USP39<1207>

PACKAGE INTEGRITY EVALUATION—STERILE PRODUCTS

Aseptic Processing of Biological Products: Current Regulatory Issues “Facing the Challenges of Drug Product Manufacturing”

Aseptic Processing of Biological Products: Current Regulatory Issues “Facing the Challenges of Drug Product Manufacturing”

USP Overview and Some Current Activities

USP Overview and Some Current Activities
Anthony DeStefano, Ph.D. Senior Vice President, Compendial Science, USP

Selection of Containers/Closures for Use in Lyophilization Applications: Possibilities and Limitations

Abstract
The unit operation of freeze-drying is commonly employed in the pharmaceutical industry to enhance the storage stability of relatively fragile biopharmaceuticals. Yet without a suitable container closure system, the advantages of freeze-drying a biopharmaceutical product cannot be fully realized and appreciated. Primary packaging provides the first line of defense for all pharmaceutical products by maintaining the critical quality attributes (CQAs) throughout the product shelf life. Although primary packaging components are intended to provide a stable environment for the pharmaceutical products, without proper understanding they can affect the product adversely by adsorption, absorption, leaching and permeation. For biologic products, proper selection of container and closure (c/c) components is even more important as they are more sensitive compared to other small molecule pharmaceuticals. Additionally, c/c also impacts the lyophilization process development and ultimately the drug product characteristics. The composition and processing history of the packaging components can play significant role as the impurities and residuals can induce destabilization and alter the drug product characteristics. It is critical, therefore, to understand and address all of these concerns related to c/c selection for successfully developing a stable biologic product to avoid potential product incompatibilities.

Container Closure Integrity Testing Method Development and Validation for Prefilled Syringes

"In order to function both as a container closure system and as a drug delivery device, prefilled syringes feature many unique design elements.”