UNIQ Trials
PK/PD & ModelingBioanalytical ServicesIND / Regulatory Package AuthoringOncologyHematologySmall MoleculePeptide
Quick answer
Outsourcing an oligonucleotide (ASO or siRNA) program means sourcing solid-phase synthesis, sequence and chemistry optimization, conjugation (GalNAc), LNP or delivery formulation, and a heavy analytical load: mass spec, anion-exchange and ion-pair HPLC, and impurity profiling. Specialist CRO and CDMO partners handle GMP oligo manufacturing and stability. On BioBridgeX you compare qualified suppliers free, as the neutral marketplace, and contract directly with the supplier you choose.
Oligonucleotide (ASO / siRNA) CRO and CDMO vendors (77)
Apeloa Pharmaceutical
Target ID & ValidationAssay Development & ScreeningHit IdentificationOncologyHematologySmall MoleculePeptide
TRiCBIO
Target ID & ValidationAssay Development & ScreeningHit IdentificationOncologyCNS / NeurologySmall MoleculePeptide
VCHP Clinical Solutions
Computational / AI-Driven DiscoveryPK/PD & ModelingPhase 1 / Early Clinical UnitOncologyHematologySmall MoleculePeptide
ChemPartner
Unclaimed · public records
CRO & CDMO · ADC / Bioconjugation, Medicinal & Synthetic Chemistry, Drug Substance: Biologics
ADC / BioconjugationMedicinal & Synthetic ChemistryDrug Substance: BiologicsOncologyImmunology & InflammationAntibody-Drug Conjugate (ADC)Small Molecule
NJ Bio
Unclaimed · public records
CRO & CDMO · ADC / Bioconjugation, Medicinal & Synthetic Chemistry, Assay Development & Screening
ADC / BioconjugationMedicinal & Synthetic ChemistryAssay Development & ScreeningOncologyAntibody-Drug Conjugate (ADC)Oligonucleotide (ASO / siRNA)
BSP Pharmaceuticals
Unclaimed · public records
CDMO · ADC / Bioconjugation, Aseptic Fill-Finish, Drug Product Manufacturing
ADC / BioconjugationAseptic Fill-FinishDrug Product ManufacturingOncologyHematologyAntibody-Drug Conjugate (ADC)Monoclonal Antibody (mAb)
Ajinomoto Bio-Pharma Services (Aji Bio-Pharma)
Unclaimed · public records
CDMO · ADC / Bioconjugation, Drug Substance: Biologics, Peptide / Oligo Synthesis
ADC / BioconjugationDrug Substance: BiologicsPeptide / Oligo SynthesisOncologyAntibody-Drug Conjugate (ADC)Monoclonal Antibody (mAb)
Synaffix (a Lonza company)
Unclaimed · public records
CDMO · ADC / Bioconjugation, Medicinal & Synthetic Chemistry, Process Development
ADC / BioconjugationMedicinal & Synthetic ChemistryProcess DevelopmentOncologyAntibody-Drug Conjugate (ADC)Bispecific / Multispecific Antibody
WuXi XDC
Unclaimed · public records
CDMO · ADC / Bioconjugation, Drug Substance: Biologics, Drug Substance: Small Molecule / API
ADC / BioconjugationDrug Substance: BiologicsDrug Substance: Small Molecule / APIOncologyHematologyAntibody-Drug Conjugate (ADC)Monoclonal Antibody (mAb)
WuXi STA (STA Pharmaceutical)
Unclaimed · public records
CDMO · Peptide / Oligo Synthesis, Drug Substance: Small Molecule / API, ADC / Bioconjugation
Peptide / Oligo SynthesisDrug Substance: Small Molecule / APIADC / BioconjugationOncologyMetabolic / EndocrinologyOligonucleotide (ASO / siRNA)Peptide
CPC Scientific
Unclaimed · public records
CDMO · Peptide / Oligo Synthesis, Process Development, Analytical Development
Peptide / Oligo SynthesisProcess DevelopmentAnalytical DevelopmentMetabolic / EndocrinologyOncologyPeptideOligonucleotide (ASO / siRNA)
Phosphorex
Unclaimed · public records
CDMO · LNP / Delivery Formulation, Formulation Development, Process Development
LNP / Delivery FormulationFormulation DevelopmentProcess DevelopmentOncologyRare / Orphan DiseasemRNA / saRNAOligonucleotide (ASO / siRNA)
Ascendia Pharmaceutical Solutions
Unclaimed · public records
CDMO · LNP / Delivery Formulation, Formulation Development, Drug Product Manufacturing
LNP / Delivery FormulationFormulation DevelopmentDrug Product ManufacturingOncologyCNS / NeurologymRNA / saRNASmall Molecule
Acuitas Therapeutics
Unclaimed · public records
CDMO · LNP / Delivery Formulation, Formulation Development, Process Development
LNP / Delivery FormulationFormulation DevelopmentProcess DevelopmentInfectious DiseaseRare / Orphan DiseasemRNA / saRNAOligonucleotide (ASO / siRNA)
Genevant Sciences
Unclaimed · public records
CDMO · LNP / Delivery Formulation, Formulation Development, Process Development
LNP / Delivery FormulationFormulation DevelopmentProcess DevelopmentRare / Orphan DiseaseOncologymRNA / saRNAOligonucleotide (ASO / siRNA)
Ajinomoto Bio-Pharma Services
Unclaimed · public records
CRO & CDMO · Peptide / Oligo Synthesis, ADC / Bioconjugation, Drug Substance: Small Molecule / API
Peptide / Oligo SynthesisADC / BioconjugationDrug Substance: Small Molecule / APIOncologyMetabolic / EndocrinologyPeptideOligonucleotide (ASO / siRNA)
Bio-Synthesis Inc
Unclaimed · public records
CDMO · Peptide / Oligo Synthesis, mRNA / RNA Manufacturing, ADC / Bioconjugation
Peptide / Oligo SynthesismRNA / RNA ManufacturingADC / BioconjugationOncologyRare / Orphan DiseaseOligonucleotide (ASO / siRNA)Peptide
TriLink BioTechnologies (Maravai LifeSciences)
Unclaimed · public records
CDMO · mRNA / RNA Manufacturing, Peptide / Oligo Synthesis, Process Development
mRNA / RNA ManufacturingPeptide / Oligo SynthesisProcess DevelopmentOncologyInfectious DiseasemRNA / saRNAOligonucleotide (ASO / siRNA)
Agilent Technologies
Unclaimed · public records
CDMO · Peptide / Oligo Synthesis, Process Development, Analytical Development
Peptide / Oligo SynthesisProcess DevelopmentAnalytical DevelopmentRare / Orphan DiseaseOncologyOligonucleotide (ASO / siRNA)
ST Pharm
Unclaimed · public records
CDMO · Peptide / Oligo Synthesis, mRNA / RNA Manufacturing, Process Development
Peptide / Oligo SynthesismRNA / RNA ManufacturingProcess DevelopmentRare / Orphan DiseaseOncologyOligonucleotide (ASO / siRNA)mRNA / saRNA
Nitto Avecia Pharma Services
Unclaimed · public records
CDMO · Peptide / Oligo Synthesis, Process Development, Analytical Development
Peptide / Oligo SynthesisProcess DevelopmentAnalytical DevelopmentRare / Orphan DiseaseOncologyOligonucleotide (ASO / siRNA)
WuXi TIDES (WuXi AppTec)
Unclaimed · public records
CRO & CDMO · Peptide / Oligo Synthesis, ADC / Bioconjugation, Medicinal & Synthetic Chemistry
Peptide / Oligo SynthesisADC / BioconjugationMedicinal & Synthetic ChemistryOncologyMetabolic / EndocrinologyPeptideOligonucleotide (ASO / siRNA)
Kaneka Eurogentec
Unclaimed · public records
CDMO · Peptide / Oligo Synthesis, Plasmid DNA Manufacturing, Drug Substance: Biologics
Peptide / Oligo SynthesisPlasmid DNA ManufacturingDrug Substance: BiologicsOncologyInfectious DiseasePeptideOligonucleotide (ASO / siRNA)
PolyPeptide Group
Unclaimed · public records
CDMO · Peptide / Oligo Synthesis, Process Development, Analytical Development
Peptide / Oligo SynthesisProcess DevelopmentAnalytical DevelopmentMetabolic / EndocrinologyOncologyPeptideOligonucleotide (ASO / siRNA)
Advanced BioScience Laboratories (ABL)
Unclaimed · public records
CDMO · Viral Vector Manufacturing, Process Development, Analytical Development
Viral Vector ManufacturingProcess DevelopmentAnalytical DevelopmentOncologyInfectious DiseaseGene Therapy (AAV / Viral Vector)Vaccine
Eurogentec (Kaneka)
Unclaimed · public records
CDMO · Plasmid DNA Manufacturing, Peptide / Oligo Synthesis, mRNA / RNA Manufacturing
Plasmid DNA ManufacturingPeptide / Oligo SynthesismRNA / RNA ManufacturingOncologyRare / Orphan DiseasePlasmid DNAOligonucleotide (ASO / siRNA)
Teva API (TAPI)
Unclaimed · public records
CDMO · Drug Substance: Small Molecule / API, Process Development, Analytical Development
Drug Substance: Small Molecule / APIProcess DevelopmentAnalytical DevelopmentOncologyCNS / NeurologySmall MoleculePeptide
Bachem
Unclaimed · public records
CDMO · Peptide / Oligo Synthesis, Process Development, Analytical Development
Peptide / Oligo SynthesisProcess DevelopmentAnalytical DevelopmentMetabolic / EndocrinologyOncologyPeptideOligonucleotide (ASO / siRNA)
AMPAC Fine Chemicals (SK pharmteco)
Unclaimed · public records
CDMO · Medicinal & Synthetic Chemistry, Process Development, Drug Substance: Small Molecule / API
Medicinal & Synthetic ChemistryProcess DevelopmentDrug Substance: Small Molecule / APIOncologyCNS / NeurologySmall MoleculeOligonucleotide (ASO / siRNA)
Veranova
Unclaimed · public records
CDMO · Medicinal & Synthetic Chemistry, Process Development, Drug Substance: Small Molecule / API
Medicinal & Synthetic ChemistryProcess DevelopmentDrug Substance: Small Molecule / APIOncologyCNS / NeurologySmall MoleculePeptide
EUROAPI
Unclaimed · public records
CDMO · Drug Substance: Small Molecule / API, Process Development, Analytical Development
Drug Substance: Small Molecule / APIProcess DevelopmentAnalytical DevelopmentOncologyCardiovascularSmall MoleculePeptide
CordenPharma
Unclaimed · public records
CRO & CDMO · Drug Substance: Small Molecule / API, Process Development, Analytical Development
Drug Substance: Small Molecule / APIProcess DevelopmentAnalytical DevelopmentOncologyMetabolic / EndocrinologySmall MoleculePeptide
WuXi STA (WuXi AppTec)
Unclaimed · public records
CRO & CDMO · Medicinal & Synthetic Chemistry, Process Development, Analytical Development
Medicinal & Synthetic ChemistryProcess DevelopmentAnalytical DevelopmentOncologyHematologySmall MoleculePeptide
Asymchem
Unclaimed · public records
CRO & CDMO · Medicinal & Synthetic Chemistry, Process Development, Drug Substance: Small Molecule / API
Medicinal & Synthetic ChemistryProcess DevelopmentDrug Substance: Small Molecule / APIOncologyMetabolic / EndocrinologySmall MoleculePeptide
Eurofins (Pharma Discovery & Bioanalytical Services)
Unclaimed · public records
CRO & CDMO · Bioanalytical Services, Central Laboratory Services, Genetic Toxicology
Bioanalytical ServicesCentral Laboratory ServicesGenetic ToxicologyOncologyCNS / NeurologySmall MoleculeMonoclonal Antibody (mAb)
QPS Holdings
Unclaimed · public records
CRO · Bioanalytical Services, DMPK / ADME, GLP Toxicology
Bioanalytical ServicesDMPK / ADMEGLP ToxicologyCNS / NeurologyOncologySmall MoleculeMonoclonal Antibody (mAb)
NorthEast BioLab
Unclaimed · public records
CRO · Bioanalytical Services, Immunogenicity & Immunotoxicology, Biomarker Discovery & Development
Bioanalytical ServicesImmunogenicity & ImmunotoxicologyBiomarker Discovery & DevelopmentOncologyImmunology & InflammationSmall MoleculeMonoclonal Antibody (mAb)
Synexa Life Sciences
Unclaimed · public records
CRO · Biomarker Discovery & Development, Bioanalytical Services, Immunogenicity & Immunotoxicology
Biomarker Discovery & DevelopmentBioanalytical ServicesImmunogenicity & ImmunotoxicologyOncologyImmunology & InflammationMonoclonal Antibody (mAb)Protein / Enzyme (Recombinant)
Simulations Plus
Unclaimed · public records
CRO · PK/PD & Modeling, DMPK / ADME, In Vitro / Early Toxicology
PK/PD & ModelingDMPK / ADMEIn Vitro / Early ToxicologyOncologyCNS / NeurologySmall MoleculePeptide
Certara
Unclaimed · public records
CRO · PK/PD & Modeling, Biostatistics & Statistical Programming, Medical Writing
PK/PD & ModelingBiostatistics & Statistical ProgrammingMedical WritingOncologyCNS / NeurologySmall MoleculeMonoclonal Antibody (mAb)
Labcorp
Unclaimed · public records
CRO & CDMO · Central Laboratory Services, GLP Toxicology, Safety Pharmacology
Central Laboratory ServicesGLP ToxicologySafety PharmacologyOncologyCNS / NeurologySmall MoleculeMonoclonal Antibody (mAb)
Q2 Solutions
Unclaimed · public records
CRO · Central Laboratory Services, Biomarker Discovery & Development, Bioanalytical Services
Central Laboratory ServicesBiomarker Discovery & DevelopmentBioanalytical ServicesOncologyImmunology & InflammationSmall MoleculeMonoclonal Antibody (mAb)
BioAgilytix Labs
Unclaimed · public records
CRO · Bioanalytical Services, Immunogenicity & Immunotoxicology, Biomarker Discovery & Development
Bioanalytical ServicesImmunogenicity & ImmunotoxicologyBiomarker Discovery & DevelopmentOncologyImmunology & InflammationMonoclonal Antibody (mAb)Protein / Enzyme (Recombinant)
Twist Bioscience
Unclaimed · public records
CRO · Target ID & Validation, Assay Development & Screening, Hit-to-Lead
Target ID & ValidationAssay Development & ScreeningHit-to-LeadOncologyImmunology & InflammationMonoclonal Antibody (mAb)Bispecific / Multispecific Antibody
Abzena
Unclaimed · public records
CRO & CDMO · Assay Development & Screening, Hit-to-Lead, Lead Optimization
Assay Development & ScreeningHit-to-LeadLead OptimizationOncologyImmunology & InflammationMonoclonal Antibody (mAb)Bispecific / Multispecific Antibody
Sygnature Discovery
Unclaimed · public records
CRO · Target ID & Validation, Assay Development & Screening, Hit-to-Lead
Target ID & ValidationAssay Development & ScreeningHit-to-LeadOncologyCNS / NeurologySmall MoleculePeptide
Syngene International
Unclaimed · public records
CRO & CDMO · GLP Toxicology, Safety Pharmacology, DMPK / ADME
GLP ToxicologySafety PharmacologyDMPK / ADMEOncologyCNS / NeurologySmall MoleculeMonoclonal Antibody (mAb)
Sai Life Sciences
Unclaimed · public records
CRO & CDMO · DMPK / ADME, In Vitro / Early Toxicology, GLP Toxicology
DMPK / ADMEIn Vitro / Early ToxicologyGLP ToxicologyOncologyCNS / NeurologySmall MoleculePeptide
KCAS Bio
Unclaimed · public records
CRO · Bioanalytical Services, Biomarker Discovery & Development, Immunogenicity & Immunotoxicology
Bioanalytical ServicesBiomarker Discovery & DevelopmentImmunogenicity & ImmunotoxicologyOncologyCardiovascularSmall MoleculeMonoclonal Antibody (mAb)
IQVIA Laboratories (Q2 Solutions)
Unclaimed · public records
CRO · Bioanalytical Services, Biomarker Discovery & Development, DMPK / ADME
Bioanalytical ServicesBiomarker Discovery & DevelopmentDMPK / ADMEOncologyImmunology & InflammationSmall MoleculeMonoclonal Antibody (mAb)
Nuvisan
Unclaimed · public records
CRO & CDMO · DMPK / ADME, Bioanalytical Services, In Vitro / Early Toxicology
DMPK / ADMEBioanalytical ServicesIn Vitro / Early ToxicologyOncologyCNS / NeurologySmall MoleculePeptide
Biotrial
Unclaimed · public records
CRO · Safety Pharmacology, GLP Toxicology, Toxicokinetics (TK)
Safety PharmacologyGLP ToxicologyToxicokinetics (TK)CardiovascularCNS / NeurologySmall MoleculeMonoclonal Antibody (mAb)
BioAgilytix
Unclaimed · public records
CRO · Bioanalytical Services, Immunogenicity & Immunotoxicology, Biomarker Discovery & Development
Bioanalytical ServicesImmunogenicity & ImmunotoxicologyBiomarker Discovery & DevelopmentOncologyImmunology & InflammationMonoclonal Antibody (mAb)Bispecific / Multispecific Antibody
Scantox
Unclaimed · public records
CRO · GLP Toxicology, Safety Pharmacology, Genetic Toxicology
GLP ToxicologySafety PharmacologyGenetic ToxicologyOncologyCNS / NeurologySmall MoleculeMonoclonal Antibody (mAb)
Evotec
Unclaimed · public records
CRO & CDMO · In Vitro / Early Toxicology, DMPK / ADME, Safety Pharmacology
In Vitro / Early ToxicologyDMPK / ADMESafety PharmacologyOncologyCNS / NeurologySmall MoleculeMonoclonal Antibody (mAb)
Frontage Laboratories
Unclaimed · public records
CRO & CDMO · GLP Toxicology, Safety Pharmacology, Toxicokinetics (TK)
GLP ToxicologySafety PharmacologyToxicokinetics (TK)OncologyCNS / NeurologySmall MoleculeMonoclonal Antibody (mAb)
WuXi AppTec
Unclaimed · public records
CRO & CDMO · GLP Toxicology, Safety Pharmacology, Genetic Toxicology
GLP ToxicologySafety PharmacologyGenetic ToxicologyOncologyCNS / NeurologySmall MoleculeMonoclonal Antibody (mAb)
Inotiv
Unclaimed · public records
CRO · GLP Toxicology, Safety Pharmacology, Genetic Toxicology
GLP ToxicologySafety PharmacologyGenetic ToxicologyOncologyCNS / NeurologySmall MoleculeMonoclonal Antibody (mAb)
Labcorp (Labcorp Drug Development / former Covance)
Unclaimed · public records
CRO & CDMO · GLP Toxicology, Safety Pharmacology, Genetic Toxicology
GLP ToxicologySafety PharmacologyGenetic ToxicologyOncologyCNS / NeurologySmall MoleculeMonoclonal Antibody (mAb)
Charles River Laboratories
Unclaimed · public records
CRO & CDMO · GLP Toxicology, Safety Pharmacology, Genetic Toxicology
GLP ToxicologySafety PharmacologyGenetic ToxicologyOncologyCNS / NeurologySmall MoleculeMonoclonal Antibody (mAb)
Precision for Medicine
Unclaimed · public records
CRO · Clinical Operations, Clinical Data Management, Biostatistics & Statistical Programming
Clinical OperationsClinical Data ManagementBiostatistics & Statistical ProgrammingOncologyHematologySmall MoleculeMonoclonal Antibody (mAb)
Pharmaron
Unclaimed · public records
CRO & CDMO · Clinical Operations, Clinical Data Management, Biostatistics & Statistical Programming
Clinical OperationsClinical Data ManagementBiostatistics & Statistical ProgrammingOncologyCNS / NeurologySmall MoleculeMonoclonal Antibody (mAb)
CMIC Group
Unclaimed · public records
CRO & CDMO · Clinical Operations, Clinical Data Management, Biostatistics & Statistical Programming
Clinical OperationsClinical Data ManagementBiostatistics & Statistical ProgrammingOncologyCNS / NeurologySmall MoleculeMonoclonal Antibody (mAb)
Altasciences
Unclaimed · public records
CRO & CDMO · Phase 1 / Early Clinical Unit, Clinical Operations, Bioanalytical Services
Phase 1 / Early Clinical UnitClinical OperationsBioanalytical ServicesOncologyCNS / NeurologySmall MoleculeMonoclonal Antibody (mAb)
Celerion
Unclaimed · public records
CRO · Phase 1 / Early Clinical Unit, Clinical Operations, Bioanalytical Services
Phase 1 / Early Clinical UnitClinical OperationsBioanalytical ServicesOncologyCNS / NeurologySmall MoleculeMonoclonal Antibody (mAb)
Novotech
Unclaimed · public records
CRO · Clinical Operations, Clinical Data Management, Biostatistics & Statistical Programming
Clinical OperationsClinical Data ManagementBiostatistics & Statistical ProgrammingOncologyHematologySmall MoleculeMonoclonal Antibody (mAb)
Veristat
Unclaimed · public records
CRO · Clinical Operations, Clinical Data Management, Biostatistics & Statistical Programming
Clinical OperationsClinical Data ManagementBiostatistics & Statistical ProgrammingOncologyHematologySmall MoleculeMonoclonal Antibody (mAb)
Allucent
Unclaimed · public records
CRO · Clinical Operations, Clinical Data Management, Biostatistics & Statistical Programming
Clinical OperationsClinical Data ManagementBiostatistics & Statistical ProgrammingOncologyHematologySmall MoleculeMonoclonal Antibody (mAb)
Worldwide Clinical Trials
Unclaimed · public records
CRO · Clinical Operations, Phase 1 / Early Clinical Unit, Clinical Data Management
Clinical OperationsPhase 1 / Early Clinical UnitClinical Data ManagementOncologyHematologySmall MoleculeMonoclonal Antibody (mAb)
Syneos Health
Unclaimed · public records
CRO · Clinical Operations, Phase 1 / Early Clinical Unit, Clinical Data Management
Clinical OperationsPhase 1 / Early Clinical UnitClinical Data ManagementOncologyHematologySmall MoleculeMonoclonal Antibody (mAb)
Medpace
Unclaimed · public records
CRO · Clinical Operations, Phase 1 / Early Clinical Unit, Clinical Data Management
Clinical OperationsPhase 1 / Early Clinical UnitClinical Data ManagementOncologyHematologySmall MoleculeMonoclonal Antibody (mAb)
Fortrea
Unclaimed · public records
CRO · Clinical Operations, Phase 1 / Early Clinical Unit, Clinical Data Management
Clinical OperationsPhase 1 / Early Clinical UnitClinical Data ManagementOncologyHematologySmall MoleculeMonoclonal Antibody (mAb)
PPD (Thermo Fisher Scientific)
Unclaimed · public records
CRO · Clinical Operations, Phase 1 / Early Clinical Unit, Clinical Data Management
Clinical OperationsPhase 1 / Early Clinical UnitClinical Data ManagementOncologyHematologySmall MoleculeMonoclonal Antibody (mAb)
Parexel
Unclaimed · public records
CRO · Clinical Operations, Phase 1 / Early Clinical Unit, Clinical Data Management
Clinical OperationsPhase 1 / Early Clinical UnitClinical Data ManagementOncologyHematologySmall MoleculeMonoclonal Antibody (mAb)
ICON plc
Unclaimed · public records
CRO · Clinical Operations, Phase 1 / Early Clinical Unit, Clinical Data Management
Clinical OperationsPhase 1 / Early Clinical UnitClinical Data ManagementOncologyHematologySmall MoleculeMonoclonal Antibody (mAb)
IQVIA
Unclaimed · public records
CRO · Clinical Operations, Clinical Data Management, Biostatistics & Statistical Programming
Clinical OperationsClinical Data ManagementBiostatistics & Statistical ProgrammingOncologyHematologySmall MoleculeMonoclonal Antibody (mAb)
What does it take to develop and manufacture a Oligonucleotide (ASO / siRNA) drug?
Oligonucleotides look deceptively simple on paper, a short string of nucleotides, but the chemistry that makes them work as drugs is where the difficulty lives. An antisense oligo (ASO) and a small interfering RNA (siRNA) are made the same way at the bench, by solid-phase phosphoramidite synthesis, yet almost everything else differs: ASOs are single strands that recruit RNase H or block splicing, siRNAs are duplexes that load into RISC. Both depend on backbone and sugar modifications (phosphorothioate linkages, 2'-MOE, 2'-O-methyl, 2'-fluoro, LNA, and the morpholino variant) to survive nucleases and stay in the body long enough to act. Get the modification pattern wrong and you have a sequence that is potent in a dish and useless in an animal.
On the discovery and preclinical side, the work that gets outsourced is sequence design and screening, chemical modification scans, in vitro potency and knockdown assays, off-target and hybridization-dependent toxicity screening, and the delivery decision. Delivery is the whole game for this modality. GalNAc conjugation gets siRNA and some ASOs into hepatocytes cleanly, which is why so many approved oligos are liver-targeted; everything outside the liver (CNS via intrathecal dosing, muscle, tumor) is harder and often leans on lipid nanoparticles or newer conjugates. A CRO that understands which delivery approach fits your target tissue saves you a year of dead ends.
On the CMC and manufacturing side, this is where specialist oligo CDMOs separate themselves from generalists. Solid-phase oligo synthesis at scale is its own discipline: it needs the right synthesizer column chemistry, controlled-pore-glass or polystyrene supports, amidite supply and quality, and a real handle on process-related impurities (n-1 and n+1 shortmers, depurination products, P=O versus P=S diastereomers). The analytical burden is heavier than most small molecules: identity and purity by ion-pair reversed-phase LC-MS, anion-exchange HPLC, capillary gel electrophoresis, and impurity characterization down the chain. A generalist API shop can run an HPLC, but it usually does not have validated oligo-specific methods, the purification trains (large-scale ion-exchange and reversed-phase), or the regulatory history of filing oligo CMC sections. For GalNAc or LNP work you also need conjugation and formulation capability under GMP, which narrows the field further.
How do you choose a CRO or CDMO for Oligonucleotide (ASO / siRNA)?
The fastest way to waste budget on this modality is to hire a competent generalist who has never actually shipped an oligo. Use a checklist built around the things that are specific to ASO and siRNA work, and ask for evidence on each, not assurances.
- Relevant platform and track record: confirmed solid-phase synthesis experience with your chemistry (phosphorothioate, 2'-MOE/2'-OMe/2'-F, LNA, or morpholino), and named programs they have actually delivered, ideally with at least one that reached the clinic. Ask which modality they do most, ASO single strands or siRNA duplexes, because annealing and duplex QC are a separate skill.
- Delivery and conjugation fit: real GalNAc conjugation capability if you are targeting liver, or LNP / lipid-conjugate formulation if you are going elsewhere. Match this to your target tissue before anything else.
- GxP and analytical capability for this modality: validated oligo-specific methods (ion-pair LC-MS, anion-exchange HPLC, CGE), impurity profiling for shortmers and process-related species, and GMP status appropriate to your stage (non-GLP for discovery screens, GLP for the tox package, GMP for clinical supply).
- Capacity and scale: can they take you from milligram research batches through GLP tox material to GMP clinical (and eventually commercial) supply without a disruptive tech transfer? Oligo demand can jump fast once a program reads out; confirm purification train size and suite availability.
- Regulatory experience: have they written oligonucleotide CMC sections that survived FDA or EMA review? Oligo impurity specs and the genotoxicity questions around them are an area where regulator-tested experience genuinely de-risks your filing.
- IP, supply chain, and quality: clear ownership of sequences and process know-how, transparent amidite and starting-material sourcing (single-source amidite risk is real), and a quality system with audit history you can review. Confirm stability-program capability, since oligo stability data drives shelf life.
Frequently asked questions
What is the difference between an ASO and an siRNA, and does it change who I should hire?
Yes, it changes the supplier profile. Both are made by solid-phase phosphoramidite synthesis, so a synthesis CRO can usually make either. The difference is downstream. An ASO is a single strand that works through RNase H cleavage or splice modulation, while an siRNA is a duplex of two annealed strands that loads into RISC, which means siRNA work adds an annealing step, duplex purity and stoichiometry QC, and often a sense-strand conjugate. If you are running siRNA, confirm the supplier routinely handles duplex annealing and duplex-specific analytics, not just single-strand synthesis. The modification chemistry and delivery strategy also tend to differ between the two.
Why do oligonucleotide programs need GalNAc conjugation or LNP formulation, and can the same supplier do both synthesis and delivery?
Naked oligos distribute poorly and rarely reach the cells you want. GalNAc conjugation binds the asialoglycoprotein receptor on hepatocytes and delivers siRNA and some ASOs to the liver efficiently, which is why most approved oligos are liver-targeted. For tissues outside the liver you typically need lipid nanoparticles or newer conjugates, plus, for CNS, intrathecal delivery. Some specialist oligo CDMOs do synthesis, conjugation, and GMP formulation under one roof; many do not. If your delivery approach is fixed, make it a gating question early, because a synthesis-only shop will hand off the hardest part to a third party.
What analytical methods should an oligonucleotide CDMO have validated?
At minimum: identity and purity by ion-pair reversed-phase LC-MS, anion-exchange HPLC for charge-related impurities, and capillary gel electrophoresis. They should profile process-related impurities specific to oligos, the n-1 and n+1 shortmers, depurination and longmer species, and (for siRNA) duplex purity and single-strand content. Generalist API CDMOs often lack validated oligo-specific methods and the purification trains that go with them. Ask to see method validation packages and an example certificate of analysis for an oligo, not for a small molecule.
How does manufacturing scale work for oligos, and when does scale become a bottleneck?
Solid-phase synthesis scales by column and synthesizer size, and large-scale ion-exchange and reversed-phase purification trains. Research and early tox material is straightforward; the squeeze usually comes at the GMP clinical stage and again if a program needs commercial tonnage, because amidite supply and purification suite capacity can constrain throughput. The practical move is to pick a partner who can carry you from milligram batches through GMP clinical supply without a disruptive tech transfer mid-program, and to confirm their suite availability and amidite sourcing before you commit, since a single-source amidite is a real supply risk.
Do early oligonucleotide screening studies need to be GLP?
Usually not. Sequence screening, modification scans, in vitro potency and knockdown assays, and exploratory off-target work are research-grade and run under good scientific practice, not GLP. GLP applies to the definitive safety studies that support your IND, which sit in the IND-enabling stage, and GMP applies to material destined for human use. A common and avoidable mistake is paying GMP or GLP prices for exploratory discovery work. Clarify with each supplier whether a given study is exploratory or regulatory-grade before it starts, and scope accordingly.
How does sourcing oligonucleotide CRO and CDMO suppliers through BioBridgeX work?
You describe the program (ASO or siRNA, your chemistry, the delivery approach, target tissue, stage, and the services you need) and you are matched with qualified oligonucleotide CRO and CDMO suppliers who do that specific work. You compare them on relevant track record, analytical and GMP capability, and transparent quotes, then choose. The platform is free for buyers; suppliers pay a flat 2% fee. When a program needs more than one partner, say a synthesis CDMO plus a separate formulation group, you compare quotes and contract directly with each supplier in one place, with BioBridgeX as the neutral marketplace, across all indications and modalities.
Source Oligonucleotide (ASO / siRNA) work with one contract
Compare transparent quotes from qualified Oligonucleotide (ASO / siRNA) CRO and CDMO vendors, then contract once. Free for buyers.
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