Adjuvant
A substance that enhances the body’s immune response to an antigen. Can be found in vaccines.
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Alum-precipitated
A process whereby an aqueous allergen extract is allowed to complex with an aluminum salt complex (e.g., aluminum hydroxide). Alum-precipitation functions as an
Adjuvant
, which enables the extract to elicit an immunological response. In addition, the alum-allergen complex produces a depot effect, where the allergen is more slowly released into the body. This slow release… read moreEffect of Formulation on Stability
Effect of Formulation on Stability Below is a figure that shows how expiration dating varies by formulation. For standardized products, these dates were established through FDA-approved testing methods. For non-standardized products, these dates were established by the FDA. For more information on extract formulation, please see the section on Extract Formulations Expiration dates for bulk…
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Formulation Concern – Alum
Formulation Concern – Alum Does aluminum (alum) have a negative impact on patient health? Aluminum has been used as an
Adjuvant
in numerous vaccines for over 70 years with no severe adverse effects reported. Despite suggestions, made decades ago, that alum may contribute to conditions such as Alzheimer’s disease or other neurological disorders, there has… read moreExtract Formulations
Extract Formulations Allergen extracts are available in a variety of formulations. An extract’s formulation directly impacts the stability of the allergenic proteins in solution and therefore the shelf life of the product. The FDA has determined maximum expiration dates for each formulation based on the estimated loss of potency over time. All extracts can be…
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