Proteins

Our customers trust our excellence and know-how in analysing their proteins. From discovery to the marketplace, Quality Assistance offers the services for all your analytical sourcing needs for your proteins development in a GMP, GLP, GCLP/GCP environment.

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 Mass Spectrometry, Physico-chemistry, Cell Biology, Molecular Biology 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 proteins
    • Absolute-quantification of proteins and determination of extinction coefficient
    • Identity
    • Glycosylation
  • 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 Fluoresence (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
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
Download the product sheet for more information