Stabilizer-Carrier Biomolecule Sterilization
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Solution Overview
Problem
Current methods for sterilizing biopharmaceuticals often result in irreversible changes to active compounds, leading to reduced biological activity and increased risk of allergic reactions, and are costly due to the need for aseptic production or inadequate sterilization levels.
Innovation Solution
A closed sterilized container system using a stabilizer carrier with reversibly attached biomolecules, selected from (poly)peptides, amino acids, polyalcohols, polyethyleneglycols, ionic liquids, and saponins, which allows for terminal or bulk sterilization under non-sterile conditions, maintaining high biomolecule activity and stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional sterilization methods (ethylene oxide, heat, irradiation) are applied to biopharmaceuticals, then microbial contamination is removed, but the biological activity of the active compounds is reduced or lost
Solution Approach 1:
The patent applies preliminary action by incorporating stabilizers into the biomolecule formulation before sterilization. The stabilizers are pre-selected and pre-formulated with the active compound, creating a protected state that withstands subsequent sterilization processes. This allows terminal sterilization to be performed effectively while preserving biomolecule activity through the预先 established protective environment.
Solution Approach 2:
The patent uses stabilizers as intermediary substances that mediate between the sterilization process and the biomolecule. These stabilizers act as protective intermediaries that absorb or mitigate the harmful effects of sterilization methods (heat, irradiation, chemicals) on the biomolecule, allowing sterilization to occur without direct damaging contact with the active compound.
2Stability of the object's composition
If aseptic production is used to maintain biomolecule activity, then biological activity is preserved, but production costs increase significantly
Solution Approach 1:
The patent applies preliminary action by formulating stabilizers with the biomolecule before production, enabling subsequent terminal sterilization. This eliminates the need for costly aseptic production facilities and procedures, as the stabilizer-protected biomolecule can be manufactured under non-sterile conditions and then sterilized as a finished product, dramatically reducing manufacturing costs while preserving activity.
Solution Approach 2:
The patent changes the chemical parameters of the formulation by adding stabilizers that alter the biomolecule's susceptibility to sterilization damage. This parameter change enables the use of aggressive sterilization methods that would otherwise be incompatible with biomolecule stability, allowing terminal sterilization to replace expensive aseptic processes.
3Reliability
If standard sterilization methods are applied to ensure sterility, then pathogens are eliminated, but the biomolecules undergo irreversible changes and lose activity
Solution Approach 1:
The patent applies beforehand cushioning by incorporating stabilizers that create a protective environment around the biomolecule prior to sterilization. These stabilizers cushion the biomolecule against the harsh conditions of sterilization, absorbing stress and preventing irreversible structural changes while still allowing the sterilization process to achieve the required sterility assurance level.
Solution Approach 2:
The stabilizers serve as intermediary substances that stand between the sterilization process and the biomolecule, protecting the biomolecule's structural integrity while allowing effective pathogen elimination. The intermediaries transmit the sterilization effect to pathogens without transmitting damaging effects to the biomolecule.
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 system ensures high biomolecule activity retention after standard sterilization, reduces production costs by allowing non-sterile production, and enables long-term storage at room temperature without freezing, while ensuring the absence of viable pathogens.
Implementation Method 1
a stabilizer which partially or completely covers the attached biomolecules
Data Source
AI summary
The present invention, inter alia, relates to a closed sterilized container comprising at least one carrier which is a stabilizer; and at least one biomolecule reversibly attached to the carrier, wherein said carrier partially or completely covers the attached biomolecules and wherein said at least one carrier is selected from the group consisting of (poly)peptides such as dipeptides or tripeptides, amino acids, polyalcohols, polyethyleneglycols, ionic liquids, compatible solutes, saponins and a mixture thereof. The invention also relates to methods for producing sterilized containers according to the invention and uses thereof.