Allergenic Materials to Produce Extracts – Natural or Recombinant Allergens

Allergenic materials are used to prepare allergen extracts to diagnose and treat allergic patients. Natural allergenic materials have been used for this purpose for many years. 

It is often difficult to obtain enough sufficient quantities of natural allergenic materials. In addition, the safety of those allergenic materials is questioned, particularly in Europe, where medical regulatory agencies have proposed guidelines to monitor the quality of these products.

A different perspective regarding natural allergenic materials exists in the United States of America (USA). Currently, the Food and Drug Administration in the USA only demands that the quality and safety of the final allergenic extracts be assessed. This organization has not yet focused on assessing the quality of the allergenic materials used to prepare the associated extracts.

Recombinant allergens are alternatives to circumvent the caveats of using natural allergenic materials. While the science of obtaining recombinant allergens is rapidly evolving, natural products most likely will continue to be used for many years to come because of the varying limitations regarding the production and use of recombinant allergens.  For example, it is currently not possible to obtain recombinant forms of all clinically relevant allergens. In addition, the safety and efficacy of such allergens need to be properly documented through appropriate clinical trials, which takes time to complete and is extremely expensive.

We are in a transition period.  Meanwhile, the perspectives regarding the use of natural allergenic materials to prepare allergenic extracts in the USA and Europe should be harmonized.

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