Environmental sustainability assessment as a driver for selection of the manufacturing processes of a bispecific T-cell engager

A focus on environmental sustainability is important in selection of our commercial drug substance manufacturing processes. During clinical development of a bispecific T-cell engager (BITE) molecule we developed two processes to manufacture this important biologic: (1) a stirred tank process and (2) a continuous manufacturing process. We will describe the challenges and opportunities of developing and producing this novel biologic modality, while also minimizing the environmental impact. We will highlight the metrics and methods used to measure and improve the environmental performance of the processes, such as carbon emissions, water consumption, waste generation, and energy efficiency. The benefits of adopting a life-cycle management approach and leveraging continuous manufacturing technologies to enhance the sustainability of the process during development will be discussed and the results compared to the stir tank process to enable the identification of the optimal process for manufacturing of this innovative BITE molecule.