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Oligonucleotide CMC

Oligonucleotide Discovery

Oligonucleotide CMC

Oligo Monomer & Ligand

Analytical

API-Oligo

Drug Product

Analytical

API-PMO

CMC-Filing

WuXi STA 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

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)

HRMS

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)

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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)

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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