Method Development
Our team develops bioassays tailored to your biologic’s unique characteristics, employing cutting-edge techniques for reliable and reproducible results.
- Potency Assays: Proliferation, anti-proliferation, neutralization (cell-based) to measure your biologic’s efficacy and strength.
- Complement Dependent Cytotoxicity (CDC)
- Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC)
- Antibody-Dependent Cell-Mediated Phagocytosis (ADCP)
- Binding Assay by ELISA: Direct and competitive assays to evaluate the binding capacity of your biologic to specific targets.
- C1q Binding Assays
- Complement Dependent Cytotoxicity (CDC)
- Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC)
- Binding Affinity Assays (SPR): Surface plasmon resonance (SPR) assays to measure binding kinetics and affinity between your biologic and its target molecules.
- FcγR (RIa, RIIa, RIIb, RIIIa & RIIIb) Binding Assays
- FcRn Binding Assays
- C1q Binding Assays
Method Qualification, Transfer & Validation
Once developed, bioassays must be qualified to ensure accuracy, precision, and robustness. Our qualification and verification services provide confidence in your assays’ performance:
- Qualification of Primary & Secondary Reference Standards (PRS/SRS): Establish and qualify reference standards to ensure your assays are consistent and reliable.
- Assay Transfer and Validation: Transfer bioassay methods seamlessly to new labs or facilities, ensuring they meet required regulatory standards.
- Qualification for Stability-Indicating Methods: Ensure your bioassays are capable of detecting stability changes over time, a critical part of stability studies.
At Aragen, we specialize in developing and qualifying bioassays to ensure the potency, efficacy, and safety of your biologic at every stage of development. From method development to qualification, our solutions deliver reliable, regulatory-compliant results to support your biologic’s successful transition from preclinical to clinical trials. Contact us today to learn how our bioassay services can accelerate your biologic’s path to market.