Immunotherapy Preparation Guidelines, Rules, and Regulation

Abstract

Allergen immunotherapy has been used to treat allergic diseases for more than 100 years. In the U.S., the preparation of diagnostic and therapeutic extracts requires the cooperation of the extract manufacturer, who provides the individual allergen concentrates, and the practicing physician who formulates, dilutes, and administers the final patient-specific treatment extract. The guidelines, rules, and regulations for these activities have been established and continue to be developed as progress is made. The molecular characterization and standardization of allergenic extracts has allowed for improvements in defining the potency of these products. In turn, these advances have led to improved dosing regimens and formulation practices. This review will describe in detail some of these interactions and will identify issues that require more attention.

Similar biological activity in skin prick test for Oralair® (8200 BAU) and Grazax® (6200 BAU) reinforces effective SLIT dosing level

“…It could very well be that the fast‐dissolving mechanism of the Grazax ® tablet compensates for the slightly lower allergen content, by producing a high trans‐mucosal concentration gradient. This is an interesting finding, as historically the medical community has always focused on the allergen content as being the sole variable that confers efficacy to immunotherapy, as is the case for SCIT . As such, for SCIT probable effective doses per allergen are suggested .…”

Evaluation of the manufacturer-dependent differences in specific immunoglobulin E results for indoor allergens

“…In the United States, the standardization of the extracts also focuses on their allergenic potency; however, the Food and Drug Administration (FDA) mandates the use of reference extracts to standardize several allergen sources. [19][20][21] Two exceptions are cat hair and ragweed pollen extracts, because these are standardized for the major allergens Fel d 1 and Amb a 1 in a radial immunodiffusion assay. This might be a step toward better comparability; however, standardization based on potency has its pitfalls, because it falls short of revealing any information about the relative allergen composition.…”

Comparison of the efficacy and safety of pollen allergen extracts using skin prick testing and serum specific IgE as references

“…The in-house extracts were prepared according to the international immunotherapy preparation guidelines rules and regulation advice on the formulation of allergenic extracts with international standards. 18 This is a step to further confirming research before entering the clinic. Our pollen allergen extracts used in this study were subsequently produced by Greater Pharma Company Limited, a GMP certified manufacturing company in Bangkok, Thailand.…”