During manufacture, the quality control (QC) of allergenic extracts presents a variety of challenges. One important consideration is the expected variability that is inherent with naturally derived source materials. Allergenic 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. ALK has defined four quality parameters that should be monitored throughout the manufacturing process. These include:
We believe that these are the attributes that most significantly impact the product’s performance in the clinic.
A ‘well-characterized’ approach to an extract quality assessment would require that all four parameters be evaluated. An effective quality monitoring program would then provide additional information to the Allergy Specialist to support allergy diagnosis and treatment decisions. ALK is pursuing this well-characterized approach for a number of extracts and data are available to allergy clinics upon request.
To learn more about ALK's quality parameters, please review our Commitment to Quality.