Anti-IL-36R Antibody Formulation Stability
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Solution Overview
Problem
Therapeutic antibodies, such as anti-IL-36R antibodies, face challenges in stability and biological activity retention due to chemical and physical degradation during storage and administration, particularly in liquid formulations, leading to reduced efficacy and increased immunogenicity.
Innovation Solution
A stable liquid or lyophilized pharmaceutical formulation of anti-IL-36R antibodies is developed, incorporating a pharmaceutically acceptable buffer, tonicifying agent, stabilizing agent, and surfactant, optimized to maintain the antibody's biological activity and minimize aggregation, suitable for parenteral administration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If therapeutic antibodies are stored in liquid formulation, then ease of administration is improved, but stability and biological activity retention deteriorate due to chemical and physical degradation
Solution Approach 1:
The patent applies parameter changes by optimizing formulation conditions including pH (5.0-7.0), concentration (10-200 mg/mL), and adding specific excipients to stabilize the antibody structure and prevent degradation during storage and administration
Solution Approach 2:
The patent uses formulation excipients and additives as intermediary substances that mediate between the antibody and degradation processes, protecting the antibody from chemical and physical degradation while maintaining stability in liquid formulation
2Productivity
If antibody concentration is increased to reduce volume, then dosing efficiency is improved, but aggregation and precipitation increase
Solution Approach 1:
The patent optimizes concentration parameters within specific ranges (10-200 mg/mL) and adjusts formulation conditions including pH and excipient concentrations to maintain solubility and prevent aggregation at high antibody concentrations
Solution Approach 2:
The patent employs surfactants and other excipients as intermediary substances that prevent aggregation and precipitation by stabilizing the antibody surface and preventing harmful interactions at high concentrations
3Duration of action of stationary object
If formulation is optimized for stability, then shelf-life is improved, but formulation complexity increases
Solution Approach 1:
The patent extends shelf-life by optimizing storage parameters including temperature (2-8°C refrigeration), pH (5.0-7.0), and formulation composition, achieving stable storage for extended periods while maintaining antibody activity
Solution Approach 2:
The patent incorporates stabilizing excipients and additives in advance during formulation preparation that preemptively prevent degradation processes during storage, extending shelf-life before administration occurs
Data Source
AI summary
The present invention relates to anti-IL-36R formulations for administration to a subject.