HIGHLIGHTS ON THE CONTROL OF FREEZE-DRIED BIOLOGICALS WITH SPECIAL REFERENCE TO THE ROLE OF RESIDUAL MOISTURE

摘要

Freeze-dried vaccines and other freeze-dried biological products are regulated by the Center for Biologies Evaluation and Research (CBER) of the United States Food and Drug Administration (US FDA). Biological products are complicated in their manufacture. In addition to the submission of complete manufacturing, assay validation, and clinical study information for licensure, they are subject to lot release both at the time of licensure and after the product has been licensed. The regulations indicate testing for safety, sterility, identity, pyrogen, potency, constituent materials and residual moisture in the case of freeze-dried products. Lots are not distributed into interstate commerce until the lot has been released by CBER. The many types of test methods and bioassays involved vary in accuracy. Accuracy levels are discussed for freeze-dried biological products purity test methods including tests for residual moisture and constituent materials such as additives, adjuvants such as aluminum, and preservatives such as thimerosal, and phenol. Accuracy and assessment of error or uncertainty for residual moisture methods are presented.