ADCs (Antibody-Drug Conjugates)

With a full analytical package for Biotherapeutics, Quality Assistance provides scientific and technical support to biopharmaceutical companies developing Antibody-Drug Conjugates.

Thanks to our combined experience with small molecule cytotoxics and monoclonal antibodies, we can provide full analytical support for your projects. We offer a wide range of services for all payload categories (maytansine derivatives, auristatins, etc.) and all conjugation strategies (lysine, cysteine, site-specific).

Throughout non-clinical and clinical development, our scientific team provides you with customised solutions in terms of analytical protocols and innovative technologies to help you move your product towards registration.

Your analytical partner providing:

  • customised solutions in terms of analytical protocols and innovative technologies throughout non-clinical and clinical development.

  • a full range of equipment in Chromatography, Mass Spectrometry, Biochemistry, Cell Biology, Pharmaceutical Technologies and Microbiology, to meet all the challenges of developing and validating methods.

  • regulatory, scientific and technical excellence with a problem-solving approach

  • compliance with all applicable EMA, FDA and ICH regulations

  • GMP, GLP, GCLP/GCP environment

Your one-stop shop for analytical services

Outsource your analytical needs on one site for more efficiency including:

  • Analytical development

  • Validation of analytical methods as per ICH guidelines

  • Characterisation of ADCs at intact, sub-unit and peptide levels

  • Bioassays

  • Bioanalytical services

  • Stability studies

  • Batch testing

pH / Osmolarity (if liquid)  
Water content / residual moisture (if lyophilised) KF titration (Volumetric, coulometric, oven)
Particulate matter Optical microscopy / Light obscuration / Imaging Particle Analysis
Properties after reconstitution  
Zeta potential  
Intact protein molecular weight Mass spectrometry (ESI-QTOF, MALDI-TOF) / 
Isoforms Mass spectrometry (ESI-QTOF, MALDI-TOF, ESI-IonTrap) / IEF / (i)cIEF / (U)HPLC (IEX, RP, SEC, HIC) / 2-D gel / Peptide mapping
Peptide mapping UPLC (UV, QTOF, IonTrap) / MALDI-TOF
Immunological identification ELISA / ECL (MSD) / Luminex / Western blotting / RID / Biacore / Octet (BLI)
Identification of linked cytotoxic payload UPLC (UV/MS)
N- and C-terminal sequencing ESI-IonTrap (ETD) / MALDI-TOF (ISD)
Protein quantity BCA / Lowry / Bradford / UV / (U)HPLC (UV) / Slope Spectroscopy (SoloVPE)
Absolute protein content determination ICP/MS (S, isotope dilution) / Amino Acid Analysis (AAA) by UPLC (UV or Fluo, ACCQ-TAG Ultra)
Determination of extinction coefficient UV + ICP-MS (S, isotope dilution) or AAA (UPLC-UV or Fluo)
Drug Antibody Ratio (DAR) (U)HPLC (UV) / UV/visible / HIC / Mass spectrometry (ESI-QTOF, MALDI-TOF, ESI-IonTrap) / SEC-HPLC (UV/RI/MALS) / A4F (UV/RI/MALS) / icIEF
Detection of free cytotoxic compound (U)HPLC (UV/MS) / UV / 2D-LC (UV/MS)
Mass distribution profile Mass spectrometry (ESI-QTOF, MALDI-TOF, ESI-IonTrap)
Structural integrity Circular Dichroism (CD) / FT-IR
Isoforms IEF / (i)cIEF / (U)HPLC (IEX, RP, SEC, HIC) / 2-D gel / Peptide mapping / Mass Spectrometry
Aggregation, fragment and particle size distribution SEC-(U)HPLC (UV, RI, MALS) / A4F / cGE / DLS / SDS-PAGE /
Imaging Particle Analysis
Glycosylation patterns UPLC (FLUO, QTOF, IonTrap) / MALDI-TOF / CE (LIF) / GC (MS)
Disulfide bridges SDS-PAGE / cGE / Peptide mapping
Free thiols Fluorescence (NPM) / UV (Ellman, DTNB)
Degradation patterns (oxidation, deamidation, Lys-term truncation, etc.) IEX / RP-(U)HPLC / SEC-(U)HPLC / SDS-PAGE / (U)HPLC (MS) / CE (icIEF, cGE) / 2D-Gel / Peptide mapping
Immunoassays / Cytotoxicity ELISA / ECL (MSD) / Luminex / Cell-based assays / FACS / Biacore / Octet (BLI)
Residual solvents HS-GC (FID, MS, ECD)
Residual proteins (including HCP, protein A, purification Ab) ELISA / ECL (MSD) / Luminex / UPLC (MS/MS) / Western blotting / 2D-Gel / 2D-DIGE
Buffer components (including BSA, Tween, β-OG, Antibiotics) ELISA / ECL (MSD) / Luminex / Colorimetry / (U)HPLC (UV, MS, RI, ELSD, CAD)
Antifoam agents (PPG, PEG, silicone oil) ICP (MS, OES) / (U)HPLC (ELSD, CAD)
Residual DNA Q-PCR / PicoGreen
Elemental impurities ICP (OES, MS)
Microbiology Bioburden / Sterility (filtration, direct inoculation)
Endotoxins and Pyrogens LAL (kinetic, end point), Monocyte Activation Test / 
Recombinant Factor C
Leachables and extractables GC (FID, ECD, MS) / ICP (OES, MS) / (U)HPLC (UV, ELSD, CAD, MS)
Container Closure System Integrity Bubbling / Dye ingress / Microbial ingress
Cytotoxicity / Biological reactivity Cell-based assays / USP <87>
Drug / Metabolites ELISA / ECL (MSD) / Luminex / UPLC (MS/MS) / ICP (OES, MS) / ESI-QTOF
Biomarkers ELISA / ECL (MSD) / Luminex / UPLC (MS/MS)
Vehicles / Buffers ELISA / ECL (MSD) / Luminex / (U)HPLC (UV, RI, DAD, FLUO, ELSD, CAD, MS) / ICP (OES, MS)
Immunogenicity ELISA / ECL (MSD) / Luminex / Cell-based assays (neutralisation) / Biacore
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