RT Journal Article
SR Electronic
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
FD Parenteral Drug Association (PDA)
SP 79
OP 98
DO 10.5731/pdajpst.2021.012660
VO 77
IS 2
A1 Ram, Natraj
A1 Johnson, Jeff
A1 Ardeshna, Hiren
A1 Camire, Joseph
A1 Campbell, Ryan
A1 Chau, Doan
A1 Gardner, Sam
A1 Gibson, Kevin
A1 Norikane, Joey
A1 Randolph, Paul
A1 Smith, Kelly
A1 Stafford, Katherine
A1 Swamy, Rachel
A1 Usery, Shana
A1 Lee, Kelvin H.
YR 2023
UL http://journal.pda.org/content/77/2/79.abstract
AB 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.