ADCs (Antibody-Drug Conjugates)
With a full analytical package for Biotherapeutics, Quality Assistance provides scientific and technical support to biopharmaceutical companies developing Antibody-Drug Conjugates.
Thanks to our combined experience with small molecule cytotoxics and monoclonal antibodies, we can provide full analytical support for your projects. We offer a wide range of services for all payload categories (maytansine derivatives, auristatins, etc.) and all conjugation strategies (lysine, cysteine, site-specific).
Throughout non-clinical and clinical development, our scientific team provides you with customised solutions in terms of analytical protocols and innovative technologies to help you move your product towards registration.
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 ADCs at intact, sub-unit and peptide levels
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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) |
| Identification of linked cytotoxic payload | UPLC (UV/MS) |
| N- and C-terminal sequencing | ESI-IonTrap (ETD) / MALDI-TOF (ISD) |
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) |
| Drug Antibody Ratio (DAR) | (U)HPLC (UV) / UV/visible / HIC / Mass spectrometry (ESI-QTOF, MALDI-TOF, ESI-IonTrap) / SEC-HPLC (UV/RI/MALS) / A4F (UV/RI/MALS) / icIEF |
| Detection of free cytotoxic compound | (U)HPLC (UV/MS) / UV / 2D-LC (UV/MS) |
PURITY & INTEGRITY
| Mass distribution profile | Mass spectrometry (ESI-QTOF, MALDI-TOF, ESI-IonTrap) |
| 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, fragment 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 | 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 and extractables | 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 |
