IntegrateRNA's team help you perform your immunology testing. Our global team of experts partner with you to develop the best translational path for your therapeutic, provide detailed regulatory expectations, and offer technical expertise in required assay formats. By using this comprehensive approach, you'll have the most rapid and cost-effective program possible, from Proof of Concept, through safety assessment, and eventually to the clinic.
Oligonucleotide-based therapeutics are being tested for an array of local and systemic therapeutic indications, and several compounds are approved for commercial use. As a drug class, these compounds are chemically synthesized, but have large molecular size and complex mechanism of action, and engage specific metabolic and immunologic pathways. Furthermore, given the distinct properties of the different compounds that are included in this drug class, the approach to assessing product immunogenicity should be carefully considered.
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, drug tolerance, positive control
- Preliminary cut point assessment and performance evaluation
- Systematic transfer from development to validation
Validation
- Performance evaluation to assure successful validation
- Validation Plans aligned with regulatory guidelines
- Balanced design
- Cut point setting
