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Oligonucleotides
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CDMO-CRO
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Established in: 2023
Production scale:
small
medium
large
Employees: 1000+
Expertise in Conventional, Complex, and Niche Chemistries
End-to-end Support from early development to Commercial Phases
Comprehensive Analytical Support Facilities
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Plants in:
Established in: 2016
Production scale:
small
medium
large
Employees: 200
PFAS-Free Peptides
Certified Quality & Sustainability with ISO 9000 certification and RSPO audited supplier & GMP
Specialized in APIs & Pharmaceutical Intermediates
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CDMO-CRO
Pioneering in advanced delivery technologies and development solutions.
Extensive global network ensuring supply chain resilience.
Tailored services across biologics, gene therapies, and pharmaceuticals.
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Drug Substance (CDMO/CRO)
Drug Substance CDMOs and CROs provide end-to-end solutions for pharmaceutical companies developing and manufacturing active pharmaceutical ingredients (APIs). These organizations offer critical support in R&D, process development, scale-up, and GMP manufacturing, enabling pharma and biotech companies to accelerate time-to-market while ensuring compliance with global regulatory standards.
Oligonucleotides
Oligonucleotide outsourcing focuses on synthesizing nucleic acid drug substance using solid-phase chemistry.
A pharmaceutical CDMO manages synthesis cycles, deprotection, purification, and analytical testing to deliver GMP-grade oligos.
Typical steps include coupling cycles, oxidation or sulfurization, purification, desalt, and drying.
Key constraints often involve sequence length, backbone chemistry, and sensitive modification handling.
Practical answers for buyers sourcing CDMO services for oligonucleotide drug substance manufacturing.
An oligonucleotide CDMO synthesizes and purifies oligo drug substance such as antisense or siRNA sequences.
Services include solid-phase synthesis, deprotection, purification, and GMP release testing.
Provide sequence length, backbone chemistry, modifications, desired purity, and batch size.
Include target markets, salt form, and analytical method expectations.
Many CDMOs support phosphorothioate backbones, 2' modifications, and conjugations.
Confirm availability of specific monomers and validated methods for your modification profile.
Common methods include ion-exchange chromatography, reversed-phase chromatography, and ultrafiltration.
The approach depends on sequence length and purity targets.
Some CDMOs offer annealing services for duplex oligonucleotides and siRNA.
Confirm controls for strand ratio and annealing efficiency.
Scale ranges from grams for early-stage programs to multi-kilogram GMP campaigns.
Provide forecasted demand to ensure capacity alignment.
Confirm GMP inspection history, cleaning validation, and analytics suited to oligo impurities.
Ask about documentation for regulatory submissions.
Identity, purity, and impurity profiling are critical, often via LC-MS and HPLC.
Confirm in-house method development and stability testing capability.
Yes, especially for parenteral delivery.
Ensure the CDMO has validated controls and testing aligned with your dosage form plans.
Pitfalls include incomplete specification of modifications, late changes to sequence length, and insufficient analytical methods.
Early alignment on chemistry reduces delays.
Yes, many support tech transfer with method equivalency and process documentation.
Provide detailed synthesis cycles and purification parameters.
Timelines depend on sequence complexity and modification availability.
Platform chemistries can shorten development, while new modifications take longer.
Many do, including GalNAc or lipid conjugations.
Confirm conjugation chemistry and analytical verification steps.
Filter by region, stage, and services, then confirm capability with your backbone chemistry and modifications.
Shortlist partners with strong analytical support.
What is oligonucleotide outsourcing (CDMO)?
When to choose a CDMO for oligonucleotides
Common buyer requirements
Oligonucleotide CDMO services FAQ
What does an oligonucleotide CDMO do for drug substance?
What should I include in an oligonucleotide CDMO RFQ?
How do oligonucleotide CDMOs handle modifications?
What purification methods are common for oligo manufacturing?
Do oligo CDMOs support duplex or annealed products?
What are typical scale ranges for oligonucleotide CDMO manufacturing?
How do I evaluate GMP readiness for oligonucleotide drug substance?
What analytics are critical for oligonucleotide CDMO services?
Are endotoxin and bioburden controls important for oligos?
What are common pitfalls in oligonucleotide CDMO outsourcing?
Can oligo CDMOs provide tech transfer support?
How long does oligonucleotide process development take?
Do oligonucleotide CDMOs handle conjugated oligos?
How do I shortlist oligonucleotide CDMO companies in this directory?
