Oligonucleotide Process Development
Process Development and Optimization
With 100+ professional team members and high quality synthesis/purification equipment (e.g., multiple UPLC-MS, tangential flow systems), we offer phosphoramidite monomer synthesis, carrier coupling, process development, and validation services, covering ASO, siRNA, Aptamer, and other nucleic acid drugs, support development of 20+ modified monomers (e.g., 2'-F/OMe/LNA) and delivery systems (e.g., GalNAc, cholesterol), meeting innovative drug customization needs. The team comprises 100+ professionals, with core members holding Doctoral degrees and 10+ years of oligonucleotide synthesis, pilot-scale, and production scale-up experience. Team leaders have both domestic and oversea education, with 10+ years of experience in oligonucleotide R&D and full industry chain operations.
The company has multiple nucleic acid synthesizers, purification systems, tangential flow desalination devices, and multiple UPLC/UPLC-MS units to meet diverse project demands.
Acquity UPLC H-Class Plus
AKTA Flux S
AKTA Pure150
Bio-Lab100
Bio-Oligo100
Bio-TFF100
Oligo Pilot 100 Plus
Waters Xevo G2-XS-QTof
Analytical Method Development and Validation
Equipped with NMR600, MHZ, UHPLC-PDA/MSMS, QTOF, and other high-precision instruments for impurity characterization, molecular weight determination, sequence verification, and comprehensive testing compliant with ICH and China/US pharmacopeia standards. Uses EMPOWER network chromatography systems and UNIFI mass spectrometry data platforms to ensure traceable electronic data, meeting FDA 21 CFR Part 11 requirements.
Formulation, Sterile Filling, and Lyophilization
Custom-built isolator filling system (investment: tens of millions) enables lyophilization and filling in Grade A clean environments, avoiding nucleic acid hygroscopic risks. Grade C clean zones and purified water systems ensure controlled environments, with single-batch filling capacity reaching 3,000 vials.
The Integrated Sterile Filing and Lyophilization System
Thanks For Your Interest!
For more details on how we can advance your innovative drug discovery, please contact us.
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