mAbs (Monoclonal Antibodies)

Take no risk with your analytics when developing new therapeutic monoclonal antibodies. Our analytical teams take advantage of their extensive experience with the analysis of mAbs.

Throughout non-clinical and clinical development, our experts provide you with the customised solutions in terms of analytical protocols and innovative technologies to help you move your product from discovery to the market place.

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 mAbs

  • 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) / SDS-PAGE / cGE
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)
N- and C-terminal sequencing ESI-IonTrap (ETD) / MALDI-TOF (ISD) / Peptide mapping
Protein quantity BCA / Lowry / Bradford / UV / (U)HPLC (UV) / Slope Spectroscopy (SoloVPE)
Absolute protein content determination ICP-MS (S, isotope dilution) 
Determination of extinction coefficient UV + ICP-MS (S, isotope dilution) 
Mass distribution profile Mass spectrometry (ESI-QTOF, MALDI-TOF)
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, fragments 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 / Proliferative / Cell death / Cell migration / Cell receptor binding and activation / Reporter gene assays / etc. 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  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
Fill out this form to download this resource

Complete this form and access this document in seconds.