Bispecific Antibody Analysis

Biochemistry Characterization

We offer a variety of biochemical characterization services for your BsAb, including purity measurements, molecular weight/mass measurements, and molecular structure analysis. Purity Measurement: We provide sodium-dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE) analysis, liquid chromatography-mass spectrometry (LC-MS) analysis and partial-filled affinity capillary electrophoresis (PFACE) analysis, allowing more accurate qualitative and quantitative analysis of antibodies. Molecular Weight/Mass Measurement: Techniques includes size exclusion chromatography, multi-angle light scattering (SEC-MALS), electrospray ionization mass spectrometry (ESI-MS), and electrospray ionization time of flight (ESI- TOF). Molecular Structure Analysis: Analysis methods includes nuclear magnetic resonance (NMR) spectroscopy, small-angle X-ray scattering (SAXS) and molecular docking analysis.

Stability Analysis

Our stability analysis consists of three main components:

• Polymerization Measurement: Various techniques such as dynamic light scattering (DLS), electrospray differential mobility analysis (ES-DMA), sedimentation velocity analysis, ultracentrifugation (SV-AUC) and field flow fractionation (FFF), etc.
• Thermal Stability Measurement: Temperature is an important environmental factor among many factors affecting protein aggregation. We offer several techniques for measuring the thermal stability of BsAb or other therapeutic molecules, including differential scanning calorimetry (DSC) and differential scanning fluorimetry (DSF).
• In Vitro Serum Stability Measurement: In vitro serum stability typically results in poor drug efficacy in vivo, even molecular toxicity, as well as plasma protein binding data. We provide technical assays such as enzyme-linked immunosorbent assay (ELISA) and flow cytometry for measurement.

Functional Analysis

• Affinity Measurement: Techniques such as surface plasmon resonance (SPR), ELISA-based analysis and flow cytometry analysis.
• ADCC Analysis: Typically, two types of effector cells, peripheral blood mononuclear cells (PBMC) and NK cells, are used for ADCC testing. We also offer high quality ADCC testing using the 51Cr method or the LDH method.
• CDC Analysis: Typically, CDC determines cell death by preloading target cells with radioactive compounds. We provide a highly reproducible CDC analysis for the analysis and interpretation of the cytotoxic effects of BsAb.
• ADCP Analysis: ADCP is a potentially powerful mechanism of action (MOA), which needs to be considered by the antibody drug developers and vaccine manufacturers when measuring product efficacy. We have developed a reporter gene detection method that can quickly and reliably measure the ADCP of a candidate drug.

PK / PD Analysis

In general, antibody drugs show more complex PK/PD characteristics than those of common small molecule drugs. Creative Biolabs provides BsAb absorption analysis, distribution analysis, metabolism and elimination analysis.

• Antibody Distribution: The distribution of BsAb is measured by the rate of extravasation in the tissue, the rate of distribution within the tissue, the rate and extent of antibody binding in the tissue, and the rate of tissue elimination. The rate of antibody clearance from the tissue can be measured primarily by convective elimination clearance and tissue catabolic rate within the tissue.
• Antibody Metabolism and Elimination: Metabolism of BsAb occurs in a range of body tissues and plasma. Through the pharmacokinetic model, the contribution of tissues such as skin, muscle, liver and intestine to the elimination of BsAb is analyzed. Mechanisms for drug elimination include filtration, secretion, and biotransformation.

Pre-clinical Study

To measure the efficacy and safety of drug candidates during drug development, a range of models are used at different stages, ranging from test tube experiments to cell cultures, animals and healthy human subjects. Creative Biolabs has built various models for your BsAb development.