BRIEFING

 〈1049.1〉 Design of Stability Studies for Biotechnological and Biological Product Development and Life Cycle Management. This proposed new general chapter, a companion to Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products 〈1049〉, provides details regarding the overall stability strategy and life cycle management of biotechnological and biological products, as well as the design of stability studies through all stages of the product life cycle. This general chapter focuses on the complexity of formal stability studies designed to support the expiration period and storage conditions, as well as other studies that build knowledge of the product stability necessary for product characterization, transportation and handling, and patient and physician use.

 (BIO2: J. Zhang)

 Case ID—SUB-2014