Evaluation of the design, development, and performance of a mass-flow based, open-source buffer manufacturing system

Natraj Ram; Jeff Johnson; Hiren Ardeshna; Joseph Camire; Ryan Campbell; Doan Chau; Sam Gardner; Kevin Gibson; Joey Norikane; Paul Randolph; Kelly Smith; Katherine Stafford; Rachel Swamy; Shana Usery; Kelvin H. Lee

doi:10.5731/pdajpst.2021.012660

Abstract

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.

Received June 22, 2021.
Accepted July 29, 2022.

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