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Proteins

Thanks to over 30 years’ experience in analytical sciences and all our laboratories on one site, Quality Assistance covers all the analytical technologies needed to support your drug development process including protein characterisation, development and validation of analytical methods, stability studies, batch testing and bioanalysis to support PK/TK, biomarker and immunogenicity studies.

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

MCB & WCB
Microbiology Bioburden / Sterility (filtration, direct inoculation)
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) / 2-D 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, Q-TOF, IonTrap) / MALDI-TOF / CE (LIF) / GC (MS)
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
Enzymatic assays UV / Fluorescence / Luminescence
Process-related Impurities
Residual solvents HS-GC (FID, MS)
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) / AAS
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
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

 

Resources

Webinar

News

Mass Spectrometry toolkit for the characterisation of protein glycosylation
By Eric Largy, R&D Scientist

access-webinar-quality-assistance

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

access-webinar-quality-assistance

 

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