Cynomolgus Monkey IFNω Sequence for Antibody Safety Testing
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Solution Overview
Problem
Current toxicological testing strategies for human biologic proteins lack effective methods to assess the safety and efficacy of anti-human IFNω antibodies in non-human primate models due to the absence of cynomolgus monkey IFNω sequence information, limiting the development of in vitro assays for structural and functional homology assessment.
Innovation Solution
The development of isolated polynucleotides, recombinant vectors, and polypeptides encoding the cynomolgus monkey IFNω sequence, along with methods for expressing and determining cross-reactivity of human IFNω modulators with cyno IFNω, enabling the use of cynomolgus monkeys for pre-clinical studies by demonstrating functional activity and cross-reactivity with human IFNω.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current toxicological testing strategies are used for human biologic proteins, then testing can be performed without cynomolgus monkey IFNω sequence information, but the ability to assess safety and efficacy of anti-human IFNω antibodies in non-human primate models is limited
Solution Approach 1:
The patent applies preliminary action by first identifying and characterizing the cynomolgus monkey IFNω sequence before conducting toxicological studies. This preliminary sequence identification enables the subsequent development of validated in vitro assays and pre-clinical models, allowing safety and efficacy assessment to proceed with appropriate non-human primate models rather than being limited by absent sequence information
2Measurement precision
If in vitro assays are developed to assess structural and functional homology, then cross-reactivity of anti-human IFNω antibodies can be determined, but the absence of cynomolgus monkey IFNω sequence information prevents assay development
Solution Approach 1:
The patent applies copying by creating a cynomolgus monkey IFNω sequence that serves as a template or model for developing in vitro assays. This copied sequence information from the monkey genome enables the construction of assay systems that can measure cross-reactivity with human IFNω antibodies, providing a surrogate model that simplifies the complexity of direct in vivo testing while maintaining measurement precision
Data Source
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AI summary
Cytokine IFN? nucleic acids from the Cynomolgus monkey are useful for expression of IFN? proteins that are functional homologs of human IFN?. The nucleic acids and proteins produced therefrom are useful in screening and safety testing of IFN?, the generation and testing of IFN? modulators and related activities.