NBEs (New Biological Entities)

To speed up the development and marketing of your NBEs, Quality Assistance offers all analytical services required by EMA and FDA, all on one site. Whether it is to extend your analytical capacities or outsource parts or all of your analytical needs, our skilled teams are here to support your developments for 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 NBEs

  • Bioassays

  • Bioanalysis

  • Stability studies

  • Batch testing

MCB & WCB
Microbiology Bioburden / Sterility (filtration, direct inoculation)
Plasmid copy number Q-PCR
GENERAL QUALITY
Appearance  
pH / Osmolarity (if liquid)  
Water content / residual moisture (if lyophilised) KF / Coulometer
Particulate matter Optical microscopy / Light obscuration / Imaging Particle Analysis
Properties after reconstitution  
Zeta potential  
IDENTITY
Intact protein molecular weight Mass spectrometry (ESI-QTOF, MALDI-TOF) / 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) / Peptide mapping
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)
Structural integrity Circular Dichroism (CD)
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/HF5 (UV, RI, MALS) / CE / DLS / (SDS-)PAGE / Bioanalyzer / Imaging Particle Analysis
Glycosylation patterns UPLC (FLUO, QTOF, IonTrap) / MALDI-TOF / CE (LIF)
Disulfide bridges SDS-PAGE / Peptide mapping / Bioanalyzer
Free thiols Fluorescence (NPM) / UV (Ellman, DTNB)
Degradation patterns (incl. Met oxidation, Asn deamidation, 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
Enzymatic assays UV / Fluorescence / Luminescence
PROCESS-RELATED IMPURITIES
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 / Threshold (to be discussed)
Elemental impurities ICP(OES, MS)
Microbiology Bioburden / Sterility (filtration, direct inoculation)
Endotoxins LAL (kinetic, end point)
PACKAGING
Leachables 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
APIs / 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