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Oligonucleotide CMC Development
Established platforms for ASO/siRNA/PMO/sgRNA, with control strategy designed to scale.
Early Alignment Supports Fast Delivery
Oligonucleotide CMC requires early decisions that account for chemistry, sequence, and modifications as processes scale. Getting these decisions right is key to avoiding rework later in development.
Our integrated CMC approach advances drug substance, drug product, analytical, and regulatory activities in parallel to support faster timelines and commercial supply.
In addition, leveraging established process and analytical methods for modalities such as ASO, siRNA, PMO, and sgRNA, development can progress efficiently without unnecessary rework as programs advance.
API Process Development and Manufacturing
We support oligonucleotide API development across solid-phase, liquid-phase, and ligation-enabled manufacturing. These capabilities allow us to address challenges such as long or difficult sequences, modified backbones, and non-standard chemistries.
Process options, including enzymatic ligation, PN bond formation, precipitation, stirred-bed processing, and thin-film evaporation, are applied selectively to manage yield, impurity profiles, and process robustness as scale increases.
Purification is supported by a range of technologies, including continuous flow chromatography, ion-exchange chromatography, reverse-phase chromatography, hydrophobic interaction chromatography (HIC), and membrane-enabled purification.
We operate a range of mid-scale to large-scale production lines to support oligonucleotide manufacturing across clinical and commercial stages.
Formulation Development and Manufacturing
Drug product development is closely linked to drug substance attributes. Formulation strategies are developed with an understanding of molecule stability, impurity sensitivity, and manufacturing constraints.
By aligning formulation development work with drug substance and analytical development, WuXi TIDES helps avoid late-stage issues related to stability, container compatability, or process transfer.
Advanced Analytical Capabilities
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Methods for highly modified and stereochemically complex oligonucleotides, including sequencing/identity confirmation and impurity profiling where standard approaches fall short
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Advanced impurity elucidation for hard-to-resolve profiles, leveraging HRMS and complementary LC–MS strategies
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Particle and foreign matter investigation using flow imaging (MFI) with confirmatory identification by IR/Raman/EDX
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Container closure integrity testing (CCIT) with quantitative methods (e.g., vacuum decay, HVLD) to support parenteral products
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Microbiological risk support, including endotoxin/bioburden testing and microorganism identification/strain typing for investigations
Regulatory Dossier Preparation
Our global regulatory dossier preparation teams have extensive experience in global filings for IND, IMPD, and NDA submissions with the US FDA, EMA, and China’s NMPA. By integrating CMC dossier preparation with our API and drug product development and manufacturing, we can expedite the timeline to IND and NDA.
Production Lines
Robust Supply Chain
Accelerated Timelines
Related Services
Oligonucleotide-Based Conjugates
Stage-Focused Solutions
Formulation Development
Drug Product Manufacturing
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