug product site in Wuxi City, China. Its Occupational Exposure Limit (OEL) is 10 ng/m3.

The fully enclosed isolation systems and automated filling machines minimize both microbial contamination and cross-contamination risks. The line has two 20 m2 lyophilizers and supports liquid and lyophilized vials of various specifications.

This line can efficiently perform the filling of up to 200 units per minute, achieving an annual capacity of over 12 million units.

LNP plant

Lipid Nanoparticle Technology

Lipid Nanoparticle (LNP) is a novel drug delivery system for oligonucleotide drug to overcome its delivery challenges, such as providing protection against serum nucleases, eliciting an immune response, targeting specific cell or tissue.

Overcome delivery challenges and accelerate your oligonucleotide drug projects with WuXi STA’s end-to-end LNP services, covering lipid discovery, formulation & process development, analytical development, and GMP clinical and commercial manufacturing.

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Formulation Development

The parenteral pre-formulation, formulation and analytical teams are located at Shanghai Waigaoqiao site and Wuxi City site, supporting parenteral projects from preclinical studies through clinical trials to commercial launch, spanning all synthetic molecules, including small molecules, oligonucleotides, peptides and complex chemical conjugates.

In addition, we also have high potency injectable labs with OEL limit of 10 ng/m3.

We support all types of dosage forms and filling formats.

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Developability & Formulation Research (DFR)
Manufacturing

The state-of-the-art parenteral drug product manufacturing facilities are in Wuxi City drug product site in China and will be expanded to our Couvet site in Switzerland and Middletown Delaware site in the US.

We support various dosage forms and filling formats at any scale from preclinical to commercial manufacturing.  We have 5 production lines are featuring fully enclosed isolation systems and automated filling lines, and we support high potency injectable drug product.

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Parenteral Formulation Manufacturing Line 1 Drug Product
Clinical Supply Service
Our Clinical Supply Services (CSS) provide a fast, flexible and reliable supply of materials for your clinical trials at any stage (from Phase I to Phase IV). Utilizing our integrated CMC platform which includes services for both drug substance and drug product development, we offer our clients a seamless transition from process development and pre-formulation studies to drug product manufacturing, packaging, labeling and distribution to clinical sites globally. To add, our clinical supply services support both oral and parenteral drug products with various dosage forms and packaging solutions. In 2023, our CSS teams supported both open-label and blinded studies from phase I to IV and executed hundreds of clinical protocols. Read more
clinical service supply thumb Drug Product

Related Resources

Oral Solid Dosage Platform

We support various oral dosage forms from pre-formulation to commercial manufacturing, including tablets, capsules, lipid formulation, powder and granule, liquid-in-bottle. With over one thousand of formulators & analytical scientists, we work with thousands of clients every year to accelerate their projects for global patients.

  • Formulation ready in 8 Weeks with only 1 g peptide API required
  • Over 10 oral peptide formulations developed

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oral solid

High Potency Oral Drug

We have established high potency oral solid dosage manufacturing facilities in Wuxi City. Wuxi City site supports high potency oral drugs with formulation development services and drug product manufacturing services with our global high standards.

Our high potency oral drug manufacturing plants feature fully enclosed production system with automated equipment. Its Containment Performance Target (CPT) meets the control requirements of Occupational Exposure Limit (OEL) as low as 10 ng/m3. We offer multiple formulation processes, including wet and dry granulation, capsule filling, tablet compression, and coating. Our production capacity is 600 million doses every year.

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