Our formulation team is supported by more than a thousand of scientists and state-of-the-art facilities at our integrated drug product R&D and manufacturing facilities in Wuxi city and Shanghai Waigaoqiao site in China. Both two sites are within 2-hour drive to our oligonucleotide API site in Changzhou, providing an integrated oligonucleotideAPI and formulation development and manufacturing solution.
Our injectable formulation development team consists of a team 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.
Currently, we have the injectable production capacity of 32 million units per year, which will be expanded to 42 million unit in 2024.
Lipid Nano Particle Platform
Lipid Nanoparticle (LNP) is a novel drug delivery system for oligo drug to overcome its delivery challenges, such as providing protection against serum nucleases, eliciting an immune response, targeting specific cell or tissue and etc. Our LNP platform features novel multi-channel micro-mixer for its robust scalability and reproducibility. Lipid nanoparticle with various assembly structures can be assembled by developing formulation and controlling process. Projects can be quickly promoted from R&D to GMP clinical and commercial manufacturing phases utilizing our strong LNP technology platform and proprietary technology experience. It is worth mentioning that services of synthesizing and manufacturing of oligo and specific functional lipids (such as ionizable lipids and PEGylated lipids) can be also provided by us. In conclusion, WuXi STA LNP platform is an end to end platform, which integrated CMC development and manufacturing services for drug substance, drug product and analytical support.
For the location of the LNP platform, R&D site is located in Shanghai Waigaoqiao, while LNP manufacturing plant located in Wuxi City. Professional analytical QC and QA teams supporting the whole process are also based in Wuxi City.
LNP R&D Lab
The LNP R&D lab equipped with multi-channel micro-mixing system, different scale of Tangential flow filtration (TFF) system, sterile filtration system and analytical equipment. Other mixing technologies are also available, such as MIVM, microfluidics, Precision Nano System and LNP extrusion systems. LNP feasibility study, formulation development and process development are carried out in R&D labs. The professional team with extensive experience can accelerate the project from R&D to GMP manufacture.
LNP Manufacturing Plant
This new modular designed LNP manufacturing plant in Wuxi City integrates multi-channel chip, micro-mixer system, and complex preparation system into a multi-channel micro-mixer core LNP manufacturing platform, offering significant advantages in drug-loading, liposome particle size control, and encapsulation efficiency. In addition, the modular design provides greater processing flexibility, enabling this platform to serve a wide range of manufacturing scales from 10-50 L per batch.
Analytical support includes but not limited to analytical method development and validation, in-process control and release, raw material, excipient, and packaging release, extractable and leachable (compatibility) study, ICH-compliant stability study.