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Oligonucleotide CMC

Oligonucleotide Discovery

Oligonucleotide CMC

Oligo Monomer & Ligand

Drug Product

API-Oligo

Drug Product

Analytical

API-PMO

CMC-Filing

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 peptide API site in Changzhou, providing an integrated oligo API and formulation development and manufacturing solution.

Sterile Injectable

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.

We plan to open 2 additional manufacturing lines by end of 2022, better supporting more customers for their fast growing oligo formulation development and manufacturing needs.  

Our analytical capability includes 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. 

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Lipid Nano Particle Platform

WuXi STA Lipid Nanoparticles (LNP) platform featured with novel multi-channel mixing n-port for its robust scalability and reproducibility. We can produce lipid nanoparticles with various assembly structures and the technology can support programs from R&D to commercial manufacturing.

Our modular designed GMP facility, along with analytical QC supports, provides both flexibility and scalability. Besides the oligo API, specific lipid and other functional excipient needed in LNP formulation can be also developed and manufactured.