Critical Needs and Opportunities for Advanced Manufacturing of Lyophilized Injectables.

Lyophilized drugs and biologics have an outsized role in protecting public health due to their ability to provide extended shelf life for stockpiling. Over 70% (14 out of 19) of antibiotics on the Essential Medicines list are supplied as lyophilized sterile powders for injection (FDA, 1). Additionally, many new drugs, including first-in-kind medicines, such as the first checkpoint inhibitor cancer immunotherapy Keytruda, were initially introduced to market in a lyophilized form, accelerating availability to patients by several years while a stable liquid formulation was being developed. The article describes methodologies, both short-term and long-term, to address the current manufacturing challenges for lyophilized injectables based on the findings of the workshop by National Institute of Pharmaceutical Technology and Education held in January 2024.