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Home | Services & Solutions | Peptide | Development & Manufacturing | Drug Product
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. Till now, our oral dose platform supported over 900 preclinical to commercial drugs.
Our parenteral formulation development and manufacturing platform is located in Wuxi City, China, with multiple manufacturing lines producing over 70 million units per year. We have supported over 200 parenteral projects.
To meet the diverse needs of our global customers, we have high potency drug product manufacturing lines for both oral and parenteral dosage forms.
Parenteral Dosage Platform
Drug Types
- Peptide
- Synthetic conjugate
Dose Forms
- Solution
- Suspension / Emulsion
- Lyophilized powder
- Advanced formulation (e.g., Liposomes, Lipid Nanoparticles, Nano Particles)
Filling Formats
- Vial
- Prefilled syringe
- Cartridge
- LDPE ampoule
Sterilization
- Sterile filtration
- Heat-moist sterilization
- Irradiation
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 aseptic filling lines, featuring fully enclosed isolation systems and automated filling lines. Our total production capacity is 70 million doses per year.
Highlight in Parenteral Formulation and Manufacturing
- Flexible batch size
- Organic solvent compounding & hydrophobic filtration (e.g. DMSO)
- Extreme low fill volume
- High viscosity mixing and filling
- Elevated or cold temperature mixing
- Dissolved oxygen and headspace control
- Sterilization methods
– Sterile filtration / Moist heat sterilization
– Irradiation
We are experienced in all stages including multiple phase III and commercial projects with 100% success rate of PPQ campaigns.
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 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.
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.
Clinical Supply Service
Related Resources
WuXi TIDES Brochure: CRDMO Platform for Oligonucleotide, Peptide and Complex Conjugate
Peptide API & Drug Product Facility Virtual Tour
Case Study: PDC Drug R&D and Manufacturing in 9 Months
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. Till now, our oral dose platform has supported over 900 preclinical to commercial drugs.
Both of the following approaches for oral peptide development are supported by our oral solid platform:
- Approach 1: oral delivery (absorption through the GI) – Preferred
- Approach 2: sublingual delivery (absorption through the lymphatic uptake and sublingual mucosa)
With the understanding of the drug’s physical/chemical and biopharmaceutical properties, we apply the following strategies for oral peptide formulation:
- Permeation enhancers
- SMEDDS (lipid-based formulation)
- Others (solid LNP, etc.)
We have developed and manufactured over 10 oral peptide formulations for clinical studies using various permeation enhancers.
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.
