Antibodies
Monoclonal antibodies (mAbs) are highly specific proteins designed to bind to a single target, such as a receptor on cancer cells or viruses. They are essential treatments in oncology, immunology and infectious diseases management. With their large therapeutic potential, mAbs represent both a scientific and technical challenge in drug development.
Structurally complex, analytically demanding
For over 20 years, we’ve supported biopharmaceutical innovators overcome the most complex challenges in monoclonal antibody development. From early-phase characterisation and stability studies to release testing, we help secure your molecule’s development.
At Quality Assistance, we provide you with the analytical data and expert support you need to bring your innovative medicine to market. We design and validate customised analytical approaches aligned with the unique attributes of your antibody. By combining rigorous methodologies with expert insights, we ensure your therapy meets the highest quality standards.
Related products
Analytical challenges we help you solve
The unique complexity of antibodies poses significant analytical questions related to their intricate structure, inherent heterogeneity and sensitivity to manufacturing processes. Their multi-domain protein structure demands advanced techniques to fully characterise Critical Quality Attributes.
Our fully integrated and EMA/FDA-compliant analytical services support your mAb development to overcome regulatory challenges and ensure you a successful development path.
Our analytical services include:
| Intact protein molecular weight | Mass spectrometry (ESI-QTOF, MALDI-TOF) / SDS-PAGE / cGE |
|---|---|
| Isoforms | Mass spectrometry (ESI-QTOF, MALDI-TOF) / IEF / icIEF / (U)HPLC (IEX, RP, SEC, HIC) / 2D gel / Peptide mapping |
| Peptide mapping | UPLC (UV, QTOF) / MALDI-TOF |
| Immunological identification | ELISA / ECL (MSD) / Luminex / Western blotting / SPR (Biacore) / BLI (Octet) |
| N- and C-terminal sequencing | Peptide mapping (UPLC - QTOF) / MALDI-TOF (ISD) |
| Protein quantity | BCA / Lowry / Bradford / UV / (U)HPLC (UV) / SoloVPE |
|---|---|
| Absolute protein content determination | ICP-MS (S, isotope dilution) |
| Determination of extinction coefficient | UV + ICP-MS (S, isotope dilution) |
| Mass distribution profile | Mass spectrometry (ESI-QTOF, MALDI-TOF) |
|---|---|
| Structural integrity | CD / FT-IR |
| Isoforms | IEF / icIEF / (U)HPLC (IEX, RP, SEC, HIC) / 2D gel / Peptide mapping / Mass spectrometry |
| Aggregation, fragments and particle size distribution | SEC-(U)HPLC (UV, RI, MALS) / AF4 / cGE / DLS / SDS-PAGE / Imaging Particle Analysis |
| Glycosylation patterns | UPLC (FLUO, QTOF) / MALDI-TOF / CE (LIF) / GC (MS) |
| Disulphide 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 (MAM using HRMS) |
| Immunoassays / Cytotoxicity / Proliferative / Cell death / Cell migration / Cell receptor binding and activation / Reporter gene assays | ELISA / ECL (MSD) / Luminex / Cell-based assays / FACS / SPR (Biacore) / BLI (Octet) |
| Residual solvents | HS-GC (FID, MS, ECD) |
| Residual proteins (including HCP, protein A, purification Ab) | ELISA / ECL (MSD) / Luminex / Gyrolab / UPLC (MS/MS) / Western blotting / 2D gel / 2D-DIGE |
| Buffer components (including BSA, Tween, β-OG, antibiotics) | ELISA / ECL (MSD) / Colorimetry / (U)HPLC (UV, MS, RI, ELSD, CAD) |
| Antifoam agents (PPG, PEG, silicone oil) | ICP (MS, OES) / (U)HPLC (ELSD, CAD) |
| Residual DNA | qPCR / ddPCR / PicoGreen |
| Elemental impurities | ICP (OES, MS) |
| Microbiology | Bioburden / Sterility (filtration, direct inoculation) |
| Endotoxins and pyrogens | LAL (kinetic, end point) / MAT / rFC |
| 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> |
| Break Loose and Glide Force (BLGF) for prefilled syringes |
Our technological platforms, your strategic advantage
Our technological platform is optimised for your antibody development and include:
- A wide range of High-Resolution Mass Spectrometry systems including QTOF, MALDI-TOF and BioAccord for intact mass, peptide mapping, glycosylation analysis and detailed structural analysis using, for example, Multi-Attribute Methods (MAM) for simultaneous determination of PTMs.
- (U)HPLC and CE capabilities for comprehensive protein characterisation, including peptide mapping and glycan profiling.
- Biacore T200 (SPR) and Octet RED96e (BLI) for precise assessment of binding kinetics and affinities.
- Multiplex immunoassays and cell-based assays (cytotoxicity, biomarker, ADA) for functional characterisation and immunogenicity risk evaluation.
- ICP-MS instrumentation for accurate profiling of elemental impurities and process-related contaminants, but also for absolute quantification of proteins and determination of extinction coefficients.
Bioanalytical services
At Quality Assistance, we provide comprehensive bioanalytical services tailored to the development of antibody-based therapeutics. Our expertise covers the full lifecycle from method development and validation (EMA/FDA-compliant) to pre-clinical and clinical study support under GLP and GCLP/GCP standards. We offer:
- Pharmacokinetic (PK/TK) & biomarker analysis: using advanced platforms like ELISA, MSD, Luminex, FACS, Gyrolab and UPLC-MS/MS, we accurately quantify drug concentration and biomarkers.
- Immunogenicity assessment: We proactively identify potential immunogenicity risks through a tiered approach, including ADA screening, confirmatory and neutralisation assays.
Why innovators choose us
One site. One partner. Zero compromise. By partnering with Quality Assistance, you benefit from:
- Analytical strategies directly tailored to your antibody complexity we develop customised analytical strategies that address mAb unique characteristics. We support the full development lifecycle of your molecule.
- A single-site laboratory for full traceability all analytical activities are centralised at a unique facility, ensuring end-to-end traceability and eliminating the risks associated with multi-sites outsourcing. This setup guarantees streamlined communication and efficient project management.
- Comprehensive GxP compliance: our laboratories operate under a unified GxP environment (GMP, GLP, GCLP/GCP), fully aligned with EMA, FDA, and ICH regulatory expectations. This guarantees the precision and readiness of your data.
- Proactive expertise in antibody analytics: we proactively invest in cutting-edge technologies such as high-resolution mass spectrometry, capillary electrophoresis, and SPR/BLI to support advanced antibody characterisation. Our scientific experts provide continuous guidance throughout your project.
Advance with confidence through analytical precision
At Quality Assistance, you benefit from a partner offering both CMC and bioanalytical services in one fully integrated solution, backed by over 40 years of expertise and complete regulatory compliance (EMA, FDA, ICH). By consolidating all required analyses within a single site environment, we help you manage complexity with confidence, minimise development risks and accelerate your time to patients. We partner with you to drive your antibodies success forward.