Anti-TRBV9 Antibody Composition Using Histidine Buffer Stability
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Solution Overview
Problem
Existing pharmaceutical compositions of anti-TRBV9 antibodies using citrate buffer are unstable, leading to aggregation issues, which compromises their stability and efficacy as a medicinal product for treating diseases mediated by T-lymphocytes bearing the TRBV9 segment within the T cell receptor.
Innovation Solution
Formulating anti-TRBV9 antibodies with histidine buffer and water for injection to create a stable pharmaceutical composition that maintains physical and chemical stability, ensuring long-term storage and therapeutic effectiveness.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If citrate buffer is used in the pharmaceutical composition, then the composition can be formulated with anti-TRBV9 antibody, but the composition becomes unstable and aggregates
Solution Approach 1:
The patent changes the buffer system parameter from citrate buffer to histidine buffer, which fundamentally alters the chemical environment to prevent antibody aggregation while maintaining formulation capability. This parameter change resolves the contradiction by finding a buffer condition that supports both manufacturability and long-term stability.
2Duration of action of stationary object
If the pharmaceutical composition is stored for long-term, then therapeutic effectiveness can be maintained, but aggregation occurs with citrate buffer reducing stability
Solution Approach 1:
By changing the buffer parameter from citrate to histidine, the patent extends the reliable storage duration of the antibody composition while maintaining therapeutic effectiveness. The histidine buffer creates a chemical environment that prevents aggregation over time, allowing long-term storage without compromising reliability.
3Ease of manufacture
If citrate buffer is used to formulate the antibody composition, then the composition can be prepared, but aggregation issues compromise its stability
Solution Approach 1:
The patent applies parameter change by substituting the buffer type from citrate to histidine, which maintains the ease of formulation process while dramatically improving physical stability. The histidine buffer system prevents aggregation and maintains antibody integrity throughout storage and handling.
Data Source
AI summary
The invention relates to the field of pharmacy and medicine, specifically to pharmaceutical compositions of anti-TRBV9 antibody. The invention further relates to the use of said compositions for treating a disease or disorder mediated by T-lymphocytes bearing a TRBV9 segment within the T cell receptor, in a subject in need thereof.