To accelerate the development and marketing of your Biotherapeutics, Quality Assistance offers a complete analytical package to meet the EMA and FDA requirements, all on one site.

Whether it is to extend your analytical capacities or to outsource parts or all of your analytical needs, our experts teams are here to support your developments of mAbs, ADCs and proteins.

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 biotherapeutics

  • 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) / 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)
Mass distribution profile Mass spectrometry (ESI-QTOF, MALDI-TOF) / SEC-(U)HPLC (UV, RI, MALS) / A4F
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
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