Biotherapeutics
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:
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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 Chromatography, Mass Spectrometry, Biochemistry, Cell Biology, Pharmaceutical Technologies 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 biotherapeutics
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Bioassays
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Bioanalytical 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 / Electrochemiluminescence (MSD) / Luminex / UPLC (MS/MS) / ICP (OES, MS) / ESI-QTOF |
| Biomarkers | ELISA / Electrochemiluminescence (MSD) / Luminex / UPLC (MS/MS) |
| Vehicles / Buffers | ELISA / Electrochemiluminescence (MSD) / Luminex / (U)HPLC (UV, RI, DAD, FLUO, ELSD, CAD, MS) / ICP (OES, MS) |
| Immunogenicity | ELISA / Electrochemiluminescence (MSD) / Luminex / Cell-based assays (neutralisation) / Biacore |
