UNIQ Trials
PK/PD & ModelingBioanalytical ServicesIND / Regulatory Package AuthoringOncologyHematologySmall MoleculePeptide
Quick answer
Outsourcing gene therapy (AAV or viral vector) means buying specialist help across vector design, preclinical and IND-enabling studies, and the hard part: GMP viral vector and plasmid DNA manufacturing with potency, infectivity, and empty-versus-full capsid analytics. On BioBridgeX, buyers source and compare qualified CROs and CDMOs in one place, free for buyers, with BioBridgeX as the neutral marketplace.
Gene Therapy (AAV / Viral Vector) CRO and CDMO vendors (86)
TRiCBIO
Target ID & ValidationAssay Development & ScreeningHit IdentificationOncologyCNS / NeurologySmall MoleculePeptide
VCHP Clinical Solutions
Computational / AI-Driven DiscoveryPK/PD & ModelingPhase 1 / Early Clinical UnitOncologyHematologySmall MoleculePeptide
Symbiosis Pharmaceutical Services
Unclaimed · public records
CDMO · Aseptic Fill-Finish, Drug Product Manufacturing, QC & Release Testing
Aseptic Fill-FinishDrug Product ManufacturingQC & Release TestingOncologyRare / Orphan DiseaseMonoclonal Antibody (mAb)Antibody-Drug Conjugate (ADC)
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
Merck KGaA (MilliporeSigma / Sigma-Aldrich CTDMO)
Unclaimed · public records
CRO & CDMO · Viral Vector Manufacturing, Cell Therapy Manufacturing, mRNA / RNA Manufacturing
Viral Vector ManufacturingCell Therapy ManufacturingmRNA / RNA ManufacturingOncologyHematologyGene Therapy (AAV / Viral Vector)Cell Therapy (CAR-T / NK / TIL)
Vernal Biosciences
Unclaimed · public records
CDMO · mRNA / RNA Manufacturing, LNP / Delivery Formulation, Plasmid DNA Manufacturing
mRNA / RNA ManufacturingLNP / Delivery FormulationPlasmid DNA ManufacturingOncologyInfectious DiseasemRNA / saRNAPlasmid DNA
Ascend Advanced Therapies
Unclaimed · public records
CDMO · Viral Vector Manufacturing, Process Development, Analytical Development
Viral Vector ManufacturingProcess DevelopmentAnalytical DevelopmentRare / Orphan DiseaseCNS / NeurologyGene Therapy (AAV / Viral Vector)
IDT Biologika
Unclaimed · public records
CDMO · Viral Vector Manufacturing, Process Development, Analytical Development
Viral Vector ManufacturingProcess DevelopmentAnalytical DevelopmentInfectious DiseaseOncologyGene Therapy (AAV / Viral Vector)Vaccine
Vibalogics (ReciBioPharm / Recipharm)
Unclaimed · public records
CDMO · Viral Vector Manufacturing, Process Development, Analytical Development
Viral Vector ManufacturingProcess DevelopmentAnalytical DevelopmentOncologyInfectious DiseaseGene Therapy (AAV / Viral Vector)Vaccine
VectorBuilder
Unclaimed · public records
CRO & CDMO · Viral Vector Manufacturing, Plasmid DNA Manufacturing, Process Development
Viral Vector ManufacturingPlasmid DNA ManufacturingProcess DevelopmentOncologyRare / Orphan DiseaseGene Therapy (AAV / Viral Vector)Plasmid DNA
Pharmaron (Biologics / CGT)
Unclaimed · public records
CRO & CDMO · Viral Vector Manufacturing, Plasmid DNA Manufacturing, Cell Therapy Manufacturing
Viral Vector ManufacturingPlasmid DNA ManufacturingCell Therapy ManufacturingOncologyRare / Orphan DiseaseGene Therapy (AAV / Viral Vector)Plasmid DNA
Esco Aster
Unclaimed · public records
CDMO · Viral Vector Manufacturing, Plasmid DNA Manufacturing, Cell Therapy Manufacturing
Viral Vector ManufacturingPlasmid DNA ManufacturingCell Therapy ManufacturingOncologyInfectious DiseaseGene Therapy (AAV / Viral Vector)Plasmid DNA
3PBIOVIAN (3P Biopharmaceuticals + Biovian)
Unclaimed · public records
CDMO · Viral Vector Manufacturing, Plasmid DNA Manufacturing, Cell Therapy Manufacturing
Viral Vector ManufacturingPlasmid DNA ManufacturingCell Therapy ManufacturingOncologyRare / Orphan DiseaseGene Therapy (AAV / Viral Vector)Plasmid DNA
PackGene Biotech
Unclaimed · public records
CRO & CDMO · Viral Vector Manufacturing, Plasmid DNA Manufacturing, mRNA / RNA Manufacturing
Viral Vector ManufacturingPlasmid DNA ManufacturingmRNA / RNA ManufacturingOncologyRare / Orphan DiseaseGene Therapy (AAV / Viral Vector)mRNA / saRNA
SK pharmteco
Unclaimed · public records
CDMO · Viral Vector Manufacturing, Plasmid DNA Manufacturing, Cell Therapy Manufacturing
Viral Vector ManufacturingPlasmid DNA ManufacturingCell Therapy ManufacturingOncologyHematologyGene Therapy (AAV / Viral Vector)Cell Therapy (CAR-T / NK / TIL)
The Center for Breakthrough Medicines
Unclaimed · public records
CDMO · Viral Vector Manufacturing, Cell Therapy Manufacturing, Plasmid DNA Manufacturing
Viral Vector ManufacturingCell Therapy ManufacturingPlasmid DNA ManufacturingOncologyHematologyGene Therapy (AAV / Viral Vector)Cell Therapy (CAR-T / NK / TIL)
ElevateBio BaseCamp
Unclaimed · public records
CDMO · Cell Therapy Manufacturing, Viral Vector Manufacturing, Process Development
Cell Therapy ManufacturingViral Vector ManufacturingProcess DevelopmentOncologyHematologyCell Therapy (CAR-T / NK / TIL)Gene Therapy (AAV / Viral Vector)
Minaris Advanced Therapies
Unclaimed · public records
CDMO · Cell Therapy Manufacturing, Viral Vector Manufacturing, Process Development
Cell Therapy ManufacturingViral Vector ManufacturingProcess DevelopmentOncologyHematologyCell Therapy (CAR-T / NK / TIL)Gene Therapy (AAV / Viral Vector)
Genezen
Unclaimed · public records
CDMO · Viral Vector Manufacturing, Cell Therapy Manufacturing, Plasmid DNA Manufacturing
Viral Vector ManufacturingCell Therapy ManufacturingPlasmid DNA ManufacturingOncologyHematologyGene Therapy (AAV / Viral Vector)Cell Therapy (CAR-T / NK / TIL)
Viralgen (AskBio)
Unclaimed · public records
CDMO · Viral Vector Manufacturing, Process Development, Analytical Development
Viral Vector ManufacturingProcess DevelopmentAnalytical DevelopmentRare / Orphan DiseaseCNS / NeurologyGene Therapy (AAV / Viral Vector)
Andelyn Biosciences
Unclaimed · public records
CDMO · Viral Vector Manufacturing, Plasmid DNA Manufacturing, Process Development
Viral Vector ManufacturingPlasmid DNA ManufacturingProcess DevelopmentRare / Orphan DiseaseCNS / NeurologyGene Therapy (AAV / Viral Vector)Plasmid DNA
Forge Biologics (Ajinomoto)
Unclaimed · public records
CDMO · Viral Vector Manufacturing, Plasmid DNA Manufacturing, Process Development
Viral Vector ManufacturingPlasmid DNA ManufacturingProcess DevelopmentRare / Orphan DiseaseCNS / NeurologyGene Therapy (AAV / Viral Vector)Plasmid DNA
National Resilience
Unclaimed · public records
CDMO · Viral Vector Manufacturing, Cell Therapy Manufacturing, mRNA / RNA Manufacturing
Viral Vector ManufacturingCell Therapy ManufacturingmRNA / RNA ManufacturingOncologyHematologyGene Therapy (AAV / Viral Vector)Cell Therapy (CAR-T / NK / TIL)
FUJIFILM Biotechnologies (formerly FUJIFILM Diosynth)
Unclaimed · public records
CDMO · Viral Vector Manufacturing, Cell Therapy Manufacturing, Process Development
Viral Vector ManufacturingCell Therapy ManufacturingProcess DevelopmentOncologyRare / Orphan DiseaseGene Therapy (AAV / Viral Vector)Cell Therapy (CAR-T / NK / TIL)
Oxford Biomedica
Unclaimed · public records
CDMO · Viral Vector Manufacturing, Plasmid DNA Manufacturing, Process Development
Viral Vector ManufacturingPlasmid DNA ManufacturingProcess DevelopmentOncologyHematologyGene Therapy (AAV / Viral Vector)Cell Therapy (CAR-T / NK / TIL)
WuXi Advanced Therapies
Unclaimed · public records
CRO & CDMO · Viral Vector Manufacturing, Cell Therapy Manufacturing, Plasmid DNA Manufacturing
Viral Vector ManufacturingCell Therapy ManufacturingPlasmid DNA ManufacturingOncologyHematologyGene Therapy (AAV / Viral Vector)Cell Therapy (CAR-T / NK / TIL)
Catalent
Unclaimed · public records
CDMO · Viral Vector Manufacturing, Cell Therapy Manufacturing, Plasmid DNA Manufacturing
Viral Vector ManufacturingCell Therapy ManufacturingPlasmid DNA ManufacturingOncologyHematologyGene Therapy (AAV / Viral Vector)Cell Therapy (CAR-T / NK / TIL)
GenScript ProBio
Unclaimed · public records
CDMO · Cell Line / Strain Development, Process Development, Analytical Development
Cell Line / Strain DevelopmentProcess DevelopmentAnalytical DevelopmentOncologyImmunology & InflammationMonoclonal Antibody (mAb)Bispecific / Multispecific Antibody
3PBIOVIAN
Unclaimed · public records
CDMO · Cell Line / Strain Development, Process Development, Analytical Development
Cell Line / Strain DevelopmentProcess DevelopmentAnalytical DevelopmentOncologyImmunology & InflammationMonoclonal Antibody (mAb)Protein / Enzyme (Recombinant)
ProBioGen
Unclaimed · public records
CDMO · Cell Line / Strain Development, Process Development, Analytical Development
Cell Line / Strain DevelopmentProcess DevelopmentAnalytical DevelopmentOncologyImmunology & InflammationMonoclonal Antibody (mAb)Bispecific / Multispecific Antibody
Northway Biotech
Unclaimed · public records
CDMO · Cell Line / Strain Development, Process Development, Analytical Development
Cell Line / Strain DevelopmentProcess DevelopmentAnalytical DevelopmentOncologyImmunology & InflammationMonoclonal Antibody (mAb)Protein / Enzyme (Recombinant)
AGC Biologics
Unclaimed · public records
CDMO · Cell Line / Strain Development, Process Development, Analytical Development
Cell Line / Strain DevelopmentProcess DevelopmentAnalytical DevelopmentOncologyImmunology & InflammationMonoclonal Antibody (mAb)Bispecific / Multispecific Antibody
FUJIFILM Diosynth Biotechnologies
Unclaimed · public records
CDMO · Cell Line / Strain Development, Process Development, Analytical Development
Cell Line / Strain DevelopmentProcess DevelopmentAnalytical DevelopmentOncologyImmunology & InflammationMonoclonal Antibody (mAb)Bispecific / Multispecific Antibody
Catalent Biologics
Unclaimed · public records
CDMO · Cell Line / Strain Development, Process Development, Analytical Development
Cell Line / Strain DevelopmentProcess DevelopmentAnalytical DevelopmentOncologyImmunology & InflammationMonoclonal Antibody (mAb)Bispecific / Multispecific Antibody
Thermo Fisher Scientific (Patheon)
Unclaimed · public records
CRO & CDMO · Process Development, Drug Substance: Small Molecule / API, Analytical Development
Process DevelopmentDrug Substance: Small Molecule / APIAnalytical DevelopmentOncologyCNS / NeurologySmall MoleculeMonoclonal Antibody (mAb)
Lonza
Unclaimed · public records
CRO & CDMO · Drug Substance: Small Molecule / API, Process Development, Analytical Development
Drug Substance: Small Molecule / APIProcess DevelopmentAnalytical DevelopmentOncologyRare / Orphan DiseaseSmall MoleculeAntibody-Drug Conjugate (ADC)
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)
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)
CellCarta
Unclaimed · public records
CRO · Biomarker Discovery & Development, Bioanalytical Services, Immunogenicity & Immunotoxicology
Biomarker Discovery & DevelopmentBioanalytical ServicesImmunogenicity & ImmunotoxicologyOncologyImmunology & InflammationMonoclonal Antibody (mAb)Protein / Enzyme (Recombinant)
Certara
Unclaimed · public records
CRO · PK/PD & Modeling, Biostatistics & Statistical Programming, Medical Writing
PK/PD & ModelingBiostatistics & Statistical ProgrammingMedical WritingOncologyCNS / NeurologySmall MoleculeMonoclonal Antibody (mAb)
LabConnect
Unclaimed · public records
CRO · Central Laboratory Services, Biomarker Discovery & Development, Clinical Data Management
Central Laboratory ServicesBiomarker Discovery & DevelopmentClinical Data ManagementOncologyImmunology & InflammationSmall 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)
GemPharmatech
Unclaimed · public records
CRO · In Vitro Pharmacology, Target ID & Validation, Biomarker Discovery & Development
In Vitro PharmacologyTarget ID & ValidationBiomarker Discovery & DevelopmentOncologyMetabolic / EndocrinologySmall MoleculeMonoclonal Antibody (mAb)
Labcorp (Labcorp Drug Development)
Unclaimed · public records
CRO · In Vitro Pharmacology, DMPK / ADME, GLP Toxicology
In Vitro PharmacologyDMPK / ADMEGLP ToxicologyOncologyCNS / NeurologySmall MoleculeMonoclonal Antibody (mAb)
The Jackson Laboratory (JAX)
Unclaimed · public records
CRO · In Vitro Pharmacology, Biomarker Discovery & Development, Target ID & Validation
In Vitro PharmacologyBiomarker Discovery & DevelopmentTarget ID & ValidationOncologyHematologySmall MoleculeMonoclonal Antibody (mAb)
JOINN Laboratories / Biomere
Unclaimed · public records
CRO · GLP Toxicology, Safety Pharmacology, Toxicokinetics (TK)
GLP ToxicologySafety PharmacologyToxicokinetics (TK)OncologyCNS / NeurologySmall MoleculeMonoclonal Antibody (mAb)
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)
Lovelace Biomedical
Unclaimed · public records
CRO · GLP Toxicology, Safety Pharmacology, Toxicokinetics (TK)
GLP ToxicologySafety PharmacologyToxicokinetics (TK)RespiratoryInfectious DiseaseSmall MoleculeMonoclonal Antibody (mAb)
Vivotecnia
Unclaimed · public records
CRO · GLP Toxicology, Safety Pharmacology, Genetic Toxicology
GLP ToxicologySafety PharmacologyGenetic ToxicologyOncologyCNS / 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
Crown Bioscience
Unclaimed · public records
CRO · In Vitro Pharmacology, Biomarker Discovery & Development, Assay Development & Screening
In Vitro PharmacologyBiomarker Discovery & DevelopmentAssay Development & ScreeningOncologyHematologySmall 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)
Avance Clinical
Unclaimed · public records
CRO · Clinical Operations, Phase 1 / Early Clinical Unit, Clinical Data Management
Clinical OperationsPhase 1 / Early Clinical UnitClinical Data ManagementOncologyCNS / NeurologySmall MoleculeMonoclonal Antibody (mAb)
TFS HealthScience
Unclaimed · public records
CRO · Clinical Operations, Clinical Data Management, Biostatistics & Statistical Programming
Clinical OperationsClinical Data ManagementBiostatistics & Statistical ProgrammingOncologyHematologySmall MoleculeMonoclonal Antibody (mAb)
Cytel
Unclaimed · public records
CRO · Biostatistics & Statistical Programming, Clinical Data Management, Clinical Operations
Biostatistics & Statistical ProgrammingClinical Data ManagementClinical OperationsOncologyHematologySmall 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)
WuXi Clinical
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)
Tigermed
Unclaimed · public records
CRO · Clinical Operations, Clinical Data Management, Biostatistics & Statistical Programming
Clinical OperationsClinical Data ManagementBiostatistics & Statistical ProgrammingOncologyHematologySmall 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)
Linical
Unclaimed · public records
CRO · Clinical Operations, Clinical Data Management, Biostatistics & Statistical Programming
Clinical OperationsClinical Data ManagementBiostatistics & Statistical ProgrammingOncologyCNS / NeurologySmall MoleculeMonoclonal Antibody (mAb)
ClinChoice
Unclaimed · public records
CRO · Clinical Operations, Clinical Data Management, Biostatistics & Statistical Programming
Clinical OperationsClinical Data ManagementBiostatistics & Statistical ProgrammingOncologyCNS / NeurologySmall MoleculeMonoclonal Antibody (mAb)
Emmes
Unclaimed · public records
CRO · Clinical Operations, Clinical Data Management, Biostatistics & Statistical Programming
Clinical OperationsClinical Data ManagementBiostatistics & Statistical ProgrammingOncologyHematologySmall MoleculeMonoclonal Antibody (mAb)
ProPharma
Unclaimed · public records
CRO · Clinical Operations, Clinical Data Management, Biostatistics & Statistical Programming
Clinical OperationsClinical Data ManagementBiostatistics & Statistical ProgrammingOncologyCNS / 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)
Premier Research
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)
Caidya
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)
PSI CRO
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 Gene Therapy (AAV / Viral Vector) drug?
Gene therapy stretches a development team across two very different worlds. The early science looks like any biologics program: pick a transgene, choose or engineer a capsid serotype that reaches the target tissue, design the expression cassette and promoter, then prove in preclinical models that the construct does what you claim without lighting up the immune system. The hard, expensive reality lands later, in CMC. The vector you make is not a small molecule with a clean structure; it is a population of viral particles, some full of your genome and some empty, and your process and your analytics define the product as much as the sequence does. That is why so many gene therapy programs that read well on biology stall at manufacturing.
A typical program needs a CRO for the discovery and preclinical work (capsid screening, biodistribution and shedding studies, immunogenicity and GLP toxicology in a relevant species), then a CDMO for process development and GMP supply. The manufacturing side is where the specialist gap is widest. Upstream, you are running either a transient transfection process (three or four plasmids into HEK293 cells, which means you also need GMP plasmid DNA) or a producer or packaging cell line. Downstream, you are clarifying, concentrating, and polishing with affinity chromatography and tangential flow filtration, then trying to separate full capsids from empty ones, often by anion exchange or gradient ultracentrifugation. Each step bleeds yield, and AAV yields are low to begin with, so process choices made early ripple straight into cost of goods and how many patients a batch can dose.
The analytics are the part generalists underestimate. You need vector genome titer (qPCR or ddPCR), capsid titer, the full-to-empty ratio, infectivity and potency assays that tie back to mechanism, residual host cell DNA and protein, residual plasmid and helper, replication-competent virus testing, and aggregation. A CDMO that has built and qualified these assays for AAV, and ideally has a platform process across serotypes, is in a different category from a contract biologics shop that lists gene therapy on a capabilities page. Specialist viral vector CDMOs differ from generalists in three concrete ways: a real platform process they can adapt rather than invent from scratch, a qualified AAV-specific analytical panel, and people who have actually carried a vector through a regulatory filing and the FDA potency and comparability questions that come with it.
Frequently asked questions
What is the difference between a gene therapy CRO and a viral vector CDMO?
They cover different halves of the program. A CRO runs the research and preclinical work: capsid and serotype screening, transgene and cassette design, biodistribution and shedding studies, immunogenicity, and GLP toxicology that supports your IND. A CDMO makes the actual drug, which for AAV means process development plus GMP manufacturing of the viral vector and usually the plasmid DNA that feeds it, along with the analytics that release each batch. Some larger organizations do both, but the manufacturing and analytical depth is where you should scrutinize hardest, because that is where gene therapy programs stall. On BioBridgeX you can source both sides and contract directly with each chosen supplier in one place.
How much does AAV gene therapy manufacturing cost and how long does it take?
It is expensive and slow relative to most modalities, and any single number is misleading because it swings with serotype, scale, and yield. The honest framing: GMP plasmid DNA and AAV process development plus a GMP campaign typically run many months to over a year before you have releasable material, and plasmid lead times alone can be a meaningful chunk of that. Cost is driven by low AAV yields, the number of plasmids in a transfection process, and the long analytical release panel. The practical levers are choosing a CDMO with a platform process rather than a bespoke one, locking plasmid supply early, and scoping process development, engineering runs, and GMP lots as separate milestones with go/no-go gates.
Why does the full-to-empty capsid ratio matter when choosing a CDMO?
Empty capsids carry no transgene but still trigger an immune response and dilute your effective dose, so regulators and clinicians care about the ratio, and your CDMO's ability to measure and control it is a core competence, not a nicety. Separating full from empty capsids is one of the hardest downstream steps, usually done by anion exchange chromatography or gradient ultracentrifugation, and each approach trades purity against yield. When you evaluate a CDMO, ask how they measure the full-to-empty ratio (analytical ultracentrifugation, charge-detection mass spec, ddPCR-to-ELISA ratio), what ratio they routinely achieve at your serotype, and how they control it at scale. A supplier that is vague here has not solved the problem.
Should I use a transient transfection process or a stable producer cell line?
Most AAV today is made by transient transfection, where three or four plasmids go into HEK293 cells. It is flexible and fast to start, which suits early programs, but it consumes large amounts of GMP plasmid and gets expensive and harder to control as you scale. Stable producer or packaging cell lines remove the plasmid burden and can improve consistency and cost at commercial scale, but they take time and money to build and lock you into a serotype and construct. The right answer depends on where you are: transient is often pragmatic through early clinical, while a stable line becomes attractive if you are heading toward a large indication. Ask each CDMO which they run, and whether they can carry you from one to the other without a full comparability restart.
Do I need a CDMO with prior FDA or EMA gene therapy filing experience?
Yes, and it is one of the most undervalued selection criteria. Gene therapy CMC draws specific agency scrutiny: potency assays that genuinely reflect mechanism, comparability when you change process or scale, replication-competent virus testing, and control of empty capsids and residual impurities. A CDMO that has carried a vector through an IND, and ideally a BLA, has already answered these questions and built the documentation and assays to support them. One that has only made research-grade material will be learning on your program, on your timeline and budget. Ask directly how many client vectors have reached IND or approval, and whether their potency and comparability strategy has survived real agency review.
Can BioBridgeX handle a program that needs both a preclinical CRO and a viral vector CDMO?
Yes, that is a core reason buyers use it. You can source the preclinical CRO and the viral vector CDMO (and the GMP plasmid DNA supplier, if separate) through the same platform, comparing quotes and contracting directly with each chosen supplier in one place, with BioBridgeX as the neutral marketplace across all of them. It is free for buyers, with a flat 2% fee charged to suppliers, and it spans all indications and modalities, so a gene therapy program that also needs, say, analytical method development or fill-finish does not splinter into a dozen separate contracts. You start the sourcing yourself and compare qualified suppliers before committing.
Source Gene Therapy (AAV / Viral Vector) work with one contract
Compare transparent quotes from qualified Gene Therapy (AAV / Viral Vector) CRO and CDMO vendors, then contract once. Free for buyers.
Compare quotes