TY - JOUR T1 - Evaluation of the design, development, and performance of a mass-flow based, open-source buffer manufacturing system JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol DO - 10.5731/pdajpst.2021.012660 SP - pdajpst.2021.012660 AU - Natraj Ram AU - Jeff Johnson AU - Hiren Ardeshna AU - Joseph Camire AU - Ryan Campbell AU - Doan Chau AU - Sam Gardner AU - Kevin Gibson AU - Joey Norikane AU - Paul Randolph AU - Kelly Smith AU - Katherine Stafford AU - Rachel Swamy AU - Shana Usery AU - Kelvin H. Lee Y1 - 2022/01/01 UR - http://journal.pda.org/content/early/2022/08/19/pdajpst.2021.012660.abstract N2 - Buffer solutions are a critical component of the manufacturing process for therapeutic proteins and other biomolecules. The traditional way to make and use buffers is space and resource intensive, creating operational bottlenecks that impact efficiencies and costs. Here we describe a full scale, current Good Manufacturing Practices (cGMP) capable buffer stock blending system that has an open-source, configurable design and that overcomes the challenges of traditional buffer preparation. The system comprises simplified control and operation using mass flow to provide on-demand supply of buffer solutions. The system also has self-cleaning capability and is amenable to be operated as a closed system. The data will demonstrate the excellent performance and capabilities of the system as well as illustrate its potential transformative impact on biomanufacturing. ER -