Anti-GM-CSF Antibody Liquid Formulation for High-Concentration Stability
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Solution Overview
Problem
Current treatments for inflammatory and autoimmune diseases, such as rheumatoid arthritis and multiple sclerosis, are limited in efficacy and can have significant side effects.
Innovation Solution
A liquid pharmaceutical formulation containing an anti-GM-CSF antibody, specifically designed to target human GM-CSF, which is formulated with a pH buffer, isotonicity modifier, and surfactant to ensure stability and effectiveness.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current treatments for inflammatory and autoimmune diseases are used, then disease symptoms can be suppressed, but significant side effects occur and efficacy is limited
Solution Approach 1:
The patent changes the molecular target parameter from conventional cytokine inhibitors to GM-CSF antibody, achieving superior efficacy in treating inflammatory and autoimmune diseases while reducing side effects. The specific antibody formulations with optimized concentrations (20-200 mg/ml) and pH conditions (4.5-7.5) demonstrate improved therapeutic reliability
Solution Approach 2:
The patent introduces anti-GM-CSF antibody as an intermediary substance that specifically binds to GM-CSF, blocking its pro-inflammatory effects. This intermediary approach provides targeted inhibition of the inflammatory cascade, improving efficacy while minimizing off-target side effects compared to conventional broad-spectrum immunosuppressants
2Reliability
If high concentration antibody formulation (20-200 mg/ml) is used, then treatment efficacy is improved, but formulation stability becomes more challenging
Solution Approach 1:
The patent optimizes multiple formulation parameters simultaneously: pH (4.5-7.5), ionic strength (130-250 mM isotonicity modifier), and surfactant concentration (0.01-0.03% w/v). These parameter changes enable stable high-concentration antibody formulations that maintain both efficacy and stability
Solution Approach 2:
The patent creates a composite formulation system combining anti-GM-CSF antibody with multiple excipients including pH buffers, isotonicity modifiers, and surfactants. This composite approach ensures formulation stability at high concentrations while maintaining therapeutic efficacy
Data Source
AI summary
The present disclosure provides a liquid pharmaceutical formulation comprising an antibody which binds specifically to human GM-CSF and further excipients, and methods of treating an inflammatory or autoimmune disease or condition using the same.