Interferon-beta Storage Housing Metal Removal
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Solution Overview
Problem
Interferon-β solutions tend to aggregate due to the presence of aggregating metals like iron, copper, nickel, and tungsten, leading to opalescence, particulate formation, and reduced bioavailability, which complicates storage and delivery.
Innovation Solution
A method and device for storing and delivering Interferon-β solutions that minimize the concentration of aggregating metals to less than 500 parts per billion, using a housing constructed from glass, metal, or plastic, which is cleaned to reduce metal contamination, ensuring less than 15% aggregation after storage, by employing techniques such as acid and basic washes to remove metals from contact surfaces.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If Interferon-β solution is stored in conventional containers, then storage is simple and cost-effective, but aggregating metals are released causing protein aggregation, opalescence, and reduced bioavailability
Solution Approach 1:
The patent extracts and removes aggregating metals from the storage system by using acid-washed glass containers that have been pre-treated to eliminate metal contaminants. The housing is specifically cleaned with acid solutions to remove metals like iron, copper, nickel, and tungsten that would otherwise leach into the Interferon-β solution and cause aggregation.
Solution Approach 2:
The patent introduces an intermediary substance (acid-washed glass surface) between the container and the Interferon-β solution. The acid-washing process creates a metal-free surface that prevents direct contact between aggregating metals and the protein solution, thereby preventing aggregation while maintaining solution stability.
2Manufacturing precision
If acid and basic washes are used to clean the housing, then metal contamination is reduced to less than 500 parts per billion, but the cleaning process becomes more complex and time-consuming
Solution Approach 1:
The patent applies preliminary action by pre-washing the housing with acid and base solutions during the manufacturing or preparation phase. This preliminary cleaning removes aggregating metals before the Interferon-β solution is introduced, ensuring that the housing is ready for use without requiring complex cleaning procedures at the point of administration.
Solution Approach 2:
The patent changes the chemical parameters of the housing surface through acid and base washing, transforming it from a metal-containing surface to a metal-free surface. This parameter change (removal of metal contaminants to less than 500 parts per billion) is achieved through controlled chemical treatment that modifies the housing properties without affecting its structural integrity.
3Stability of the object's composition
If metal concentration is reduced to less than 500 parts per billion, then protein aggregation is minimized to less than 15%, but the requirements for housing material and cleaning become more stringent
Solution Approach 1:
The patent applies local quality by treating only the specific areas of the housing that will contact the Interferon-β solution with acid and base washes. The internal surface of the housing is specifically cleaned to remove metals, while the external surfaces and non-contact areas maintain their original properties. This localized treatment achieves the required metal concentration reduction without requiring complete reconstruction or replacement of the housing.
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 solution effectively reduces aggregation to less than 15%, 10%, 5%, or 2% in Interferon-β solutions, maintaining bioavailability and ease of delivery by minimizing the release of aggregating metals into the solution during storage.
Implementation Method 1
the housing releases a concentration of an aggregating metal into the solution of less than 500 parts per billion
Data Source
AI summary
The method described herein reduces the amount of aggregating metal released into solutions of Interferon-.beta.