Vacuum Concentration of Protein Solutions With Controlled Viscosity
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Solution Overview
Problem
Current methods for delivering antibody-based therapeutics result in highly viscous solutions, leading to difficulties during bioprocessing, increased processing times, drug destabilization, and higher manufacturing costs due to high viscosities.
Innovation Solution
A method involving evaporative concentration under a vacuum of at least 100 mbar is applied to reduce the volume of viscous protein solutions or therapeutic formulations, achieving viscosities between 400 to 4000 mPa.s or cP, with optional stirring and temperature control to minimize foaming.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If evaporative concentration is applied to concentrate protein solutions, then the solution viscosity increases, but the processing difficulty and manufacturing costs increase
Solution Approach 1:
The patent applies vacuum pressure (below 100 mbar) during evaporative concentration to modify the physical parameters of the solution, allowing concentration to occur at lower temperatures and pressures. This parameter change enables achieving desired concentration levels while controlling viscosity increase, thereby resolving the contradiction between concentration and processing difficulty
Solution Approach 2:
The patent employs dynamic control of the concentration process by adjusting vacuum pressure levels and applying agitation at specific stages. The system transitions from high vacuum during initial concentration to reduced vacuum or atmospheric pressure during later stages, dynamically adapting processing conditions to maintain optimal viscosity and prevent excessive processing difficulty
2Quantity of substance
If high concentration is achieved through evaporative concentration, then the solution volume decreases, but the processing time increases
Solution Approach 1:
The patent implements periodic agitation during the evaporative concentration process, applying mechanical mixing at intervals rather than continuously. This periodic action enhances mass transfer and evaporation efficiency at different concentration stages, significantly reducing the total processing time required to achieve target concentration levels
Solution Approach 2:
The patent replaces purely thermal evaporation with a combined vacuum-evaporation-mechanical agitation system. The mechanical agitation component substitutes for extended thermal processing, accelerating the concentration rate and reducing processing time while maintaining product quality
3Productivity
If vacuum pressure is applied below 100 mbar, then the evaporation rate increases, but the foaming increases
Solution Approach 1:
The patent applies preliminary agitation before and during the early stages of vacuum evaporation to prevent foam formation. By pre-mixing the solution and applying controlled agitation during concentration, the system eliminates air pockets and reduces surface tension variations that cause foaming, thereby maintaining high evaporation rates without harmful foam generation
Solution Approach 2:
The patent uses mechanical agitation as an intermediary mechanism to control foam formation during vacuum evaporation. The agitation system acts as a mediator between the vacuum pressure and the solution, disrupting foam structures as they form and preventing excessive foaming while preserving the high evaporation rate enabled by vacuum conditions
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 method effectively reduces solution volume by up to 80% while maintaining desired viscosities, improving processing efficiency and reducing manufacturing costs.
Implementation Method 1
reducing a volume of the first solution via evaporative concentration, wherein a vacuum is applied during evaporative concentration of at least below 100 mbar
Implementation Method 2
a vacuum is applied during evaporative concentration of at least below 100 mbar
Data Source
AI summary
Some aspects of the present disclosure are directed towards the concentration or reduction of a solution, formulation, mixture, or compound comprising a protein conjugated to a polymer. In some embodiments, the method can involve applying a vacuum concentration process to the antibody conjugate comprising solution.