Parenteral
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Our state-of-the-art injectable formulation development and manufacturing platform is located at Wuxi City site and Shanghai Waigaoqiao site in China. It provides integrated R&D and manufacturing solutions for all synthetic molecules, including small molecules, oligonucleotides, peptides and complex chemical conjugates. To meet various needs from our global customers, we also have high potency injectable manufacturing line, advanced nanotechnologies and various drug delivery platforms at Wuxi City site.
Our formulation development & analytical teams have rich 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.
Drug Types
- Small molecule
- Oligonucleotide
- Peptide
- Synthetic conjugate
Dose Forms
- Solution
- Emulsion / Suspension
- Lyophilized powder
- In-situ-forming hydrogels
- Advanced formulations (e.g., Liposomes, Lipid Nanoparticles, Nano Particles)
Filling Formats
- Vials
- Prefilled syringes
- Cartridges
- LDPE ampoule
Sterilization
- Sterile filtration
- Heat-moist sterilization
- Irradiation
One Stop Parenteral Drug Product Services
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 drugs 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 manufacturing.
Blow-Fill-Seal Aseptic Filling Line
We have one Blow-Fill-Seal (BFS) aseptic filling line at our drug product site in Wuxi City.
Designed for eye drops and inhalants, this BFS line handles volumes ranging from 0.1 – 10 mL, fills up to 200 units per minute, and has an annual capacity of 9 million units.
