Understanding the biological activity and mechanism of action of your biologic is critical for demonstrating its therapeutic potential. Aragen offers extensive biological and functional testing to evaluate key properties like biological activity and binding affinity.
With a team of experienced scientists and state-of-the-art technologies, Aragen ensures your biologic product is fully characterized and ready for clinical trials or market release. Our team has developed a suite of platforms to evaluate the function of the therapeutics, offering both ready-to-use and customizable cell-based assays and binding assays. This approach saves you time while ensuring a thorough characterization of your molecule. With our in-depth Product Development services, you can have confidence in the quality, stability, and performance of your biologic from discovery through to commercialization.
Below are the guidelines we follow in our day-to-day bioassay activities.
ICH Q14R1: Analytical procedure development,
ICH Q2R2: Validation of Analytical Procedures
USP <1032> Design And Development Of Biological Assays
USP <1033> Biological Assay Validation
USP <1034> Analysis Of Biological Assays
| Cell based assay | Binding Assay (ELISA) | Binding Affinity and Kinetics by SPR |
|---|---|---|
| Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) | Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) | FcγR Binding Assays
|
| Antibody-Dependent Cell-Mediated Phagocytosis (ADCP) | Antibody-Dependent Cell-Mediated Phagocytosis (ADCP) | FcRn Binding Assays |
| C1q cell-based assay | C1q Binding Assays | C1q Binding Assays |
| Complement Dependent Cytotoxicity (CDC) | Complement Dependent Cytotoxicity (CDC) | Fab Binding Affinity (Molecule specific) |
| Neutralization Assay | Neutralization Assay | – |