EVIOGEN DISCOVERY specializes in developing and validating robust analytical methods for a wide range of biologic modalities:

• Peptides
• Monoclonal and Polyclonal Antibodies
• Bi-Specific Antibodies
• Chemric Antigen Receptor T Cells (CAR-T) / TCR
• Biosimilars and Biobetters

Our scientific team possesses extensive experience in:

• Method Development: Custom assay design based on molecular & regulatory needs
• Method Transfer: Seamless transfer/optimization across platforms
• Method Optimization: Improved sensitivity, specificity, throughput
• Method Validation: Per FDA & EMA guidance
• Sample Analysis: High-throughput, high-precision analysis

Anti-Drug Antibody (ADA) Detection

Immunogenicity assessment is crucial for biologics, as anti-drug antibodies (ADAs) may neutralize therapeutic effects or cause adverse immune reactions.

EVIOGEN employs a bridging ELISA format for ADA screening in serum samples. In this method, ADAs form a molecular bridge between labeled drug molecules, enabling highly sensitive and specific detection.

• Assay Format: Bridging ELISA
• Detection Principle: ADA-mediated cross-linking of biotinylated & labeled drug molecules
• Validation: Strictly per FDA & EMA immunogenicity guidelines
• Project Duration: Approximately 25-30 weeks

Approximate project duration: 25-30 weeks

Quantitative Bioanalysis of Biologics

Accurate PK profiling is essential for evaluating ADME properties of biologic drugs. EVIOGEN has established optimized PK assays using the Sandwich ELISA platform.

• Assay Format: Sandwich ELISA
• Capture & Detection: Based on two monoclonal anti-idiotype antibodies
• Regulatory Compliance: Fully aligned with FDA & EMA validation guidelines

We have successfully developed and validated PK and ADA assays for the following biologics: