Freezing Immunogenic Emulsions for Cold Chain Stability
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Solution Overview
Problem
Immunogenic compositions, especially those with emulsions, face challenges in maintaining efficacy and stability due to temperature constraints, as freezing can damage adjuvant properties, and existing solutions like separate storage or ultra-low temperature methods are complex and costly or time-consuming.
Innovation Solution
Freezing immunogenic compositions based on single emulsions at a temperature below body temperature, which reverse at body temperature, allowing for storage at lower temperatures without significant loss of adjuvanting properties, and using a non-snap freezing process with a conventional freezer.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If immunogenic compositions are stored at low temperatures (2-8°C) to maintain adjuvant emulsion quality, then the emulsion quality is preserved, but the antigen stability deteriorates and immunogenic properties fall below adequate levels
Solution Approach 1:
The composition is divided into separate antigen and adjuvant components that are stored independently. The antigen is stored frozen at -196°C while the adjuvant emulsion is stored at 4°C, allowing each component to maintain its desired properties for many years without mutual interference
Solution Approach 2:
The antigen and adjuvant are prepared and stored in their optimal conditions beforehand (antigen frozen at -196°C, adjuvant at 4°C), and then rapidly mixed at the moment of administration to ensure both components are at peak efficacy
2Reliability
If antigens are stored separately from adjuvant emulsion to maintain antigen stability, then antigen stability is improved, but the time required to formulate and distribute the composition increases to 72-120 hours
Solution Approach 1:
Both the antigen and adjuvant are prepared and stored in their optimal conditions beforehand (antigen frozen at -196°C, adjuvant at 4°C), and then rapidly mixed at the moment of administration to ensure both components are at peak efficacy
Solution Approach 2:
The storage temperature parameter is changed for different components (antigen at -196°C, adjuvant at 4°C) to optimize stability, while the mixing process is accelerated by using pre-prepared components that can be rapidly combined
3Reliability
If ultra-low temperature storage (around -150°C) is used to maintain vaccine potency, then potency is preserved, but the method becomes very complex and expensive
Solution Approach 1:
The vaccine is segmented into antigen and adjuvant components stored at different temperatures, allowing the antigen to be stored at ultra-low temperature (-196°C) while the adjuvant is stored at more accessible temperatures (4°C), reducing overall system complexity
Solution Approach 2:
The adjuvant emulsion acts as an intermediary that can be stored at moderate temperatures and only needs to be mixed with the frozen antigen shortly before administration, simplifying the storage infrastructure requirements
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
This method extends the shelf-life of immunogenic compositions, maintains potency, and enables rapid availability in emergency situations without the need for complex equipment or trained operators, while preserving the adjuvanting properties of the emulsion.
Implementation Method 1
an emulsion which is a single emulsion at a first temperature below a body temperature of the animal and which emulsion reverses at a second temperature between the first temperature and the body temperature
Data Source
AI summary
The present invention pertains to a method for keeping an immunogenic composition available for administration to an animal, wherein said composition comprises an antigen and an emulsion which is a single emulsion at a first temperature below a body temperature of the animal and which emulsion reverses at a second temperature between the first temperature and the body temperature, said method comprising providing the composition, freezing the composition, and storing the frozen composition until it is needed for administration to the animal. The invention also pertains to a method for testing an immunogenic composition, and an immunogenic composition, optionally in combination with specific instructions for storing the composition.