Biosimilar 3D ELISA
The Biosimilar 3D ELISA is a high-throughput assay designed for the detailed characterization and comparison of biosimilar monoclonal antibodies (mAbs) with their originator counterparts. This ELISA platform leverages three-dimensional structural recognition to assess antigen binding, Fc receptor interactions, and glycosylation patterns. Its precise sensitivity and specificity make it an indispensable tool for ensuring biosimilarity during drug development and regulatory submissions.
Content
- Purpose: The Biosimilar 3D ELISA is optimized to evaluate the critical quality attributes (CQAs) of therapeutic antibodies, such as their binding affinity, structural integrity, and post-translational modifications.
- Mechanism:
- The assay employs immobilized antigens and Fc receptors to mimic in vivo interactions.
- Secondary detection involves enzyme-linked antibodies, which provide quantitative readouts of binding efficiency and specificity.
- Format: This ELISA is typically available in 96-well and 384-well formats to accommodate varying throughput needs.
Applications
- Quality Control:
- Monitor batch-to-batch consistency in manufacturing.
- Regulatory Compliance:
- Generate robust data for biosimilar characterization and regulatory approval.
- Research and Development:
- Assess structure-function relationships during biosimilar development.
- Functional Analysis:
- Evaluate antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) via Fc receptor binding profiles.
This assay is critical for ensuring that biosimilars maintain the same safety, efficacy, and quality standards as their originator drugs.
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