Liquid Anti-EBOV Antibody Formulation for Non-Refrigerated Use
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Solution Overview
Problem
There is a need for stable pharmaceutical formulations of anti-Ebola virus (EBOV) antibodies suitable for administration in remote environments lacking refrigeration, addressing issues of stability, degradation, and formulation suitability for patient use.
Innovation Solution
A stable liquid pharmaceutical formulation comprising a sugar, histidine buffer, and polysorbate as a cosolvent, with specific antibody concentrations and ratios, maintains antibody stability and suitability for administration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If therapeutic antibodies are formulated in liquid solution for administration, then the antibodies become suitable for patient use, but the antibodies are prone to degradation and aggregation
Solution Approach 1:
The patent applies parameter changes by carefully controlling the concentration ranges of excipients (sugar: 5-15%, buffer: 5-20 mM, cosolvent: 0.01-0.5%) and pH level (6.0-6.5) to optimize antibody stability in liquid formulation, preventing degradation and aggregation while maintaining administerability
Solution Approach 2:
The patent uses a composite formulation system combining multiple excipients (sugar, buffer, cosolvent) working synergistically to stabilize the antibody in liquid form, where each component contributes specific protective functions against degradation and aggregation
2Reliability
If the antibody concentration is increased to improve therapeutic efficacy, then the treatment effectiveness improves, but the formulation becomes more prone to aggregation and degradation
Solution Approach 1:
The patent optimizes the balance between antibody concentration and excipient concentrations by establishing specific ranges (antibody: 5-250 mg/mL, sugar: 5-15%, buffer: 5-20 mM, cosolvent: 0.01-0.5%) that maintain stability even at higher therapeutic concentrations
Solution Approach 2:
The patent employs established formulation strategies and excipient combinations that have been validated to maintain antibody stability, effectively copying proven formulation approaches adapted for anti-EBOV antibodies
3Ease of operation
If the formulation is designed for use in remote environments without refrigeration, then the accessibility and ease of use improve, but the formulation stability is compromised
Solution Approach 1:
The patent formulates the antibody with optimized excipient concentrations and pH levels that enhance thermal stability, allowing the formulation to remain stable at elevated temperatures (25-30°C) without requiring refrigeration, thus enabling use in remote environments
Solution Approach 2:
The patent incorporates excipients that proactively prevent aggregation and degradation mechanisms before they can occur during storage and transport in non-refrigerated conditions, maintaining antibody integrity throughout the supply chain
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 ensures stability and convenience of anti-EBOV antibodies, allowing for effective administration without refrigeration, with viscosity and concentration optimized for patient use.
Implementation Method 1
a stabilizer comprising a sugar
Implementation Method 2
a buffer comprising histidine
Implementation Method 3
an organic cosolvent comprising polysorbate
Data Source
AI summary
The present disclosure provides stable pharmaceutical formulations comprising a human antibody that specifically binds to Ebola Virus (EBOV). In certain embodiments, the formulations contain, in addition to an anti-EBOV antibody, a buffer, an amino acid, a non-ionic surfactant, and a stabilizer. The pharmaceutical formulations of the present disclosure exhibit a substantial degree of antibody stability upon stress, for example, agitation during transport, and storage, for example, storage at temperatures greater than 40° C.