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:
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customised solutions in terms of analytical protocols and innovative technologies throughout non-clinical and clinical development.
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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.
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regulatory, scientific and technical excellence with a problem-solving approach
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compliance with all applicable EMA, FDA and ICH regulations
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GMP, GLP, GCLP/GCP environment
Your one-stop shop for analytical services
Outsource your analytical needs on one site for more efficiency including:
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Analytical development
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Validation of analytical methods as per ICH guidelines
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Characterisation of proteins
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Absolute-quantification of proteins and determination of extinction coefficient
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Identity
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Glycosylation
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Bioassays
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Bioanalyical services
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Stability studies
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Batch testing
GENERAL QUALITY
| Appearance | |
| 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 |
IDENTITY
| 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 |
QUANTITY
| 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) |
PURITY & INTEGRITY
| 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 |
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 / Octet (BLI) |
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 |
| Elemental impurities | ICP (OES, MS) |
| Microbiology | Bioburden / Sterility (filtration, direct inoculation) |
| Endotoxins and Pyrogens | LAL (kinetic, end point), Monocyte Activation Test, Recombinant Factor C |
PACKAGING
| 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> |
PHARMACOKINETICS & TOXICOKINETICS / BIOMARKERS / IMMUNOGENICITY
| 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 |
