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Oligonucleotide-based therapies are revolutionizing the treatment of genetic diseases, cancers, and rare disorders. These short DNA or RNA sequences require complex chemistry, precise manufacturing, and strict regulatory compliance — making oligonucleotides CDMO companies essential for biotech and pharma developers.
Specialized oligonucleotides contract manufacturing partners provide the infrastructure, technical know-how, and quality systems necessary to produce antisense oligonucleotides (ASOs), siRNAs, aptamers, and other advanced nucleic acid-based therapeutics at clinical and commercial scale.
Not all CDMOs are prepared for the unique challenges of oligonucleotide synthesis and purification. When evaluating oligonucleotides CDMO companies, key criteria include:
Synthetic capability: Can they produce phosphorothioate, gapmer, or LNA-modified oligos?
Scalability: Do they offer gram-to-multi-kilogram scale synthesis suitable for clinical and commercial needs?
Purification technologies: Expertise in HPLC, ion exchange, and ultrafiltration specifically for oligos
Analytical rigor: Ability to test identity, purity, sequence fidelity, and residual solvents
GMP readiness: Do they support GMP manufacturing and regulatory documentation for global filings?
Experience with delivery formats: LNP-formulated, PEGylated, or conjugated oligonucleotides
Choosing a CDMO with deep oligo-specific expertise ensures smoother development, fewer surprises, and a faster path to patients.
Trusted oligonucleotides contract manufacturing partners typically offer:
Solid-phase synthesis of DNA, RNA, and chemically modified oligos
Process development and optimization for yield, purity, and cost efficiency
Purification and desalting using ion-exchange, reverse-phase, and size-exclusion chromatography
Conjugation with lipids, peptides, or GalNAc moieties for targeted delivery
LNP formulation and sterile filtration for injectable formats
GMP manufacturing for Phase I–III and commercial batches
Analytical testing: LC-MS, UV spectroscopy, CE, and endotoxin testing
CMC documentation and regulatory support for oligonucleotide submissions
These services are designed to meet the technical and regulatory demands of modern nucleic acid therapeutics.
Working with leading oligonucleotides CDMO companies offers strategic advantages:
Faster development timelines with proven oligo synthesis platforms
High purity and reproducibility through validated, scale-ready processes
Cost-efficiency via integrated synthesis, purification, and analytics
Regulatory compliance across EU, US, and Asian markets
Innovative capabilities for custom chemistries and targeted delivery approaches
These benefits are critical in the race to advance oligo-based treatments from concept to clinic.
53Biologics: CDMO specialized in decoding biologics production, from DNA to proteins, providing from preclinical to cGMP manufacturing. [See CDMO profile]
Shilpa Biologicals: CDMO which support Process Development, Gene to Cell Line Development to GMP to Formulation Development, Analytical Development, Process Development, Drug Substance, Drug Product, Fill-Finish and Packaging. [See CDMO profile]
HIPRA BIOTECH SERVICES: End-to-end internal capabilities from cell line development to commercial manufacturing. [See CDMO profile]
At MAI CDMO, we specialize in helping biopharma companies connect with experienced oligonucleotides CDMO companies that fit your synthesis, scale, and regulatory needs. Whether you’re developing an ASO, siRNA, or innovative nucleic acid conjugate, our network of oligonucleotides contract manufacturing experts will help bring your molecule to market faster.
Looking for a trusted oligo manufacturing partner? Contact us today and find your perfect CDMO match.
If you have any questions or suggestions, click here. We will be happy to assist you.