Execution
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 ligand binding based programs. Immunologix continues to build on our significant experience in:
- Optimal assay format selection
- Assay development and validation
- Critical Reagent characterization
- Impeccable regulatory and guidance adherence
- Execution and delivery of your quantitation data on time
Our Bioanalytical Process
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 structure, target, and matrix
- Focus on the most clinically-relevant aspects of assay
- Optimization of format, reagents, range, and sensitivity
- Systematic transfer from Development to Validation
Ligand Binding Based Quantitation Assay Formats
- Drug target capture
- Anti-drug idiotypic antibody capture
- Double antibody sandwich assay
- ELISA and ECL platforms
Validation
- Performance Evaluation to assure successful validation
- Performance characteristics meet regulatory requirements
- Validation Plans aligned with regulatory guidelines
- Qualification of minimum 2 scientists during validation
Instruments used in Bioanalytical Sciences
Perkin Elmer plate readers
Primary ELISA platform. Majority of assays, Multiple units for redundancy
MSD Sector 600
Industry-standard Electrochemiluminescence platform. Proven, Rugged, 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