Protein Formulation Stability Without Surfactants
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Solution Overview
Problem
Current protein formulations for storage, such as antibodies, often include stabilizing substances that can interfere with downstream processes, reducing efficiency and requiring removal before use, and fail to maintain stability across various temperatures.
Innovation Solution
A formulation containing an isolated protein in an aqueous solution with a pH of 4.0-8.0, without cryoprotectants or surfactants, that is stable for at least three weeks at -80° to 8° C, and can be stored with low salt concentrations, allowing for flexibility in processing and long-term stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If stabilizing substances (cryoprotectants or surfactants) are added to protein formulations, then protein stability is improved, but downstream processing efficiency is reduced and additional removal steps are required
Solution Approach 1:
The patent removes cryoprotectants and surfactants from the protein formulation entirely, extracting the harmful components while retaining the protein. This allows the protein to be stored without stabilizing agents that would interfere with downstream processing, eliminating the need for removal steps and improving overall processing efficiency.
Solution Approach 2:
The patent changes the formulation parameters by using simple aqueous buffers at specific pH levels (4.0-8.0) instead of complex stabilizing formulations. This parameter change maintains protein stability through pH control rather than through cryoprotectants or surfactants, thereby avoiding interference with downstream processes.
2Stability of the object's composition
If stabilizing substances are included in protein formulations, then protein stability is improved, but formulation complexity increases and additional removal steps are necessitated
Solution Approach 1:
The patent extracts and eliminates cryoprotectants and surfactants from the formulation, reducing complexity by removing unnecessary components. The simplified formulation contains only the protein and a basic aqueous buffer, eliminating the need for additional removal steps and streamlining the overall process.
Solution Approach 2:
The patent discards the need for complex stabilizing substances and recovers protein stability through simple pH control in aqueous buffers. This approach eliminates the cycle of adding stabilizers and then removing them, simplifying the formulation while maintaining protein stability.
3Duration of action of stationary object
If conventional protein formulations are used, then short-term storage is possible, but long-term stability across various temperatures cannot be maintained
Solution Approach 1:
The patent changes the formulation to use aqueous buffers at controlled pH levels (4.0-8.0), which provides temperature-independent stability. This parameter change enables the protein to maintain its structure and function across a wide temperature range (-80°C to 8°C) for extended periods, achieving both long-term storage and temperature stability.
Solution Approach 2:
The patent creates a universal formulation that works across multiple temperature conditions without requiring temperature-specific stabilizers. The simple aqueous buffer system provides multi-functional protection, maintaining protein stability whether stored at -80°C, -20°C, or 4°C, making the formulation adaptable to various storage environments.
Data Source
AI summary
Formulations are described that are suitable for storage of proteins, such as antibodies, over a relatively broad range of protein concentrations, pH, and buffer types. Also described are methods of storing a protein and methods of identifying a suitable formulation for storage of a specific protein. In general, a formulation contains low to no surfactant, no to relatively low salt concentrations, and requires a relatively low buffer concentration.