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Evaluation of the Design, Development, and Performance of a Mass-Flow Based, Open-Source Buffer Manufacturing System
Natraj Ram1, Jeff Johnson2, Hiren Ardeshna3
1Thermo Fisher Scientific.
PDA Journal of Pharmaceutical Science and Technology
|August 20, 2022
Summary
A novel buffer blending system streamlines biomanufacturing by preparing solutions on-demand, overcoming traditional inefficiencies. This cGMP-capable system uses mass flow control for cost-effective, high-quality therapeutic protein production.
Area of Science:
- Biotechnology
- Biopharmaceutical Manufacturing
- Process Engineering
Background:
- Buffer solutions are essential for therapeutic protein and biomolecule manufacturing.
- Traditional buffer preparation methods are resource-intensive and create operational bottlenecks.
Purpose of the Study:
- To describe a novel, full-scale buffer stock blending system.
- To demonstrate a system that overcomes traditional buffer preparation challenges.
Main Methods:
- Implementation of a current Good Manufacturing Practices (cGMP) capable system.
- Utilizing an open-source, configurable design with mass flow control for on-demand buffer supply.
- Incorporating self-cleaning capabilities and amenability to closed-system operation.
Main Results:
- The system provides simplified control and operation.
- On-demand supply of buffer solutions is achieved.
- Demonstrated excellent performance and capabilities for biomanufacturing.
Conclusions:
- The described buffer blending system offers a transformative impact on biomanufacturing.
- The system enhances efficiency and reduces costs compared to traditional methods.
- The open-source design allows for broad applicability and customization.
