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Oligonucleotide CMC
Oligonucleotide Discovery
Oligonucleotide CMC
Oligonucleotide Conjugate
Oligo Monomer & Ligand
Analytical
API-Oligo
Drug Product
Analytical
API-PMO
CMC-Filing
WuXi TIDES has a dedicated oligonucleotide analytical team of scientists with extensive experience and expertise to support all oligonucleotide analysis at all development phases. Equipped with state-of-the-art instruments and located in the same site with API process development team, our oligonucleotide analytical service will streamline your oligonucleotide development with customized, flexible and integrated analytical solution.
Our Services Include
Method development and validation
Stability study: forced degradation study, accelerated and long-term stability study under R&D and GMP environment
Purity and Assay, residual solvents, moisture, sodium content, anion residual, oligonucleotide content, elemental impurities
Microbiology safety: endotoxin for limit and quantitation and bioburden for microbial limit test, microbe ID and strain typing
Oligonucleotide backbone composition by 31P NMR
Process related impurity identification: 2D UPLC coupled with Q-TOF HRMS
Identity by molecular weight and sequencing: UPLC Q-TOF and MALDI-TOF/TOF HRMS for accurate MW and sequence determination
Chromatographic Techniques
High Performance Liquid Chromatography (HPLC)
High Performance Liquid Chromatography coupled with Mass Spectrometry (HPLC-MS)
Ultra-High Performance Liquid Chromatography (UHPLC - available detectors: UV, CAD)
Ultra-High Performance Liquid Chromatography coupled with Mass Spectrometry (UHPLC-MS)
2D Ultra-High Performance Liquide Chromatography (2D-UPLC)
Gas Chromatography (GC)
Ion Chromatography (IC)
Mass Spectrometry Techniques
Electrospray Mass Spectrometry (ESI-MS Orbitrap & Q-TOF)
Matrix Assisted Laser Desorption/Ionization Mass Spectrometry (MALDI-TOF/TOF)
Tandem Mass Spectrometry Sequencing (Q-TOF, Orbitrap & MALDI-MS/MS)
2D Ultra-High Performance Liquide Chromatography coupled with HRMS (Q-TOF)
Mass Spectrometry Purity and impurity quantitation (Q-TOF, single quadrupole)
Gas Chromatography Coupled with Mass Spectrometer (GC-MS)
Spectroscopic Techniques
Infrared Spectroscopy (IR)
UV/VIS Spectroscopy
Tm (UV melting curve)
Circular Dichroism Spectroscopy (CD)
Nuclear Magnetic Resonance Spectroscopy (1H, 13C, 31P & 19F - NMR)
Other Techniques
Elemental Analysis (CHN)
Polarimetry
Osmolality
Titration
Osmolality
TGA
XRPD
Total Organic Carbon (TOC)
Total Viable Aerobic Counts
Endotoxins (LAL-test)
Heavy Metals
Hygroscopicity (DVS)
Molar extinction coefficient determination