Lyophilization process development for PanChol

We created a single-dose oral live-attenuated cholera vaccine (PanChol) that has the potential to circumvent the limitations of current killed vaccines. The Wellcome Trust funded a Phase I first-in-human study to evaluate the safety and immunogenicity of PanChol in healthy volunteers in Massachusetts, USA. This study was carried out using GMP-manufactured frozen PanChol cells. The results of this study are extremely promising. No dose-limiting side effects were observed and all volunteers, regardless of dose, developed robust vibriocidal antibody responses. Given the encouraging results in this trial, further development of PanChol is warranted. Our overarching goal in PanChol development is to enable real-world deployment of this vaccine in LMIC. A key next step to meet our goal is to create a new formulation of PanChol that will be feasible for storage and distribution in LMIC and that can be manufactured at scale at low cost. Here, we propose to develop a manufacturing process for a lyophilized presentation of PanChol. The key deliverable of the work is development and process engineering of a lyophilized form of PanChol stable at 2-8° for >2 years. The proposed process development is part of the critical path for developing a globally scalable product.