Squalene Adjuvant PCB Purification for Vaccine Safety
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Solution Overview
Problem
Vaccine adjuvants containing squalene can be contaminated with polychlorinated biphenyls (PCBs), which may inhibit the efficacy of vaccines by negatively affecting immune responses, highlighting the need for low or no PCB contamination in squalene-based adjuvants to ensure safe and effective immunization.
Innovation Solution
The development of an oil-in-water emulsion adjuvant using squalene with PCB levels below 661 picograms per gram (TEQ), achieved through purification or selection of low-PCB squalene sources, and the process involves mixing the squalene with an aqueous component and a surfactant, potentially using microfluidization to create submicron droplets, ensuring the adjuvant is free from specific PCB congeners like 3',4,4',5,5'-hexachlorobiphenyl, 3,3',4,4',5-pentachlorobiphenyl, and 3,4,4',5-tetrachlorobiphenyl.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If commercial squalene is used in adjuvant formulation, then the adjuvant can be produced with established supply chain, but PCB contamination occurs at high levels
Solution Approach 1:
The patent applies extraction by removing PCB contaminants from squalene through purification processes. The method extracts harmful PCB substances from the squalene matrix while retaining the beneficial adjuvant properties of squalene, thereby resolving the contradiction between ease of manufacture and PCB contamination.
Solution Approach 2:
The patent changes the purity parameter of squalene by establishing specific PCB concentration thresholds (e.g., less than 661 picograms per gram TEQ). This parameter change transforms commercial-grade squalene into purified squalene suitable for adjuvant formulation, eliminating harmful contamination while maintaining manufacturability.
2Ease of manufacture
If PCB-contaminated squalene is used in adjuvant, then manufacturing is simpler and less costly, but vaccine efficacy is inhibited due to negative immunological effects
Solution Approach 1:
The patent introduces purified squalene as an intermediary substance between the commercial squalene supply and the final vaccine formulation. This intermediary step removes PCB contaminants while preserving the adjuvant functionality, ensuring both manufacturing feasibility and vaccine efficacy.
Solution Approach 2:
The patent establishes critical parameter thresholds for PCB contamination levels that must be exceeded to ensure vaccine efficacy. By changing the purity parameters through purification processes, the patent ensures the squalene maintains both manufacturability and immunological effectiveness.
3Productivity
If standard squalene purification is used, then production efficiency is maintained, but PCB levels remain above safe thresholds for vaccine adjuvants
Solution Approach 1:
The patent applies preliminary action by implementing PCB removal processes before final adjuvant formulation. This preliminary purification step ensures that squalene meets strict PCB thresholds (less than 661 picograms per gram TEQ) before being used in vaccine production, maintaining both efficiency and precision.
Solution Approach 2:
The patent transforms the PCB contamination parameter from an unacceptable level to an acceptable level through controlled purification processes. This parameter change maintains production efficiency while achieving the manufacturing precision required for safe vaccine adjuvants.
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 resulting adjuvant composition effectively reduces the risk of adverse immunological effects, enhancing vaccine efficacy by minimizing PCB contamination, thereby ensuring a safer and more effective immune response.
Implementation Method 1
The mixing may involve microfluidisation e.g. to provide an emulsion with submicron droplets
Implementation Method 2
The mixing may involve microfluidisation e.g. to provide an emulsion with submicron droplets
Data Source
AI summary
When using squalene in a vaccine adjuvant, there is a possibility of contamination with polychlorinated biphenyls (PCBs). Environmental exposure to PCBs may adversely affect children's immune responses to routine vaccinations. Thus the invention uses squalene with low or no PCB contamination, particularly when derived from shark liver.