Comprehensive Immunogenicity Testing Services
Download our detailed capabilities overview to discover our immunogenicity testing expertise, featuring:
- Industry-leading ADA and NAb assay development and validation
- Dedicated cell lab for specialized NAb testing
- Multiple assay formats across key biological matrices
- Access to scientific consultation through office hours
Relevance
Our Science and Services
Immunologix has significant expertise in quantitation assays for a wide range of therapeutic modalities. Our scientists and principal Investigators have demonstrated experience and proficiency with LBA programs. Immunologix continues to build on our significant experience in:
- Bridging and direct binding based assays
- Ligand binding based neutralization assays
- Isotyping assays
- Supporting confirmation assays
- Anti-PEG assessment
- Pre-clinical and clinical studies
- Biosimilar studies
- In study cut point assessment
Our Immunogenicity Expertise
Dedicated LBA Laboratory
- Critical Reagent characterization
- Consistent, thorough Method Development process
- Performance characteristics meet/exceed regulatory requirements
- Performance Evaluation assures successful Assay Validation
- Sample Analysis for Pre-clinical and Clinical studies
Method Development
- Translational Sciences integration and planning
- Customized for your molecule and mechanism of action
- Focus on the most clinically-relevant aspects of assay
- Optimization of format, reagents, MRD, drug tolerance, Positive Control
- Preliminary cut point assessment and performance evaluation
- Systematic transfer from Development to Validation
Ligand Binding Based Quantitation Assay Formats
- Custom drug labeling
- PC characterization
- Optimal MRD and drug tolerance
- ACE and SPEAD adapted methods
- ELISA, ECL, and Flow Cytometry platforms
Validation
- Performance Evaluation to assure successful validation
- Validation Plans aligned with regulatory guidelines
- Qualification of minimum 2 scientists during validation
- Balanced design
- Cut point setting
Instruments used in immunogenicity
MSD Sector 600
Primary ADA platform. Industry-standard Electrochemiluminescence platform. Proven, Rugged, Multiple units for redundancy
Perkin Elmer plate readers
Primary ELISA platform., Multiple units for redundancy
Protein Simple Ella
Optional approach to standard ELISA for specific therapeutics or assay requirements. Multiple units for redundancy
Therapeutic modalities
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Monoclonal Antibodies -
Bi-Specific, Tri-Specific Fusion Proteins
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PEGylated molecules
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Peptides
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Biosimilars
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Exosomes
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Transgene proteins
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AAV Vectors
Other Fields of Expertise