White paper addendum to the NIIMBL-BioPhorum buffer stock blending system – a more advanced concept for buffer manufacturing

The preparation and storage of buffers and solutions during the manufacture of therapeutic proteins requires intensive equipment use, cleanroom footprint, labor and schedule time. This has a significant impact on the cost of manufacturing and can result in process and facility bottlenecks, reducing overall productivity.

To address this issue, BioPhorum’s Buffer Prep Workstream collaborated with the National Institute for Innovation in Biopharmaceutical Manufacturing (NIIMBL) to design and build a fully scaled, cGMP-ready system intended to deliver buffer on demand – a buffer stock blending (BSB) system.

In 2020, the system was constructed, installed and tested by a team of NIIMBL and BioPhorum members. The results of extensive testing demonstrate excellent performance and show significant potential to reshape existing and future biomanufacturing facilities.

This Addendum signals the release of the design and dataset from the performance testing. It is being made available as ‘open source’, which the team hopes will encourage industry adoption of the BSB System.

The paper provides the team’s evaluation of the testing outcomes. It also contains information relating to the methods and approach, and the lessons learned so that others can develop and improve this technology by understanding its benefits and applications.

This technology will significantly reduce the capital and operating costs of biopharmaceutical facilities in the future. Making the design available as open source is the first step in democratizing it for the industry.

To find out more about the project see the Buffer stock blending system resource page

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• File Size 4.28 MB
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• Create Date 19th August 2022
• DOI https://doi.org/10.46220/2022TR006
• Last Updated