During manufacture, the quality control (QC) of allergen extracts presents a variety of challenges. One important consideration is the expected variability that is inherent with naturally derived source materials. Allergen extracts exhibit a certain degree of lot-to-lot variability that cannot be avoided. However, if the extract manufacturing steps are well controlled this allows each supplier to deliver products that have a reasonable level of batch consistency.
At present, quality monitoring of extracts is primarily accomplished by characterizing the final product with various analytical methods.
An effective quality monitoring program provide additional information to the Allergy Specialist to support allergy diagnosis and treatment decisions. ALK is pursuing this well-characterized approach for several extracts, and data are available to allergy clinics upon request.
To learn more about ALK’s quality parameters, please review our Commitment to Quality.
For more information, see the following sections: