Oligo CDMO
Comprehensive Oligonucleotide Manufacturing Solutions
Delivering quality, scalability, and cost effectiveness across the full oligo development lifecycle.
End-to-End Oligonucleotide CDMO Services
Our vertically integrated oligonucleotide CDMO platform supports customers at every stage, from early discovery through late‑stage clinical and commercial supply. With deep expertise in analytical and process development, GMP manufacturing, and quality control, we deliver reliable, high‑quality APIs tailored to your program needs.
In-House Oligonucleotide Raw Materials
As a global leader in nucleic acid chemistry, Hongene supplies a comprehensive range of high-purity raw materials to support oligonucleotide manufacturing, from R&D to GMP production. By integrating raw material synthesis with our CDMO services, we ensure quality, speed, and supply chain security.
Our in-house portfolio includes:
- Phosphoramidites, PMOs and PNAs (standard and modified bases)
- Linkers, spacers, and solid supports
- Delivery ligands, including GalNAc
- An industry-leading catalog of reference standards and impurities
All materials are available in ISO grade and are fully traceable to support regulatory submissions.
Process & Technology Development
We advance solutions that meet the unique needs of today’s next‑generation therapeutics. Our capabilities cover a wide array of oligonucleotide modalities, including:
- siRNA (small interfering RNA)
- ASO (antisense oligonucleotides)
- Aptamers
- Oligonucleotide conjugates
- PMO and PPMO compounds
Our development approach emphasizes robust process design, cost efficiency, and smooth technology transfer, ensuring that processes translate seamlessly to GMP manufacturing with minimal rework or risk.
We continually invest in new technologies to enhance quality, streamline operations, and reduce time to clinic.
Advanced Analytical Development
Our analytical development team supports every phase of oligonucleotide development, from early method establishment to full validation and ICH-compliant stability studies. We work collaboratively with clients to enable seamless method transfer, robust regulatory documentation, and global filing readiness.
All analytical instrumentation is available in-house, enabling fast turnaround times, consistent data quality, and full control over method optimization.
We characterize raw materials, process intermediates, APIs and drug products to the highest standards of accuracy, reproducibility, and regulatory compliance.
GMP Drug Substance Manufacturing
We offer one of the world’s largest capacities for oligonucleotide synthesis and downstream processing. Our capabilities scale from millimolar research quantities up to multi‑hundreds of mmol commercial batches, with robust control strategies that ensure consistency and regulatory compliance.
Chemoenzymatic Ligation Platform
Our next-generation chemoenzymatic ligation platform enables scalable, high-purity synthesis of complex oligonucleotides through modular fragment assembly. This approach overcomes length and impurity challenges associated with traditional solid-phase synthesis, making it ideal for long or highly modified oligos.
Benefits include:
- Higher yields than traditional SPOS
- Improved purity through enzymatic selectivity
- Cost efficiency for high-volume programs
- Compatibility with siRNA, ASOs, and long RNA constructs
This platform is fully integrated with our GMP operations and analytical workflows and is actively supporting clinical-stage manufacturing for our partners.
Drug Product Manufacturing
We offer comprehensive drug product (DP) manufacturing services to complete the vertical integration. Our capabilities cover:
- Formulation development for oligonucleotides and conjugates
- Sterile filtration and aseptic filling into vials or syringes
- Labeling, packaging, and release testing under GMP conditions
All DP operations are fully integrated with our upstream API and analytical teams, ensuring a seamless transition from drug substance to final dosage form. This integrated model improves speed, reduces transfer risks, and supports global regulatory compliance.
Quality Control Excellence
Our dedicated QC organization ensures product integrity across all stages of the value chain. From raw materials to final APIs and drug products, our QC team applies rigorous testing protocols using state-of-the-art instrumentation to confirm product quality.
Global Regulatory Support
We support our partners through every stage of regulatory development, from preclinical documentation to global filings. Our experienced CMC and regulatory teams have contributed to successful regulatory submissions in North America, Europe, and Asia, across a range of oligonucleotide modalities.
Our services include:
- CMC strategy and technical writing
- IND/IMPD-enabling documentation
- Data package preparation and gap analysis
- Regulatory query support and lifecycle management
This integrated regulatory support ensures your program advances with confidence, on time, and on track for global compliance.
