Drug Product

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We support both oral and parenteral drug product development and manufacturing for peptide drugs. Scroll down to find out our oral solid services below.

Our state-of-the-art injectable formulation development and manufacturing platform is located at Wuxi City site, China. To meet various needs from our global customers, we also have high potency injectable manufacturing line in Wuxi city site.

Our 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 fully enclosed isolation systems and automated filling lines.

Drug Types

Dose Forms

Filling Formats

Various Products

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.

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.

Formulation Development

The parenteral pre-formulation, formulation and analytical teams are located in Shanghai Waigaoqiao site and Wuxi city site, supporting 60+ compounds in 2023 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 R&D labs for drug product with OEL limit of 10 ng/m³.

We support all types of dosage forms and filling formats.

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 3 production lines are featuring fully enclosed isolation systems and automated filling lines, and we support high potency injectable 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