Process Scale-Up and Optimization of Lyophilized Vaccine Products

摘要: Vaccine, in general, is our best defense against infectious diseases and represents one of the greatest success stories responsible for reduction diseases. Relative to therapeutic proteins (TPs) small molecules, vaccine drug product development more challenging it often stated that “process product” especially live virus vaccines (LVVs). Given global outreach corresponding impact on human health, a well-defined systematic approach must be used achieve target profile (GTPP) not only safe efficacious but also delivers intended market demands while keeping customer centricity mind (e.g., thermostability, delivery devices/images, etc.). This chapter intends share findings attaining GTPP lyophilized products by sharing commonly guidelines approaches quality design (QbD), process analytical testing (PAT), experiment (DOE), etc.) end-to-end (from preformulation commercialization). Specifically, technical aspects laboratory scale lyophilization scale-up challenges are described as they pertain various manufacturing unit operation good practice (GMP), quality, operations systems within each environment. In addition, suitable case studies demonstrating (a) loading commercial cabinet (b) equipment/facility considerations during transfer/scale-up products’ critical attributes (CQAs) discussed.