The Wuxi city site is an integrated drug product R&D and manufacturing campus, including 3 R&D labs, 3 oral solid plants, 1 parenteral plant and QC labs. Wuxi city is about 1-hour driving distance (75 km) to Changzhou (Small molecule, Oligonucleotide and peptide API process R&D and manufacturing site) which enables seamless collaborations between API teams and formulation teams for efficient, flexible, and high-quality solutions to global pharma and biotech customers.
Oral solid formulation development and manufacturing: 1 oral solid clinical-scale plant and 2 oral solid commercial-scale plants provide manufacturing, packaging, and labeling services supporting both tablet and capsule dosage forms.
Parenteral formulation development and manufacturing: Parenteral small molecule, oligonucleotide, and peptide formulation development as well as analytical testing and QC platform. Parenteral formulation manufacturing lines feature a fully enclosed isolator supporting various of dosage forms including solution, emulsion, suspension, and lyophilized powder with different filling format including vial, pre-filled syringe, and cartridge.
Lipid nanoparticle formulation development and manufacturing: LNP platform features multi-channel mixing technology for robust scalability and reproducibility with integrated formulation development, analytical, in vitro/ in vivo evaluation. GMP manufacturing line is fully validated and in use.
Wuxi city site has successfully passed inspections by US FDA, EMA, China NMPA and Brazil Anvisa since 2021.
