Apeloa Pharmaceutical
Target ID & ValidationAssay Development & ScreeningHit IdentificationOncologyHematologySmall MoleculePeptide
Quick answer
Process development is the CMC work that turns a lab-scale recipe into a defined, repeatable manufacturing process: optimizing upstream and downstream unit operations, scaling up, and characterizing the process so it holds at GMP scale. You need it before clinical drug-substance batches. On BioBridgeX, buyers source and compare qualified CDMOs in one place.
Process Development CDMOs (152)
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)
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)
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)
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)
Formosa Laboratories
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
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)
Pierre Fabre CDMO (Saint-Julien-en-Genevois)
Unclaimed · public records
CDMO · Drug Substance: Biologics, ADC / Bioconjugation, Cell Line / Strain Development
Drug Substance: BiologicsADC / BioconjugationCell Line / Strain DevelopmentOncologyImmunology & InflammationMonoclonal 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)
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)
Synaffix (a Lonza company)
Unclaimed · public records
CDMO · ADC / Bioconjugation, Medicinal & Synthetic Chemistry, Process Development
ADC / BioconjugationMedicinal & Synthetic ChemistryProcess DevelopmentOncologyAntibody-Drug Conjugate (ADC)Bispecific / Multispecific Antibody
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
Acuitas Therapeutics
Unclaimed · public records
CDMO · LNP / Delivery Formulation, Formulation Development, Process Development
LNP / Delivery FormulationFormulation DevelopmentProcess DevelopmentInfectious DiseaseRare / Orphan DiseasemRNA / saRNAOligonucleotide (ASO / siRNA)
Genevant Sciences
Unclaimed · public records
CDMO · LNP / Delivery Formulation, Formulation Development, Process Development
LNP / Delivery FormulationFormulation DevelopmentProcess DevelopmentRare / Orphan DiseaseOncologymRNA / saRNAOligonucleotide (ASO / siRNA)
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
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)
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
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 Process Development and when do you need it?
Process development is the bench-to-batch work that takes a molecule someone made once, at small scale, and turns it into a process you can run the same way, at a useful scale, with results you can predict. In a discovery or research lab a protein gets expressed in a few shake flasks and purified by hand, or an API is made on a route that works for grams. None of that survives contact with a clinical batch. Process development is where a CDMO defines the actual unit operations, sets the operating ranges, and proves the process gives you the yield, purity, and quality you can defend later.
You typically need it once you have a locked candidate and you are heading toward GMP material for the clinic, so it sits squarely in the CMC stage, usually feeding the IND-enabling and Phase 1 supply effort. For a biologic the work splits into upstream (cell culture or fermentation: media and feed strategy, bioreactor conditions, titer) and downstream (harvest, capture chromatography, polishing steps, viral clearance, ultrafiltration and diafiltration, final formulation). For a small-molecule API it is route selection and optimization, reaction conditions, crystallization and polymorph control, and impurity fate-and-purge. Different modality, same goal: a process that is reliable, scalable, and characterized well enough that the next batch is not a surprise.
The reason teams treat this stage seriously is that everything downstream inherits it. Your analytical methods, your control strategy, your stability program, and eventually your Module 3 filing all rest on the process you define here. Cut corners in process development and you pay for it in failed engineering runs, a tech transfer that does not reproduce, or a comparability headache when you scale for Phase 3. Get it right and the GMP batches that follow are far less likely to slip your clinical timeline.
What does a Process Development CDMO actually do?
A process development group does the experimental work that converts a candidate into a manufacturable process and the documentation behind it. The exact menu depends on modality, but the shape is consistent: optimize the steps, understand which parameters matter, lock a control strategy, and transfer the process cleanly to the manufacturing floor. Most of this can run non-GMP, since the point is to define and de-risk the process before you commit to expensive GMP runs.
What you are buying is process knowledge, not just hands. A strong group uses design of experiments (DoE) to map how critical process parameters drive critical quality attributes, runs scale-down models so a 2 to 5 liter bench bioreactor predicts behavior at 200 or 2000 liters, and builds the process characterization that supports your eventual control strategy and process validation. For an API, that same discipline shows up as reaction kinetics, impurity tracking, crystallization and polymorph studies, and a route that is safe and economical at scale.
- Upstream development (biologics): cell line evaluation and fit, media and feed optimization, bioreactor scale-up, titer and productivity improvement, and harvest clarification.
- Downstream development (biologics): chromatography capture and polish, viral inactivation and filtration, UF/DF, and aggregate and impurity removal to hit your purity target.
- Process synthesis and optimization (small molecule): route scouting and selection, reaction optimization, crystallization and polymorph control, and impurity fate-and-purge studies.
- Process characterization and DoE: identifying critical process parameters and quality attributes, defining proven acceptable ranges, and building the control strategy.
- Scale-up and scale-down models: translating a bench process to pilot and engineering scale, with a representative scale-down model for later characterization.
- Formulation and developability support, coordinated with analytical development so you can measure what you make.
- Tech transfer: protocols, batch records, risk assessments, and on-floor support to move the process into engineering and GMP runs without losing yield or quality.
How to choose a Process Development CDMO?
The first filter is modality fit, and it is rarely close. A group that develops CHO-based monoclonal antibody processes every week is not the right home for an AAV gene therapy, an mRNA and LNP product, an autologous cell therapy, or a small-molecule API, and the reverse holds too. The unit operations, the scale-down models, and the analytical baggage differ completely. Match the CDMO to a process they run routinely, not one they are stretching to win.
After modality, the decision is mostly about whether the work will survive scale and transfer. The reason process development matters is that it feeds GMP manufacturing, so the partner that does it well is often the one that can also make your clinical material or hand off cleanly to the site that will. Ask how their process development connects to their GMP floor, how they document and de-risk tech transfer, and whether their scale-down model genuinely predicts the scale you need. Use this checklist when you compare suppliers:
- Quality and GxP status: confirm where the non-GMP development work ends and GMP begins, and that the same supplier (or a clean transfer) carries you across that line. Process development itself is usually non-GMP, but it has to set up GMP-ready manufacturing.
- Capacity and lead time: real availability and a realistic slot, plus turnaround on development runs. A great group booked solid for months can be slower than a good one with an open bench.
- Modality and indication fit: routine experience with your specific process (mAb, viral vector, mRNA/LNP, cell therapy, peptide, ADC, or small-molecule API), with relevant case studies, not a general capabilities deck.
- Region and regulatory track record: where the site sits, which agencies (FDA, EMA, PMDA) have inspected the connected GMP operation, and whether their process work has supported filings before.
- Data quality: clean DoE design, traceable process data, sound scale-down models, and honest reporting of runs that failed, because the failures tell you more than the wins.
- IP and confidentiality: clear ownership of process improvements and know-how, defined data and material transfer, and confidentiality terms you can live with on a process that is part of your asset's value.
Frequently asked questions
What is the difference between process development and manufacturing?
Process development defines and optimizes the process: it figures out the unit operations, operating ranges, and control strategy, and it proves the process scales and reproduces. Manufacturing then runs that defined process to make actual batches, under GMP once material is destined for patients. Development is mostly non-GMP and experimental; manufacturing is controlled and documented for release. The two are tightly linked, which is why many sponsors prefer a CDMO that can develop the process and then make the clinical material, so nothing is lost in a handoff between them.
Does process development need to be done under GMP?
Usually not. The point of process development is to define and de-risk the process before you commit to costly GMP runs, so the optimization, DoE, and scale-up work typically runs non-GMP. GMP applies once you make material that will go into a human and the testing that releases it. The practical sourcing question is where that line sits in your program and whether one supplier carries you across it, or a tech transfer to a GMP site is coming. Process development run well should leave you GMP-ready, even if the development work itself was not GMP.
What is upstream versus downstream process development?
For a biologic, upstream is everything that produces the molecule: cell culture or fermentation, media and feed strategy, bioreactor conditions, and the titer you can reach. Downstream is everything that purifies it: harvest and clarification, capture and polishing chromatography, viral inactivation and filtration, ultrafiltration and diafiltration, and final formulation. Upstream development chases productivity and consistent expression; downstream development chases purity, yield, and removal of aggregates, host-cell proteins, and other impurities. Both have to scale together, which is why they are usually developed in parallel by the same group.
How does tech transfer fit into process development?
Tech transfer is moving a defined process from where it was developed to where it will be run, whether that is from your lab to a CDMO, from development to the GMP floor, or from one site to another for scale. It is its own workstream: protocols, batch records, risk assessments, analytical method transfer, and on-floor support during the first runs. A weak transfer is where yield and quality quietly drop, so a CDMO whose development and manufacturing sit under one roof, or who documents transfer rigorously, lowers that risk. The fewer transfers your sourcing plan forces, the less exposure your clinical supply carries.
How long does process development take?
It depends heavily on modality and how mature your starting process is, so plan against your specific case rather than a generic number. A well-trodden monoclonal antibody or small-molecule API process is more predictable than a viral vector, mRNA and LNP, or cell therapy process, which tend to run longer and carry more uncertainty. Process development also rarely runs alone: analytical development moves in parallel because you cannot optimize what you cannot measure, and it feeds straight into engineering and GMP runs. Because it usually sits on the critical path into the clinic, locking a supplier and a slot early matters more than the headline duration.
Who owns the process know-how and IP we develop with a CDMO?
Settle this in writing before any work starts, because the optimized process is part of your asset's value. In a well-structured agreement the sponsor owns the process and improvements developed for the program, with clear terms on data and material transfer and on confidentiality. Watch for suppliers with platform technologies who may claim rights to platform-derived improvements, and confirm how the master cell bank, process records, and analytical methods get transferred to you or to your next site. Ambiguous ownership language is a red flag, since you may need to move this process to another manufacturer later.
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