Oligonucleotides / Non-GLP
Specialized analytical characterization and quality control services for active substances and therapeutic oligonucleotide products.
Therapeutic Oligonucleotides / Non-GLP
Specialized analytical characterization and quality control services for active substances and therapeutic oligonucleotide products.
Therapeutic oligonucleotides — including antisense oligonucleotides (ASOs), small interfering RNA (siRNA), microRNA mimics and inhibitors, aptamers, splicing-modulating oligonucleotides, and other modalities — represent one of the most innovative segments of the pharmaceutical pipeline. These complex synthetic molecules present analytical characterization challenges that require dedicated expertise, specialized chromatographic platforms, and in-depth knowledge of the regulatory framework.
The structural complexity of modern therapeutic oligonucleotides — which typically incorporate multiple backbone and base modifications to enhance stability, reduce immunogenicity, and improve pharmacokinetic properties — requires analytical methods specifically designed to characterize these modifications and distinguish the active substance from closely related impurities. Chromatographic resolution of species differing by as little as a single nucleotide requires state-of-the-art UHPLC platforms with ion-pair chromatography.
AMSbiopharma provides a comprehensive suite of analytical characterization and quality control services for therapeutic oligonucleotides, covering identity, purity, and sequence integrity — the fundamental analytical pillars required for any regulatory submission.
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Our catalog of services include
Oligonucleotide Exact Mass Measurement (Non GMP)
Exact mass measurement by high-resolution mass spectrometry provides the most definitive identity confirmation available for therapeutic oligonucleotides, delivering a precise molecular formula that confirms the number and identity of constituent nucleotides, backbone modifications, and any other chemical modifications incorporated into the active substance.
AMSbiopharma offers validated exact mass measurement services for therapeutic oligonucleotides using UHPLC coupled to high-resolution mass spectrometry under ion-pair chromatography conditions. Charge-state deconvolution software provides deconvoluted average and monoisotopic masses.
Key analytical capabilities:
– Exact mass determination with sub-ppm accuracy for therapeutic oligonucleotides
– Coverage of ASOs, siRNA, aptamers, and highly modified species
– High-resolution UHPLC-MS with ion-pair chromatography
– Charge-state deconvolution for intact oligonucleotide mass determination
– Applicable to phosphorothioate species, 2′ modifications, and other backbone modifications
– Identity confirmation data for CMC regulatory submissions
Oligonucleotide Purity and Impurity Identification
Purity assessment is a critical batch release and stability monitoring assay for therapeutic oligonucleotides, ensuring that the active substance meets its purity specification and that process-related impurities — including truncated sequences (n-1, n-2), deletion sequences, extended sequences (n+1), and other synthetic by-products — are within acceptance criteria.
AMSbiopharma provides validated UHPLC-based analytical services for purity determination and impurity identification, applying ion-pair reversed-phase chromatography with UV detection for quantification and mass spectrometry detection for impurity identification.
Key analytical capabilities:
– Purity determination by validated UHPLC-UV using ion-pair chromatography
– Chromatographic resolution of n-1, n-2, and n+1 sequence impurities
– Impurity identification by LC-MS for structural characterization
– Applicable to ASOs, siRNA, aptamers, and modified oligonucleotides
– Support for CMC development.
Oligonucleotide Sequence Confirmation
Sequence confirmation provides definitive identity verification for therapeutic oligonucleotides, ensuring that the active substance contains the intended nucleotide sequence and that all chemical modifications are present at the correct positions. It is a mandatory component of the identity characterization package for regulatory submissions.
AMSbiopharma provides validated sequence confirmation services using tandem mass spectrometry (MS/MS)-based approaches, generating fragment ion series that confirm the nucleotide sequence and localize chemical modifications throughout the entire length of the oligonucleotide.
Key analytical capabilities:
– MS/MS-based sequence confirmation with comprehensive sequence ion coverage
– Identification and localization of backbone and base modifications
– Confirmation of phosphorothioate linkages, 2′ modifications, and other backbone features
– Regulatory-grade sequence identity data for CMC submissions
– Support for short and long oligonucleotides
Oligonucleotide Stability and Degradation Analysis
Stability and degradation analysis for therapeutic oligonucleotides provides essential information for shelf-life determination, storage condition specification, and understanding of degradation pathways. ICH Q1-compliant stability programs require validated stability-indicating analytical methods capable of detecting the full range of degradation products.
AMSbiopharma provides validated analytical services for stability and degradation assessment, applying UHPLC and LC-MS/MS platforms to detect, quantify, and identify degradation products.
Key analytical capabilities:
– Validated stability-indicating UHPLC methods for formal ICH Q1-compliant stability studies
– Detection and quantification of degradation products
– Identification of degradation products and pathway elucidation by LC-MS/MS
– Applicable to active substance and drug product stability programs
– Coverage of hydrolytic, oxidative, and depurination degradation pathways