Anti-PD-1 Antibody Formulation with Acetate Buffer for Tumor Immunotherapy
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Tumor immunotherapy faces challenges with immune escape mechanisms, where tumor cells inhibit the immune system, leading to a loss of killing function in killer T cells over time, due to the absence of a second signaling pathway for T cell activation.
Innovation Solution
A pharmaceutical composition comprising an anti-PD-1 antibody with specific heavy and light chain variable region sequences, formulated with an acetate buffer, histidine salt buffer, or succinate buffer at a pH of 4.5 to 6.0, and including an osmotic pressure regulator and surfactant, to effectively block the PD-L1/PD-1 binding and enhance immune response.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If tumor immunotherapy is used to kill tumor cells, then immune response is improved, but tumor cells develop immune escape mechanisms that inhibit the immune system
Solution Approach 1:
The patent uses anti-PD-1 antibody as an intermediary substance that blocks the interaction between PD-1 and PD-L1 proteins. This mediator prevents tumor cells from using the PD-1/PD-L1 pathway to suppress T cell activity, thereby counteracting the immune escape mechanism while maintaining the immune system's ability to kill tumor cells
2Stability of the object's composition
If anti-PD-1 antibody is formulated with buffer, then stability is improved, but pH control becomes critical to maintain biological activity
Solution Approach 1:
The patent specifies a controlled pH range of 4.5-6.0 for the buffer formulation, with preferred pH values of 4.7-5.7 and most preferably 5.2. This parameter control ensures the anti-PD-1 antibody maintains its biological activity and stability while preventing degradation that could occur at extreme pH values
3Reliability
If high concentration of anti-PD-1 antibody is used, then therapeutic efficacy is improved, but formulation complexity increases
Solution Approach 1:
The patent creates a composite pharmaceutical formulation by combining the anti-PD-1 antibody with multiple excipients including buffer (acetate, histidine salt, or succinate buffer), osmotic pressure regulators, and surfactants. This composite formulation achieves high antibody concentration (improved therapeutic efficacy) while maintaining stability and preventing aggregation through the synergistic effects of the various components
Data Source
AI summary
The present disclosure relates to an anti-PD-1 antibody pharmaceutical composition and use thereof. Specifically, the present disclosure provides a pharmaceutical composition, comprising an anti-PD-1 antibody and a buffer solution.