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Monoclonal Antibodies

With a full analytical package for Biologics, Quality Assistance provides scientific and technical support to biopharmaceutical companies developing new therapeutic monoclonal antibodies.
Throughout non-clinical and clinical development, our scientific team provides you with the customised solutions in terms of analytical protocols and innovative technologies to help you move your product towards registration.

Based on over 15 years’ expertise in Monoclonal Antibodies, our capabilities in this area are summarized in the following table:

MCB & WCB
Characterisation FACS / ICC (Immunocytochemistry)
Microbiology Bioburden / Sterility (filtration, direct inoculation) / Mycoplasma (QPCR)
Plasmid copy number Q-PCR
General Quality
Appearance Properties after reconstitution
pH, Osmolarity (if liquid) Zeta potential
Water content / residual moisture (if lyophilised) KF / Coulometer
Particulate matter Optical microscopy / Light obscuration / Imaging Particle Analysis
Identity
Intact protein molecular weight Mass spectrometry (ESI-QTOF, MALDI-TOF, ESI-Iontrap) / SDS-PAGE / Bioanalyzer
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
N- and C-terminal sequencing ESI-Iontrap (ETD) / MALDI-TOF (ISD)
Quantity
Protein quantity BCA / Lowry / Bradford / UV / (U)HPLC (UV)
Absolute protein content determination Amino Acid Analysis (AAA) by UPLC (UV or Fluo, ACCQ-TAG Ultra) / ICP/MS (S, isotope dilution)
Determination of extinction coefficient UV + ICP/MS (S, isotope dilution) or AAA (UPLC-UV or Fluo)
Purity & Integrity
Mass distribution profile Mass spectrometry (ESI-QTOF, MALDI-TOF, ESI- IonTrap)
Structural integrity Circular Dichroism (CD)
Isoforms IEF / (i)cIEF / (U)HPLC (IEX, RP, SEC, HIC) / 2D-Gel / Peptide mapping / Mass Spectrometry
Aggregation, fragments and particle size distribution SEC-(U)HPLC (UV, RI, MALS) / A4F/HF5 (UV, RI, MALS) / CE / DLS / (SDS-)PAGE / Bioanalyzer / Imaging Particle Analysis
Glycosylation patterns UPLC (FLUO, QTOF, IonTrap) / MALDI-TOF / CE (LIF) / GC (MS)
Disulfide bridges SDS-PAGE / Peptide mapping / Bioanalyzer
Free thiols Fluoresence (NPM)
Degradation patterns (oxidation, deamidation, Lys-term truncation, etc.) IEX / RP-(U)HPLC / SEC-(U)HPLC / (SDS-)PAGE / (U)HPLC (MS) / CE (icIEF, CE-SDS) / Bioanalyzer / 2D-Gel
Potency
Immunoassays / Cytotoxicity / Proliferative / Cell death / Cell migration / Cell receptor binding and activation / Reporter gene assays / etc. ELISA / ECL (MSD) / Luminex / Cell-based assays / FACS / Biacore
Process-related Impurities
Residual solvents HS-GC (FID, MS, ECD)
Residual proteins (incl. HCP, protein A, purification Ab) ELISA / ECL (MSD) / Luminex / UPLC (MS/MS) / Western blotting / 2D-Gel / 2D-DIGE
Buffer components (incl. BSA, Tween, ß-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 / Threshold (to be discussed)
Elemental impurities ICP(OES, MS)
Microbiology Bioburden / Sterility (filtration, direct inoculation)
Endotoxins LAL (kinetic, end point)
Packaging
Leachables and extractables GC (FID, ECD, MS) / ICP (OES, MS) / (U)HPLC (UV, ELSD, CAD)
Container Closure System Integrity Bubbling / Dye ingress / Microbial ingress
Cytotoxicity / Biological reactivity Cell-based assays / USP <87>
Pharmacokinetics & Toxicokinetics / Biomarkers / Immunogenicity
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 (neutralization) / Biacore

 

Resources

Webinar

News
News

Characterisation of monoclonal antibodies by Surface Plasmon Resonance (Biacore)
By Dr Fabian VANDERMEERS, R&D Technical Leader

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Fast and accurate absolute-quantification of proteins and antibodies using Isotope Dilution-Triple Quadrupole ICP-MS

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Mass Spectrometry as a powerful tool for the characterisation of monoclonal antibodies in the context of comparability studies

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News

News
 

 

State-of-the-Art MS Methods for Structural Assessment of mAbs and ADCs:
From the Research Lab to Routine Characterization

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2D-LC-MS for the Analysis of Monoclonal Antibodies and Antibody-Drug Conjugates in a Regulated Environment 

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