WuXi TIDES has a dedicated analytical team with extensive experience and expertise in oligonucleotide analysis across all development phases from pre-clinical development to commercial manufacturing, covering both drug substance and drug product.

Equipped with state-of-the-art instruments and co-located with the API process development team, our oligonucleotide analytical service streamlines your oligonucleotide development process with a customized, flexible, and integrated analytical solution.

Analytical Development

Drug Substance Specific Analytical Services

Drug Product Specific Analytical Services

QC1 Analytical

Quality Control

Special Capabilities

NMR 600MHz Analytical
QC1 Analytical

Key Equipment

Case Study 1: Purity and Impurities by LC-UV-HRMS (tRNA/gRNA)

OligoAnalyticalCaseStudy1 Analytical

For the impurites that are hard to be separated from or co-eluting with FLP in HPLC-UV, MS purity is utilized for the qualificaiton and quantitation of impurities in tRNA, sgRNA PMO/PPMO and ASO analysis. 

Case Study 2: Purity and Impurities by LC-UV (sgRNA-100mer)

OligoAnalyticalCaseStudy2 Analytical

Evolution of resolution of HPLC purity method for sgRNA. From separation capability of n-8 and n+4 impurities initially to n-2 and n+1 impurities by current method at WuXi TIDES.

Case Study 3: Sequencing of PPMO

OligoAnalyticalCaseStudy3 Analytical

The determination of the Peptide-PMO sequence involves sequencing both the peptide and PMO components of the PPMO, as well as the conjugation process between the two intermediates.

Case Study 4: Systematically Screen Purity Methods for Improved Resolution

OligoAnalyticalCaseStudy4 Analytical

Both Ion-Exchange Chromatography (IEX) and Reverse-Phase HPLC (RP-HPLC) are utilized for the purity and impurity analysis of PMO product. These orthogonal chromatography techniques provide an accurate depiction of the product’s quality. 

  • WuXi STA has ability to screen methods systematically to get a better purity method with more resolved impurity peaks.
  • IEX purity method and RP purity method display different impurity profiles.
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