​​NIIMBL-BioPhorum Buffer Stock Blending (BSB) System​
Overview
A cross-functional team, assembled as part of the BioPhorum Technology Roadmapping initiative, has designed and built a full-scale cGMP buffer stock blending system in collaboration with the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)(1).
Buffer solutions are critical inputs to the manufacturing processes of therapeutic proteins and other biomolecules. Increasing titers, the addition of capacity to existing facilities and the intensification of bioprocesses have increased volumetric demand for buffers and created operational bottlenecks.
A cross-functional team, assembled as part of the BioPhorum Technology Roadmapping initiative, has designed and built a full-scale cGMP buffer stock blending system in collaboration with the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)(1).
The design documentation and performance data for the buffer stock blending (BSB) system has been made available open-source under a freedom to operate agreement, and can be downloaded below, to enable manufacturers to deliver buffer on-demand on a commercial scale at significant cost savings in labour and cost per litre compared to traditional buffer preparation methods.
This technology will significantly reduce the capital and operating costs of biopharmaceutical facilities in the future. The BSB System can equal four, five, six buffer preparation tanks with just one skid.
Problem statement
- Increasing titers
- Added capacity to existing facilities
- Intensification of bioprocesses
- Increased volumetric demand for buffers
- Operational bottlenecks
Build
- 4 stock solution pumps (2 high flow/ 2 low)
- Mass-flow receptacle based control
- Sized for 2kL SUB: 0.6m – 1.2m chromo columns
- Fully GMP design
- Connect to bags, tanks or directly to chromo skid
- PLC control with standard interface to DCS
Performance
- 2000-liter buffer is an eight-hour, one-shift operation
- BSB System made the entire buffer in an hour. 60 liters a minute, 2000 liters of buffer takes 40-50 minutes of a shift
Benefits
- Saves time
- Reduced footprint
- Reduced infrastructure
- Reduced labor footprint
- Enables real-time manufacturing
Resources
BSB System Design
Contact us to discuss your implementation with the design team, or to submit a case study
Advanced concept for buffer manufacturing
Initial concept publications
Published papers describing the project, drivers, concept and economic model
Automation
Bills of materials
Executed SAT
Functional Specification
I/O list
System P&ID
Test Protocol FAT
Presentations
Evaluation of the design
Design, development, and performance of a mass-flow based, open-source buffer manufacturing system
BPI Europe May 2022 BSB presentation
NIIMBL-BioPhorum Buffer stock blending system: vision, collaboration, design and outcome
ISPE virtual seminar NIIMBL
BioPhorum Buffer Stock Blending System presentation
IChemE global awards 2021 NIIMBL
BioPhorum Buffer Stock Blending System presentation
“Its speed is a gamechanger.”
Taken as the NIIMBL-BioPhorum Buffer Stock Blending System arrived at the University of Delaware Building in Newark, Delaware. It had shipped from IPEC in Wisconsin and marked the move from the Build Phase to the Test Phase of the project.
These companies provided expertise:
