Apeloa Pharmaceutical
Target ID & ValidationAssay Development & ScreeningHit IdentificationOncologyHematologySmall MoleculePeptide
Quick answer
QC and release testing is the GMP-grade analytical work that decides whether a manufactured batch can be dosed in patients, checking identity, potency, purity, sterility, and endotoxin against an approved specification. You need it once material is made under GMP, from first clinical batch through commercial supply. On BioBridgeX, buyers source and compare qualified CDMOs and release labs in one place, free for buyers.
QC & Release Testing CDMOs (132)
Famar Group
Unclaimed · public records
CDMO · Formulation Development, LNP / Delivery Formulation, Process Development
Formulation DevelopmentLNP / Delivery FormulationProcess DevelopmentMetabolic / EndocrinologyCardiovascularSmall MoleculeProtein / Enzyme (Recombinant)
Nipro PharmaPackaging
Unclaimed · public records
CDMO · Drug Product Manufacturing, Aseptic Fill-Finish, QC & Release Testing
Drug Product ManufacturingAseptic Fill-FinishQC & Release TestingOncologyInfectious DiseaseSmall MoleculeProtein / Enzyme (Recombinant)
Emergent BioSolutions (CDMO Services)
Unclaimed · public records
CDMO · Process Development, Drug Substance: Biologics, Drug Product Manufacturing
Process DevelopmentDrug Substance: BiologicsDrug Product ManufacturingInfectious DiseaseImmunology & InflammationVaccineMonoclonal Antibody (mAb)
AbbVie Contract Manufacturing
Unclaimed · public records
CRO & CDMO · Drug Substance: Small Molecule / API, Drug Substance: Biologics, Formulation Development
Drug Substance: Small Molecule / APIDrug Substance: BiologicsFormulation DevelopmentOncologyImmunology & InflammationSmall MoleculeMonoclonal Antibody (mAb)
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)
Novocol Pharma
Unclaimed · public records
CDMO · Formulation Development, LNP / Delivery Formulation, Process Development
Formulation DevelopmentLNP / Delivery FormulationProcess DevelopmentMetabolic / EndocrinologyCNS / NeurologySmall MoleculeProtein / Enzyme (Recombinant)
Lifecore Biomedical
Unclaimed · public records
CDMO · Formulation Development, LNP / Delivery Formulation, Process Development
Formulation DevelopmentLNP / Delivery FormulationProcess DevelopmentOphthalmologyOncologySmall MoleculeProtein / Enzyme (Recombinant)
Kindeva Drug Delivery
Unclaimed · public records
CDMO · Formulation Development, LNP / Delivery Formulation, Process Development
Formulation DevelopmentLNP / Delivery FormulationProcess DevelopmentRespiratoryOncologySmall 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)
Jubilant HollisterStier
Unclaimed · public records
CDMO · Formulation Development, LNP / Delivery Formulation, Process Development
Formulation DevelopmentLNP / Delivery FormulationProcess DevelopmentOncologyInfectious DiseaseSmall MoleculeProtein / Enzyme (Recombinant)
Siegfried Holding
Unclaimed · public records
CRO & CDMO · Drug Substance: Small Molecule / API, Formulation Development, LNP / Delivery Formulation
Drug Substance: Small Molecule / APIFormulation DevelopmentLNP / Delivery FormulationOncologyCNS / NeurologySmall MoleculeProtein / Enzyme (Recombinant)
Aenova Group
Unclaimed · public records
CDMO · Formulation Development, LNP / Delivery Formulation, Process Development
Formulation DevelopmentLNP / Delivery FormulationProcess DevelopmentOncologyImmunology & InflammationSmall MoleculeProtein / Enzyme (Recombinant)
Fresenius Kabi Contract Manufacturing
Unclaimed · public records
CDMO · Formulation Development, LNP / Delivery Formulation, Process Development
Formulation DevelopmentLNP / Delivery FormulationProcess DevelopmentOncologyInfectious DiseaseSmall 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)
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)
Oncotec Pharma Produktion (medac group)
Unclaimed · public records
CDMO · Aseptic Fill-Finish, Drug Product Manufacturing, Formulation Development
Aseptic Fill-FinishDrug Product ManufacturingFormulation DevelopmentOncologyAntibody-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)
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)
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
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)
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)
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
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
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
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CDMO · Medicinal & Synthetic Chemistry, Process Development, Drug Substance: Small Molecule / API
Medicinal & Synthetic ChemistryProcess DevelopmentDrug Substance: Small Molecule / APIOncologyCNS / NeurologySmall Molecule
Hovione
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CDMO · Drug Substance: Small Molecule / API, Process Development, Analytical Development
Drug Substance: Small Molecule / APIProcess DevelopmentAnalytical DevelopmentOncologyRespiratorySmall Molecule
CordenPharma
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CRO & CDMO · Drug Substance: Small Molecule / API, Process Development, Analytical Development
Drug Substance: Small Molecule / APIProcess DevelopmentAnalytical DevelopmentOncologyMetabolic / EndocrinologySmall MoleculePeptide
Sterling Pharma Solutions
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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)
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CRO & CDMO · Medicinal & Synthetic Chemistry, Process Development, Analytical Development
Medicinal & Synthetic ChemistryProcess DevelopmentAnalytical DevelopmentOncologyHematologySmall MoleculePeptide
Asymchem
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CRO & CDMO · Medicinal & Synthetic Chemistry, Process Development, Drug Substance: Small Molecule / API
Medicinal & Synthetic ChemistryProcess DevelopmentDrug Substance: Small Molecule / APIOncologyMetabolic / EndocrinologySmall MoleculePeptide
Siegfried
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CDMO · Drug Substance: Small Molecule / API, Process Development, Analytical Development
Drug Substance: Small Molecule / APIProcess DevelopmentAnalytical DevelopmentOncologyCNS / NeurologySmall Molecule
Cambrex
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CDMO · Drug Substance: Small Molecule / API, Process Development, Analytical Development
Drug Substance: Small Molecule / APIProcess DevelopmentAnalytical DevelopmentOncologyRare / Orphan DiseaseSmall MoleculeAntibody-Drug Conjugate (ADC)
Lonza
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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)
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CRO & CDMO · Bioanalytical Services, Central Laboratory Services, Genetic Toxicology
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Nucro-Technics
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CRO & CDMO · GLP Toxicology, Genetic Toxicology, Bioanalytical Services
GLP ToxicologyGenetic ToxicologyBioanalytical ServicesOncologyImmunology & InflammationSmall MoleculePeptide
Abzena
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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
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CRO & CDMO · Target ID & Validation, Assay Development & Screening, Hit-to-Lead
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Syngene International
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CRO & CDMO · GLP Toxicology, Safety Pharmacology, DMPK / ADME
GLP ToxicologySafety PharmacologyDMPK / ADMEOncologyCNS / NeurologySmall MoleculeMonoclonal Antibody (mAb)
Aragen Life Sciences
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CRO & CDMO · DMPK / ADME, GLP Toxicology, Safety Pharmacology
DMPK / ADMEGLP ToxicologySafety PharmacologyOncologyCNS / NeurologySmall MoleculeMonoclonal Antibody (mAb)
Sai Life Sciences
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CRO & CDMO · DMPK / ADME, In Vitro / Early Toxicology, GLP Toxicology
DMPK / ADMEIn Vitro / Early ToxicologyGLP ToxicologyOncologyCNS / NeurologySmall MoleculePeptide
Frontage Laboratories
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CRO & CDMO · GLP Toxicology, Safety Pharmacology, Toxicokinetics (TK)
GLP ToxicologySafety PharmacologyToxicokinetics (TK)OncologyCNS / NeurologySmall MoleculeMonoclonal Antibody (mAb)
Charles River Laboratories
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CRO & CDMO · GLP Toxicology, Safety Pharmacology, Genetic Toxicology
GLP ToxicologySafety PharmacologyGenetic ToxicologyOncologyCNS / NeurologySmall MoleculeMonoclonal Antibody (mAb)
What is QC & Release Testing and when do you need it?
QC and release testing is the analytical gate every batch has to pass before it can be dosed in a patient. A manufacturer makes drug substance or drug product, then a quality control lab runs the batch against an approved specification: a defined list of tests, methods, and acceptance criteria. Every result has to fall inside the limits, the batch record has to be reviewed, and a quality unit (in the EU, a Qualified Person) has to sign the release before the material can ship or go into a trial. No clean release, no dosing. That is the whole point of the workstream.
The release panel depends on the product, but the spine is consistent. Identity confirms the molecule is what the label says. Assay and potency confirm strength, whether that is an HPLC content assay for a small molecule or a cell-based bioassay for a biologic. Purity and impurities cover related substances, aggregates, residual solvents, host-cell protein and DNA, and process residuals. For sterile products you add the safety tests: sterility (USP <71> or EP equivalent), bacterial endotoxin (USP <85>, typically LAL), bioburden, and container-closure integrity. Appearance, pH, osmolality, particulate matter, and uniformity round out a typical drug-product spec.
You need release testing the moment material is made under GMP, which for most programs is the first clinical batch, and it never stops after that. The same discipline carries through Phase 1 supply, scale-up, registration batches, and routine commercial release, with the specification tightening and the methods getting formally validated as the program matures. Early development assays can run non-GMP, but anything that releases material for a human has to run under GMP with validated, often compendial, methods. Plan release testing as a recurring obligation, not a one-time event, because every campaign generates batches that each need their own certificate of analysis.
What does a QC & Release Testing CDMO actually do?
A release lab does more than run instruments. It develops or transfers the methods, validates them to ICH Q2 expectations, qualifies reference standards, runs the release panel under GMP, and issues a certificate of analysis the sponsor or its Qualified Person relies on to release the batch. Many of these suppliers are the analytical arm of a CDMO that also makes the material, but a large share of the market is standalone contract QC labs that test product made elsewhere, which is common when a sponsor wants an independent lab or a second site for redundancy.
Two pieces of the work decide whether a program runs smoothly, and both happen before any routine batch is tested. The first is method transfer: moving a validated method from your development lab or your drug-substance site into the release lab so it performs the same way in their hands, with a documented transfer protocol and acceptance criteria. The second is handling the result that falls outside the limit. A good lab runs a disciplined out-of-specification (OOS) investigation under a Phelps-style root-cause process, distinguishes a real failure from a lab error, and documents it so the conclusion holds up in an inspection. How a supplier handles an OOS tells you more about them than a clean run ever will.
- Identity and strength: HPLC or UPLC assay, mass spec, peptide mapping, cell-based or binding potency assays for biologics
- Purity and impurities: related substances, aggregates (SEC), charge variants, residual solvents (GC headspace), host-cell protein and residual DNA, elemental impurities (ICP-MS)
- Sterility and safety: sterility (USP <71> / EP 2.6.1), bacterial endotoxin (USP <85> LAL), bioburden, mycoplasma and adventitious agents for biologics
- Physical and container tests: appearance, pH, osmolality, sub-visible particulates, uniformity of dosage units, container-closure integrity (CCIT)
- Method work: method development, validation to ICH Q2, method transfer and verification, forced-degradation and specificity studies
- Quality deliverables: GMP certificate of analysis, OOS and OOT investigations, reference standard qualification, stability-indicating method support
How to choose a QC & Release Testing CDMO?
Two filters do most of the work: does the lab have the right GMP quality grade and inspection history for where you plan to file, and does it actually run your kind of method on your kind of product. A lab that releases small-molecule oral solids every day may be a poor fit for a cell-based potency assay or a viral-vector release panel. Match the assay menu and the modality first, then look at capacity, turnaround, and how the lab behaves when a result goes sideways. Sterility and endotoxin results in particular sit on the critical path to release, so a realistic turnaround on those tests, not the headline price, is often what determines when your batch ships.
Run a short checklist before you commit. The cost of choosing wrong here is not a bad quote, it is a held batch, a failed transfer, or a finding you cannot defend in an inspection.
- Quality and GxP status: confirm GMP certification, the inspection history, and which agencies (FDA, EMA, PMDA) have audited the site, since you need to cite this lab in a filing
- Capacity and lead time: ask for realistic turnaround on the rate-limiting tests (sterility runs 14 days, endotoxin and bioburden have their own queues) and whether they have an open slot for your batch schedule
- Modality and indication fit: confirm the lab runs your specific methods (cell-based potency, peptide mapping, AAV titer, residual testing) routinely, not as a stretch
- Region and regulatory track record: match the lab to where you will release and file, and check it can support Qualified Person release for EU supply if you need it
- Data quality and integrity: validated methods to ICH Q2, sound method-transfer protocols, a disciplined OOS process, and data-integrity controls that survive an audit
- IP and confidentiality: clear terms on your methods, specifications, and results, and confidentiality on a product or indication you may not want disclosed
Frequently asked questions
What is the difference between QC release testing and stability testing?
Release testing confirms a batch meets its specification at the moment you release it, so it can be dosed or shipped. Stability testing tracks the same batch over time, held at controlled temperature and humidity, to establish shelf life and a retest date. They share many of the same methods (assay, purity, related substances), but release is a one-time pass-or-fail gate per batch, while stability is a scheduled program that pulls samples at intervals for months or years. Most sponsors source both, often from the same lab so the methods stay consistent.
Does QC and release testing have to be done under GMP?
Yes, for any material that will be dosed in a human. Release testing falls under GMP (Good Manufacturing Practice), the same quality system that governs the manufacturing, and the methods generally have to be validated to ICH Q2. Early development and characterization assays can run non-GMP before you transition, but the panel that actually releases a clinical or commercial batch must run under GMP with a quality unit reviewing and signing off. GMP here is distinct from the GLP that governs your tox studies and the GCP that governs the clinic.
How long does batch release testing take?
It depends on the panel, but sterility is almost always the rate-limiter. A compendial sterility test (USP <71>) runs a 14-day incubation, so even when every other test is fast, a sterile product cannot be released until that read is complete unless you have a validated rapid microbiological method. Endotoxin, bioburden, and chemistry tests are quicker but have their own queues. When you scope a release lab, ask for turnaround on the slowest test on your spec and schedule backward from your dosing date, because that is what sets your real release timeline.
What happens when a release test result is out of specification (OOS)?
The lab runs a formal OOS investigation before anything is released or rejected. The first step is a laboratory investigation to rule out an assignable cause such as analyst error, equipment fault, or a sample problem. If no lab error is found, the investigation extends to manufacturing to look for a true product failure. The batch cannot be released on a passing retest alone; the conclusion has to be documented and scientifically sound. How a lab handles OOS is one of the best signals of its quality maturity, and it is worth asking about before you sign.
Can I use an independent lab to release product made at a different CDMO?
Yes, and many sponsors do. Standalone contract QC labs routinely test and release product manufactured elsewhere, which is common when you want an independent release lab, a second site for redundancy, or a specialist for one assay your manufacturing CDMO does not run in-house. The key is a clean method transfer so the release lab reproduces your validated methods, plus clear agreement on who owns the certificate of analysis and the final release decision. On BioBridgeX you can source the release lab separately from the manufacturer and still contract once.
Who can release a batch for the clinic or market?
The release decision sits with the sponsor's quality unit. In the EU and UK, a named Qualified Person (QP) has to certify each batch before it can be used in a trial or sold, a legal role with personal accountability. In the US there is no QP equivalent, but a quality unit must review the batch record and release results against the specification before the batch is dosed or distributed. The contract lab generates and reports the data; the release sign-off is a quality-unit responsibility, so confirm up front whether you need QP release for EU supply.
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