Quality Control of
Oligonucleotides
Comprehensive CMC testing and Quality Control for synthetic oligonucleotides, supporting precision medicine initiatives from early development through GMP release.
Navigating Complex Chemistry
Oligonucleotide-based therapeutics are heavily transforming systemic treatment paradigms. Due to their specific mass architecture and extreme sensitivity, their chemical complexities introduce difficult analytical checkpoints.
BrownBiology Laboratory utilizes dedicated methodologies mapping oligonucleotides through high-resolution platforms. Leveraging custom extraction, validation, and stability modules, we securely quantify identity, sequence, and specific formulations.
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Core Structural Analysis Hub
Extracting holistic analytical profiles of synthetic constructs across pure APIs or complex carrier matrices.
Identity & Structure
LC-MS and HR-MS sequencing. Detection of shortmers, longmers, and chemical variants, separated prior to MS.
Content & Potency
HPLC-UV and LC-MS quantitative assays optimizing the specific separation of active oligonucleotides from degradation footprints.
Purity & Impurities
Chromatographic profiling checking for truncations, elongations or mutated species through long-term stability trials.
Formulation Profiling
Lipid quantification in LNPs via HPLC-CAD, DLS for aggregations, and microbiology checks spanning endotoxins.
The BrownBiology Infrastructure Advantage
Inspected & Trusted
Universally recognized, audited, and strictly GMP-certified. Providing transparent traceability protocols spanning global clinical workflows.
Cutting-Edge Platforms
Equipped with state-of-the-art DLS limits, ICP-MS, specific HR-MS sequencing arrays framing elite sub-molecular profiling.
Integrated Bio-CMC Support
Structuring long-term partnerships moving therapeutics entirely from bio-analysis to clinical viability testing within internal frameworks.