Anti-TIGIT Antibody Formulation for Non-Refrigerated Stability
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Solution Overview
Problem
Conventional pharmaceutical formulations for anti-TIGIT antibodies face challenges in maintaining physical and chemical stability, particularly under non-refrigerated conditions, leading to aggregation and degradation, necessitating stringent storage requirements.
Innovation Solution
A pharmaceutical formulation comprising an anti-TIGIT antibody, acetate or histidine buffer, sucrose or sorbitol as a stabilizer, and polysorbate 20 or polysorbate 80 as a surfactant, with specific pH and concentration ranges, ensuring stability under various environmental conditions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If protein liquid formulations are used for parenteral administration, then convenience of use is improved, but stability of the protein is worsened due to aggregation and degradation
Solution Approach 1:
The patent applies parameter changes by optimizing the formulation's pH to a specific range (5.0-6.5) and incorporating stabilizing agents at controlled concentrations. These parameter adjustments create a formulation environment that prevents protein aggregation and degradation while maintaining liquid formulation convenience for parenteral administration.
Solution Approach 2:
The patent introduces protective agents as intermediaries between the protein and the formulation environment. These stabilizing agents act as mediators that prevent direct harmful interactions between the protein and formulation components, thereby maintaining protein stability while preserving the liquid formulation's ease of administration.
2Stability of the object's composition
If protective agents are added to enhance protein stability, then stability is improved, but formulation complexity increases
Solution Approach 1:
The patent resolves formulation complexity by defining specific parameter ranges for stabilizing agents rather than requiring complex multi-component systems. By optimizing pH to 5.0-6.5 and using controlled concentrations of protective agents, the formulation achieves stability without excessive complexity in composition or preparation.
3Stability of the object's composition
If stringent storage conditions are imposed to maintain stability, then stability is improved, but ease of operation and storage flexibility is worsened
Solution Approach 1:
The patent enables storage flexibility by adjusting the formulation's pH to a relatively broad range (5.0-6.5) and incorporating stabilizing agents that maintain protein stability under varied storage conditions. This allows the formulation to remain stable without requiring stringent temperature control, thereby improving ease of storage while maintaining stability.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The formulation maintains high stability with minimal aggregation, turbidity, and pH drift, exhibiting superior thermostability and freeze-thaw stability, making it suitable for diverse storage conditions.
Implementation Method 1
the buffer is an acetate buffer or a histidine buffer
Implementation Method 2
the stabilizer is sucrose, sorbitol, or proline
Implementation Method 3
the surfactant is polysorbate 20 or polysorbate 80
Data Source
Figure 1a~2b
Figure 3a~4b
Figure 5a~5b
AI summary
A pharmaceutical preparation comprising an anti-TIGIT antibody, comprising an anti-TIGIT antibody, a stabilizer, a buffer solution, and a surfactant.