Altheome
Assay Development & ScreeningProtein Sciences & ReagentsPK/PD & ModelingOncologyHematologySmall MoleculePeptide
Quick answer
Analytical development is the CMC work that builds and qualifies the test methods proving your drug's identity, purity, potency, and impurities. You need it the moment material moves toward GMP and the clinic, since you cannot release a batch you cannot measure. On BioBridgeX, buyers source and compare qualified CDMOs for this exact work in one place.
Analytical Development CDMOs (147)
Apeloa Pharmaceutical
Target ID & ValidationAssay Development & ScreeningHit IdentificationOncologyHematologySmall MoleculePeptide
AAPharmaSyn
Hit IdentificationHit-to-LeadLead OptimizationOncologyHematologySmall MoleculeRadiopharmaceutical / Radioligand
Famar Group
Unclaimed · public records
CDMO · Formulation Development, LNP / Delivery Formulation, Process Development
Formulation DevelopmentLNP / Delivery FormulationProcess DevelopmentMetabolic / EndocrinologyCardiovascularSmall MoleculeProtein / Enzyme (Recombinant)
Singota Solutions
Unclaimed · public records
CDMO · Aseptic Fill-Finish, Drug Product Manufacturing, QC & Release Testing
Aseptic Fill-FinishDrug Product ManufacturingQC & Release TestingOncologyImmunology & InflammationSmall MoleculeMonoclonal Antibody (mAb)
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)
Lifecore Biomedical
Unclaimed · public records
CDMO · Formulation Development, LNP / Delivery Formulation, Process Development
Formulation DevelopmentLNP / Delivery FormulationProcess DevelopmentOphthalmologyOncologySmall MoleculeProtein / Enzyme (Recombinant)
Grand River Aseptic Manufacturing (GRAM)
Unclaimed · public records
CDMO · Formulation Development, LNP / Delivery Formulation, Process Development
Formulation DevelopmentLNP / Delivery FormulationProcess DevelopmentOncologyInfectious DiseaseSmall MoleculeMonoclonal Antibody (mAb)
Curia Global
Unclaimed · public records
CRO & CDMO · Drug Substance: Small Molecule / API, Drug Substance: Biologics, Formulation Development
Drug Substance: Small Molecule / APIDrug Substance: BiologicsFormulation DevelopmentOncologyCNS / NeurologySmall MoleculeMonoclonal Antibody (mAb)
Aenova Group
Unclaimed · public records
CDMO · Formulation Development, LNP / Delivery Formulation, Process Development
Formulation DevelopmentLNP / Delivery FormulationProcess DevelopmentOncologyImmunology & InflammationSmall MoleculeProtein / Enzyme (Recombinant)
Simtra BioPharma Solutions
Unclaimed · public records
CDMO · Formulation Development, LNP / Delivery Formulation, Process Development
Formulation DevelopmentLNP / Delivery FormulationProcess DevelopmentOncologyImmunology & InflammationSmall MoleculeMonoclonal Antibody (mAb)
Vetter Pharma
Unclaimed · public records
CDMO · Formulation Development, LNP / Delivery Formulation, Process Development
Formulation DevelopmentLNP / Delivery FormulationProcess DevelopmentOncologyImmunology & InflammationMonoclonal Antibody (mAb)Protein / Enzyme (Recombinant)
PCI Pharma Services
Unclaimed · public records
CDMO · Aseptic Fill-Finish, Drug Product Manufacturing, Formulation Development
Aseptic Fill-FinishDrug Product ManufacturingFormulation DevelopmentOncologyImmunology & InflammationAntibody-Drug Conjugate (ADC)Monoclonal Antibody (mAb)
LOTTE BIOLOGICS
Unclaimed · public records
CDMO · Drug Substance: Biologics, ADC / Bioconjugation, Cell Line / Strain Development
Drug Substance: BiologicsADC / BioconjugationCell Line / Strain DevelopmentOncologyHematologyMonoclonal Antibody (mAb)Antibody-Drug Conjugate (ADC)
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
Mabion
Unclaimed · public records
CDMO · Drug Substance: Biologics, Cell Line / Strain Development, Process Development
Drug Substance: BiologicsCell Line / Strain DevelopmentProcess DevelopmentOncologyImmunology & InflammationMonoclonal Antibody (mAb)Antibody-Drug Conjugate (ADC)
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)
GeneQuantum Healthcare
Unclaimed · public records
CDMO · ADC / Bioconjugation, Medicinal & Synthetic Chemistry, Process Development
ADC / BioconjugationMedicinal & Synthetic ChemistryProcess DevelopmentOncologyAntibody-Drug Conjugate (ADC)Monoclonal Antibody (mAb)
Axplora (formerly Novasep)
Unclaimed · public records
CDMO · ADC / Bioconjugation, Drug Substance: Small Molecule / API, Medicinal & Synthetic Chemistry
ADC / BioconjugationDrug Substance: Small Molecule / APIMedicinal & Synthetic ChemistryOncologyAntibody-Drug Conjugate (ADC)Small Molecule
AsymBio (Asymchem)
Unclaimed · public records
CDMO · ADC / Bioconjugation, Drug Substance: Biologics, Drug Substance: Small Molecule / API
ADC / BioconjugationDrug Substance: BiologicsDrug Substance: Small Molecule / APIOncologyAntibody-Drug Conjugate (ADC)Monoclonal Antibody (mAb)
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)
Levena Biopharma
Unclaimed · public records
CRO & CDMO · ADC / Bioconjugation, Medicinal & Synthetic Chemistry, Process Development
ADC / BioconjugationMedicinal & Synthetic ChemistryProcess DevelopmentOncologyAntibody-Drug Conjugate (ADC)Monoclonal Antibody (mAb)
Celonic
Unclaimed · public records
CDMO · Drug Substance: Biologics, Cell Line / Strain Development, Process Development
Drug Substance: BiologicsCell Line / Strain DevelopmentProcess DevelopmentOncologyImmunology & InflammationMonoclonal Antibody (mAb)Antibody-Drug Conjugate (ADC)
CARBOGEN AMCIS
Unclaimed · public records
CDMO · ADC / Bioconjugation, Drug Substance: Small Molecule / API, Medicinal & Synthetic Chemistry
ADC / BioconjugationDrug Substance: Small Molecule / APIMedicinal & Synthetic ChemistryOncologyAntibody-Drug Conjugate (ADC)Small Molecule
Cerbios-Pharma
Unclaimed · public records
CDMO · ADC / Bioconjugation, Drug Substance: Small Molecule / API, Drug Substance: Biologics
ADC / BioconjugationDrug Substance: Small Molecule / APIDrug Substance: BiologicsOncologyAntibody-Drug Conjugate (ADC)Small Molecule
MilliporeSigma (SAFC)
Unclaimed · public records
CDMO · ADC / Bioconjugation, Drug Substance: Small Molecule / API, Process Development
ADC / BioconjugationDrug Substance: Small Molecule / APIProcess DevelopmentOncologyHematologyAntibody-Drug Conjugate (ADC)Monoclonal Antibody (mAb)
FUJIFILM Biotechnologies
Unclaimed · public records
CDMO · Drug Substance: Biologics, ADC / Bioconjugation, Cell Line / Strain Development
Drug Substance: BiologicsADC / BioconjugationCell Line / Strain DevelopmentOncologyAntibody-Drug Conjugate (ADC)Monoclonal Antibody (mAb)
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)
MabPlex
Unclaimed · public records
CDMO · ADC / Bioconjugation, Drug Substance: Biologics, Cell Line / Strain Development
ADC / BioconjugationDrug Substance: BiologicsCell Line / Strain DevelopmentOncologyHematologyAntibody-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)
Senn Chemicals (Granules India)
Unclaimed · public records
CDMO · Peptide / Oligo Synthesis, Process Development, Analytical Development
Peptide / Oligo SynthesisProcess DevelopmentAnalytical DevelopmentMetabolic / EndocrinologyOncologyPeptide
Recipharm
Unclaimed · public records
CDMO · mRNA / RNA Manufacturing, LNP / Delivery Formulation, Drug Product Manufacturing
mRNA / RNA ManufacturingLNP / Delivery FormulationDrug Product ManufacturingInfectious DiseaseOncologymRNA / saRNASmall Molecule
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
Evonik (Health Care)
Unclaimed · public records
CDMO · LNP / Delivery Formulation, Formulation Development, Drug Product Manufacturing
LNP / Delivery FormulationFormulation DevelopmentDrug Product ManufacturingOncologyInfectious DiseasemRNA / saRNASmall Molecule
Merck Millipore (MilliporeSigma / Sigma-Aldrich CTDMO)
Unclaimed · public records
CDMO · mRNA / RNA Manufacturing, LNP / Delivery Formulation, Plasmid DNA Manufacturing
mRNA / RNA ManufacturingLNP / Delivery FormulationPlasmid DNA ManufacturingOncologyInfectious DiseasemRNA / saRNAPlasmid DNA
Fujifilm (Toyama Chemical / FUJIFILM Diosynth LNP)
Unclaimed · public records
CDMO · mRNA / RNA Manufacturing, LNP / Delivery Formulation, Aseptic Fill-Finish
mRNA / RNA ManufacturingLNP / Delivery FormulationAseptic Fill-FinishInfectious DiseaseOncologymRNA / saRNAVaccine
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)
CSBio
Unclaimed · public records
CDMO · Peptide / Oligo Synthesis, Process Development, Analytical Development
Peptide / Oligo SynthesisProcess DevelopmentAnalytical DevelopmentMetabolic / EndocrinologyOncologyPeptide
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
Northern RNA
Unclaimed · public records
CDMO · mRNA / RNA Manufacturing, LNP / Delivery Formulation, Plasmid DNA Manufacturing
mRNA / RNA ManufacturingLNP / Delivery FormulationPlasmid DNA ManufacturingInfectious DiseaseOncologymRNA / saRNAPlasmid DNA
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)
Polymun Scientific
Unclaimed · public records
CDMO · LNP / Delivery Formulation, mRNA / RNA Manufacturing, Formulation Development
LNP / Delivery FormulationmRNA / RNA ManufacturingFormulation DevelopmentInfectious DiseaseOncologymRNA / saRNAVaccine
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
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
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)
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)
RoslinCT
Unclaimed · public records
CDMO · Cell Therapy Manufacturing, Process Development, Analytical Development
Cell Therapy ManufacturingProcess DevelopmentAnalytical DevelopmentHematologyOncologyCell Therapy (CAR-T / NK / TIL)Gene Editing (CRISPR-based)
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)
Cellipont Bioservices
Unclaimed · public records
CDMO · Cell Therapy Manufacturing, Process Development, Analytical Development
Cell Therapy ManufacturingProcess DevelopmentAnalytical DevelopmentOncologyHematologyCell Therapy (CAR-T / NK / TIL)
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
Aldevron (Danaher)
Unclaimed · public records
CDMO · Plasmid DNA Manufacturing, mRNA / RNA Manufacturing, Process Development
Plasmid DNA ManufacturingmRNA / RNA ManufacturingProcess DevelopmentOncologyHematologyPlasmid DNAmRNA / saRNA
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)
Aldevron
Unclaimed · public records
CDMO · Process Development, Analytical Development, Plasmid DNA Manufacturing
Process DevelopmentAnalytical DevelopmentPlasmid DNA ManufacturingOncologyInfectious DiseasePlasmid DNAmRNA / saRNA
Polpharma Biologics
Unclaimed · public records
CDMO · Cell Line / Strain Development, Process Development, Analytical Development
Cell Line / Strain DevelopmentProcess DevelopmentAnalytical DevelopmentImmunology & InflammationOncologyMonoclonal Antibody (mAb)Protein / Enzyme (Recombinant)
Bora Biologics
Unclaimed · public records
CDMO · Cell Line / Strain Development, Process Development, Analytical Development
Cell Line / Strain DevelopmentProcess DevelopmentAnalytical DevelopmentOncologyImmunology & InflammationMonoclonal Antibody (mAb)Protein / Enzyme (Recombinant)
Binex
Unclaimed · public records
CDMO · Cell Line / Strain Development, Process Development, Analytical Development
Cell Line / Strain DevelopmentProcess DevelopmentAnalytical DevelopmentOncologyImmunology & InflammationMonoclonal Antibody (mAb)Protein / Enzyme (Recombinant)
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
Bionova Scientific
Unclaimed · public records
CDMO · Cell Line / Strain Development, Process Development, Analytical Development
Cell Line / Strain DevelopmentProcess DevelopmentAnalytical DevelopmentOncologyImmunology & InflammationMonoclonal Antibody (mAb)Bispecific / Multispecific Antibody
Wacker Biotech
Unclaimed · public records
CDMO · Process Development, Analytical Development, Drug Substance: Biologics
Process DevelopmentAnalytical DevelopmentDrug Substance: BiologicsInfectious DiseaseImmunology & InflammationProtein / Enzyme (Recombinant)Vaccine
Richter BioLogics (Richter-Helm)
Unclaimed · public records
CDMO · Process Development, Analytical Development, Drug Substance: Biologics
Process DevelopmentAnalytical DevelopmentDrug Substance: BiologicsInfectious DiseaseOncologyProtein / Enzyme (Recombinant)Peptide
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)
Avid Bioservices
Unclaimed · public records
CDMO · Process Development, Analytical Development, Drug Substance: Biologics
Process DevelopmentAnalytical DevelopmentDrug Substance: BiologicsOncologyImmunology & InflammationMonoclonal Antibody (mAb)Bispecific / Multispecific Antibody
Cytovance 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
GBI (Goodwin Biotechnology)
Unclaimed · public records
CDMO · Process Development, Analytical Development, Drug Substance: Biologics
Process DevelopmentAnalytical DevelopmentDrug Substance: BiologicsOncologyImmunology & InflammationMonoclonal Antibody (mAb)Protein / Enzyme (Recombinant)
BioVectra
Unclaimed · public records
CDMO · Process Development, Analytical Development, Drug Substance: Biologics
Process DevelopmentAnalytical DevelopmentDrug Substance: BiologicsOncologyMetabolic / EndocrinologyProtein / Enzyme (Recombinant)Peptide
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
Just - Evotec 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
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)
Wheeler Bio
Unclaimed · public records
CDMO · Cell Line / Strain Development, Process Development, Analytical Development
Cell Line / Strain DevelopmentProcess DevelopmentAnalytical DevelopmentOncologyImmunology & InflammationMonoclonal Antibody (mAb)Bispecific / Multispecific Antibody
Rentschler Biopharma
Unclaimed · public records
CDMO · Cell Line / Strain Development, Process Development, Analytical Development
Cell Line / Strain DevelopmentProcess DevelopmentAnalytical DevelopmentOncologyImmunology & InflammationMonoclonal Antibody (mAb)Bispecific / Multispecific Antibody
KBI Biopharma
Unclaimed · public records
CDMO · Cell Line / Strain Development, Process Development, Analytical Development
Cell Line / Strain DevelopmentProcess DevelopmentAnalytical DevelopmentOncologyImmunology & InflammationMonoclonal Antibody (mAb)Bispecific / Multispecific Antibody
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
Boehringer Ingelheim BioXcellence
Unclaimed · public records
CDMO · Cell Line / Strain Development, Process Development, Analytical Development
Cell Line / Strain DevelopmentProcess DevelopmentAnalytical DevelopmentOncologyImmunology & InflammationMonoclonal Antibody (mAb)Bispecific / Multispecific Antibody
WuXi 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
Samsung 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
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
Almac Group
Unclaimed · public records
CRO & CDMO · Medicinal & Synthetic Chemistry, Process Development, Drug Substance: Small Molecule / API
Medicinal & Synthetic ChemistryProcess DevelopmentDrug Substance: Small Molecule / APIOncologyCNS / NeurologySmall Molecule
Onyx Scientific (IPCA)
Unclaimed · public records
CDMO · Medicinal & Synthetic Chemistry, Process Development, Drug Substance: Small Molecule / API
Medicinal & Synthetic ChemistryProcess DevelopmentDrug Substance: Small Molecule / APIOncologyCNS / NeurologySmall Molecule
Laurus Labs (Laurus Synthesis)
Unclaimed · public records
CDMO · Medicinal & Synthetic Chemistry, Process Development, Drug Substance: Small Molecule / API
Medicinal & Synthetic ChemistryProcess DevelopmentDrug Substance: Small Molecule / APIInfectious DiseaseOncologySmall Molecule
Navin Molecular (Navin Fluorine)
Unclaimed · public records
CDMO · Medicinal & Synthetic Chemistry, Process Development, Drug Substance: Small Molecule / API
Medicinal & Synthetic ChemistryProcess DevelopmentDrug Substance: Small Molecule / APIOncologyCNS / NeurologySmall Molecule
F.I.S. (Fabbrica Italiana Sintetici)
Unclaimed · public records
CDMO · Medicinal & Synthetic Chemistry, Process Development, Drug Substance: Small Molecule / API
Medicinal & Synthetic ChemistryProcess DevelopmentDrug Substance: Small Molecule / APIOncologyCNS / NeurologySmall Molecule
PROCOS
Unclaimed · public records
CDMO · Medicinal & Synthetic Chemistry, Process Development, Drug Substance: Small Molecule / API
Medicinal & Synthetic ChemistryProcess DevelopmentDrug Substance: Small Molecule / APIOncologyCardiovascularSmall MoleculeAntibody-Drug Conjugate (ADC)
Sumitomo Chemical (Pharmaceuticals/CDMO)
Unclaimed · public records
CDMO · Process Development, Drug Substance: Small Molecule / API, Analytical Development
Process DevelopmentDrug Substance: Small Molecule / APIAnalytical DevelopmentOncologyCNS / NeurologySmall Molecule
Fermion (Orion Corporation)
Unclaimed · public records
CDMO · Process Development, Drug Substance: Small Molecule / API, Analytical Development
Process DevelopmentDrug Substance: Small Molecule / APIAnalytical DevelopmentOncologyCNS / NeurologySmall Molecule
Minakem (Minafin Group)
Unclaimed · public records
CDMO · Medicinal & Synthetic Chemistry, Process Development, Drug Substance: Small Molecule / API
Medicinal & Synthetic ChemistryProcess DevelopmentDrug Substance: Small Molecule / APIOncologyCNS / NeurologySmall Molecule
Curia (formerly AMRI)
Unclaimed · public records
CRO & CDMO · Target ID & Validation, Hit-to-Lead, Lead Optimization
Target ID & ValidationHit-to-LeadLead OptimizationOncologyCNS / NeurologySmall MoleculeMonoclonal Antibody (mAb)
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
Pfizer CentreOne
Unclaimed · public records
CRO & CDMO · Drug Substance: Small Molecule / API, Process Development, Analytical Development
Drug Substance: Small Molecule / APIProcess DevelopmentAnalytical DevelopmentInfectious DiseaseOncologySmall MoleculeMonoclonal Antibody (mAb)
Noramco
Unclaimed · public records
CDMO · Drug Substance: Small Molecule / API, Process Development, Analytical Development
Drug Substance: Small Molecule / APIProcess DevelopmentAnalytical DevelopmentCNS / NeurologyOncologySmall Molecule
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)
Divi's Laboratories
Unclaimed · public records
CDMO · Medicinal & Synthetic Chemistry, Process Development, Drug Substance: Small Molecule / API
Medicinal & Synthetic ChemistryProcess DevelopmentDrug Substance: Small Molecule / APIOncologyCardiovascularSmall MoleculePeptide
Dr. Reddy's Custom Pharma Services (CPS)
Unclaimed · public records
CRO & CDMO · Process Development, Drug Substance: Small Molecule / API, Analytical Development
Process DevelopmentDrug Substance: Small Molecule / APIAnalytical DevelopmentOncologyCardiovascularSmall MoleculePeptide
Piramal Pharma Solutions
Unclaimed · public records
CRO & CDMO · Hit-to-Lead, Lead Optimization, Medicinal & Synthetic Chemistry
Hit-to-LeadLead OptimizationMedicinal & Synthetic ChemistryOncologyCNS / NeurologySmall MoleculeAntibody-Drug Conjugate (ADC)
EUROAPI
Unclaimed · public records
CDMO · Drug Substance: Small Molecule / API, Process Development, Analytical Development
Drug Substance: Small Molecule / APIProcess DevelopmentAnalytical DevelopmentOncologyCardiovascularSmall MoleculePeptide
Seqens
Unclaimed · public records
CDMO · Medicinal & Synthetic Chemistry, Process Development, Drug Substance: Small Molecule / API
Medicinal & Synthetic ChemistryProcess DevelopmentDrug Substance: Small Molecule / APIOncologyCNS / NeurologySmall MoleculeAntibody-Drug Conjugate (ADC)
Olon Group
Unclaimed · public records
CDMO · Drug Substance: Small Molecule / API, Process Development, Analytical Development
Drug Substance: Small Molecule / APIProcess DevelopmentAnalytical DevelopmentOncologyInfectious DiseaseSmall MoleculePeptide
Fareva
Unclaimed · public records
CRO & CDMO · Drug Substance: Small Molecule / API, Process Development, Analytical Development
Drug Substance: Small Molecule / APIProcess DevelopmentAnalytical DevelopmentOncologyInfectious DiseaseSmall MoleculeProtein / Enzyme (Recombinant)
DOTTIKON ES
Unclaimed · public records
CDMO · Medicinal & Synthetic Chemistry, Process Development, Drug Substance: Small Molecule / API
Medicinal & Synthetic ChemistryProcess DevelopmentDrug Substance: Small Molecule / APIOncologyCNS / NeurologySmall Molecule
Hovione
Unclaimed · public records
CDMO · Drug Substance: Small Molecule / API, Process Development, Analytical Development
Drug Substance: Small Molecule / APIProcess DevelopmentAnalytical DevelopmentOncologyRespiratorySmall Molecule
CordenPharma
Unclaimed · public records
CRO & CDMO · Drug Substance: Small Molecule / API, Process Development, Analytical Development
Drug Substance: Small Molecule / APIProcess DevelopmentAnalytical DevelopmentOncologyMetabolic / EndocrinologySmall MoleculePeptide
Sterling Pharma Solutions
Unclaimed · public records
CDMO · Medicinal & Synthetic Chemistry, Process Development, Drug Substance: Small Molecule / API
Medicinal & Synthetic ChemistryProcess DevelopmentDrug Substance: Small Molecule / APIOncologyCNS / NeurologySmall MoleculeAntibody-Drug Conjugate (ADC)
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
Siegfried
Unclaimed · public records
CDMO · Drug Substance: Small Molecule / API, Process Development, Analytical Development
Drug Substance: Small Molecule / APIProcess DevelopmentAnalytical DevelopmentOncologyCNS / NeurologySmall Molecule
Cambrex
Unclaimed · public records
CDMO · Drug Substance: Small Molecule / API, Process Development, Analytical Development
Drug Substance: Small Molecule / APIProcess DevelopmentAnalytical DevelopmentOncologyRare / Orphan DiseaseSmall MoleculeAntibody-Drug Conjugate (ADC)
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)
Nucro-Technics
Unclaimed · public records
CRO & CDMO · GLP Toxicology, Genetic Toxicology, Bioanalytical Services
GLP ToxicologyGenetic ToxicologyBioanalytical ServicesOncologyImmunology & InflammationSmall MoleculePeptide
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
Aurigene Pharmaceutical Services
Unclaimed · public records
CRO & CDMO · Target ID & Validation, Assay Development & Screening, Hit-to-Lead
Target ID & ValidationAssay Development & ScreeningHit-to-LeadOncologyImmunology & InflammationSmall MoleculeMonoclonal Antibody (mAb)
Syngene International
Unclaimed · public records
CRO & CDMO · GLP Toxicology, Safety Pharmacology, DMPK / ADME
GLP ToxicologySafety PharmacologyDMPK / ADMEOncologyCNS / NeurologySmall MoleculeMonoclonal Antibody (mAb)
Aragen Life Sciences
Unclaimed · public records
CRO & CDMO · DMPK / ADME, GLP Toxicology, Safety Pharmacology
DMPK / ADMEGLP ToxicologySafety PharmacologyOncologyCNS / 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
Frontage Laboratories
Unclaimed · public records
CRO & CDMO · GLP Toxicology, Safety Pharmacology, Toxicokinetics (TK)
GLP ToxicologySafety PharmacologyToxicokinetics (TK)OncologyCNS / 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)
Pharmaron
Unclaimed · public records
CRO & CDMO · Clinical Operations, Clinical Data Management, Biostatistics & Statistical Programming
Clinical OperationsClinical Data ManagementBiostatistics & Statistical ProgrammingOncologyCNS / NeurologySmall MoleculeMonoclonal Antibody (mAb)
What is Analytical Development and when do you need it?
Analytical development is the part of CMC that builds the test methods used to describe your drug and prove it is what you say it is. Every release specification, every stability data point, every impurity limit rests on an assay that someone had to develop, qualify, and eventually validate. The deliverable is not material; it is a set of methods plus the data that shows they are accurate, precise, specific, and capable of detecting the things that would make a batch fail. Put plainly, you cannot release a batch you cannot measure, so analytical work tends to gate everything else in manufacturing.
You need it the moment a program moves from bench chemistry toward GMP material and the clinic. Early on, a method can be a development-grade HPLC run that tells your process chemist whether a step worked. As you approach a clinical batch, the same assays have to mature into qualified, then validated, methods that release drug substance and drug product and feed your IND Module 3. The work runs in parallel with process development and formulation, because the process keeps changing what the methods have to see, and stability cannot start until the stability-indicating methods exist.
What the assays look like depends heavily on modality. A small-molecule API leans on HPLC or UPLC for assay and related substances, Karl Fischer for water, residual-solvent GC under ICH Q3C, elemental impurities by ICP-MS under Q3D, and forced-degradation studies to prove the method is stability-indicating. A monoclonal antibody adds size-exclusion chromatography for aggregates, capillary electrophoresis and icIEF for charge variants, peptide mapping by LC-MS for identity and post-translational modifications, host cell protein ELISA, and residual host cell DNA by qPCR or ddPCR. Cell and gene therapy products carry their own potency and vector-characterization assays. The supplier pool that is excellent at one of these is rarely the right pool for another.
What does an Analytical Development CDMO actually do?
An analytical development group takes your molecule and builds the methods that will follow it through development, then runs them to generate the data a regulator expects. The work is phase-appropriate: methods are qualified for early clinical use and fully validated under ICH Q2(R2) for later phases and registration, against specifications shaped by ICH Q6A for small molecules or Q6B for biologics. A good group also owns method transfer, so an assay that worked at one site reproduces at the next without a surprise out-of-specification result.
Concretely, this is what buyers are sourcing under the Analytical Development heading:
- Method development: building identity, assay or potency, purity and related-substances, and impurity methods (HPLC, UPLC, CE, icIEF, GC, ICP-MS, ELISA, qPCR or ddPCR, mass spec) suited to your modality.
- Method qualification and validation: phase-appropriate validation under ICH Q2(R2) for specificity, accuracy, precision, linearity, range, detection and quantitation limits, and robustness.
- Release and characterization testing: the panel that releases a batch (identity, purity, potency, residuals, sterility-adjacent attributes) and the deeper structural characterization a biologic needs.
- Forced-degradation and stability-indicating method development: stressing the molecule (heat, light, acid, base, oxidation) so the method can detect real degradation products before stability runs.
- Impurity profiling and reference standards: characterizing process and degradation impurities under ICH Q3A/Q3B/Q3C/Q3D, and qualifying reference standards the methods depend on.
- Stability program support: protocol design and testing across ICH Q1A(R2) conditions to support shelf life and storage claims.
- Method transfer and tech transfer support: moving validated methods between your site, the drug-substance maker, and the release lab without re-developing them.
How do you choose an Analytical Development CDMO?
Start with modality fit, because the assay menu changes completely across small molecules, antibodies, peptides and oligos, viral vector, mRNA, and cell therapy. A lab that runs flawless small-molecule HPLC and residual-solvent GC may have never qualified a cell-based potency assay or a residual host cell DNA method, and those are exactly the assays that hold up an advanced-therapy filing. Ask to see relevant methods they have already validated in your modality, not a general capability slide.
Then weigh the quality grade you need now against where the program is going. Early development methods can run non-GMP, but release and stability testing for clinical material must sit under GMP in a quality system with documented OOS handling, change control, and an inspection history you can cite. The other practical filters decide whether the work runs on time and survives a transfer later:
- Quality and GxP status: GMP for release and stability testing, a working quality unit, documented OOS and deviation handling, and a clean inspection record from the agencies you plan to file with (FDA, EMA, PMDA).
- Capacity and lead time: real instrument and analyst availability, not a booked-out queue, plus a realistic timeline for development, validation, and the first release campaign.
- Modality and indication fit: demonstrated, validated methods in your specific modality and the impurity and potency assays it actually requires.
- Region and regulatory track record: experience supporting submissions in your target markets, and familiarity with USP, Ph. Eur., and JP compendial methods where they apply.
- Data quality and integrity: ALCOA-aligned records, validated software and audit trails (21 CFR Part 11), and stability-indicating methods backed by real forced-degradation data.
- IP and confidentiality: clear ownership of methods, data, and any reference standards developed, with confidentiality terms that protect a molecule you may not want disclosed.
- Method transferability: methods documented well enough to move cleanly to your drug-substance CDMO and release lab, so you avoid re-developing an assay mid-program.
Frequently asked questions
What is the difference between analytical development and process development?
Process development defines how you make the drug; analytical development defines how you measure it. The two run in parallel and feed each other, because every process change has to be confirmed by an assay, and you cannot set a control strategy for an attribute you cannot detect. In practice process and analytical groups share data constantly, and a release method is only as useful as the process it is checking. On BioBridgeX you can source both, either from one CDMO that does both well or from specialists, comparing quotes and contracting directly with your chosen supplier.
When does a method need to be validated versus just qualified?
It is phase-appropriate. Early in a program, methods are typically qualified, meaning you show they are fit for purpose to support early clinical material. As you move toward later-phase trials and registration, methods are fully validated under ICH Q2(R2), demonstrating specificity, accuracy, precision, linearity, range, detection and quantitation limits, and robustness. Paying for full validation on a method you may still change wastes money; carrying a method into a registration batch without validation is a filing risk. Decide the grade per method up front with the supplier.
What is a stability-indicating method and why does it matter?
A stability-indicating method can detect and quantify the degradation products that form as your drug ages or is stressed, separating them from the active molecule. You establish it through forced-degradation studies, stressing the molecule with heat, light, acid, base, and oxidation, then confirming the method picks up the resulting degradants. It matters because your stability program and shelf-life claim rest on it. If the method cannot see degradation, your stability data is reassuring for the wrong reason, and a regulator will say so.
Do biologics need different analytical development than small molecules?
Yes, substantially. Small molecules center on HPLC or UPLC assay and related substances, residual-solvent GC, elemental impurities by ICP-MS, and water by Karl Fischer. Biologics add a wider panel: size-exclusion chromatography for aggregates, capillary electrophoresis and icIEF for charge variants, peptide mapping by LC-MS for identity and modifications, host cell protein ELISA, residual host cell DNA by qPCR or ddPCR, and a potency assay tied to mechanism. The specifications follow ICH Q6B rather than Q6A. Match the CDMO to your modality, since the two skill sets rarely overlap.
Does analytical development need to run under GMP?
Not all of it. Early method development is usually non-GMP, because its job is to inform your process and formulation decisions. The line is crossed for testing that releases clinical material and for the stability program supporting it: that work must run under GMP, in a quality system with documented OOS handling, validated software, and an inspection history you can cite. A common sourcing question is where that line sits in your program and whether one supplier can carry you across it without a method transfer.
How does sourcing an Analytical Development CDMO through BioBridgeX work?
You describe the work (your modality, the methods you need, the quality grade, and the timeline) and get matched with qualified CDMOs that run that specific analytical work. You compare them on capability, validated methods in your modality, capacity, and transparent quotes side by side. BioBridgeX is free for buyers, suppliers pay a flat 2% success fee disclosed up front and owed only once they are paid, and when your program also touches process development, drug substance, or release testing you compare quotes and contract directly with each chosen supplier, in one place, with BioBridgeX as the neutral marketplace.
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