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
![Lab equipment](https://www.immunologixlabs.com/wp-content/uploads/EQ-MSD-3-scaled.jpg)
MSD Sector 600
Primary ADA platform. Industry-standard Electrochemiluminescence platform. Proven, Rugged, Multiple units for redundancy
![Lab equipment](https://www.immunologixlabs.com/wp-content/uploads/EQ-MD-Spectramax-1-scaled.jpg)
Perkin Elmer plate readers
Primary ELISA platform., Multiple units for redundancy
![Lab equipment](https://www.immunologixlabs.com/wp-content/uploads/EQ-Ella-2-scaled.jpg)
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
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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