​​NIIMBL-BioPhorum Buffer Stock Blending (BSB) System​

biophorum member logos niimbl logo with text 08
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).

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 recepticle 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

The presentation is available for download below.

The presentation is available for download below.

“Its speed is a gamechanger.”

Jeff Johnson, Engineering Lead

Key contributors to Buffer Stock Blending System build and test 2019-2021. These companies contributed financially or in kind:

These companies provided expertise:

(1)This work was performed under a Project Award Agreement from the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and financial assistance award 70NANB17H002 from the U.S. Department of Commerce, National Institute of Standards and Technology.