We partner with you at every step of the drug development process—from method development, transfer, and validation to ICH stability studies to support CMC documentation for regulatory filings. Our team has extensive experience managing the specialized challenges of oligonucleotide analysis, including raw materials, intermediates, adjuvants, and APIs.
Flexible, phase-appropriate development
We develop customized methods for your oligonucleotide or can perform cGMP method transfers from other labs. For early phase projects, methods are verified to assess specificity and key performance indicators such as accuracy, precision, and robustness. For later phase projects, methods are validated as required prior to ICH stability testing and process validation. We also offer impurity testing by HRAMS.
We use state-of-the-art liquid chromatography and electrospray ionization mass spectrometry (LC-ESI-MS/MS) to sequence oligonucleotides. While oligonucleotides up to 30 bases are typically confirmed with 100% coverage using the standard approach, oligonucleotides over 35 bases are subjected to specific enzyme digestions followed by LC-ESI-MS/MS. Our staff has experience sequencing highly modified oligonucleotides.
Commitment to quality
To ensure the integrity of our facility and your products, our Quality Control team performs environmental monitoring; raw material, in-process and final product analysis; and stability testing under the ICH requirements. Most API and intermediate release testing is performed onsite, and offsite testing facilities are audited and approved under our quality management system.