NIIMBL buffer stock blending system

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

This Addendum signals the release of the design and dataset from the performance testing of the NIIMBL BioPhorum buffer stock blending (BSB) system. 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.

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ISPE virtual seminar NIIMBL-BioPhorum Buffer Stock Blending System presentation

This presentation, presented to ISPE Young Professionals, provides an overview of the NIIMBL BioPhorum buffer stock blending system. This will be capable of supplying, in an automated manner, all buffers required for typical purification processes at a quality that is acceptable and equivalent to traditional batch buffer preparation. He  also gives an insight into the economic benefits of the technology adoption for both intermediate and large scale manufacturing facilities.

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Buffer Stock Blending (BSB) System: Published papers describing the project, drivers, concept and economic model

Buffers are critical inputs into all downstream processing steps associated with the manufacture of therapeutic proteins. The large volumes of buffer required present ongoing logistical challenges and account for a significant portion of a facility’s footprint, labor requirements and equipment costs. To address these challenges a collaboration of leading biopharmaceutical companies, engineering firms and suppliers has been working together to develop a design for a Buffer Stock Blending (BSB) System to support the preparation of buffers in-line and on demand from concentrated single-component stock solutions. These papers, in the first instance describe the project and activities up to the award of the contract to IPEC, the industry drivers for change and the novel approach to buffer preparation, and in the second paper deep-dive into some of the modeling work done to establish the economics and benefits of the approach.

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Biomanufacturing technology roadmap: 3. Process technologies

This chapter of the first edition biomanufacturing technology roadmap published in 2017, describes the vision, scope and benefits that could be gained in the biopharmaceutical manufacturing industry from the development and adoption of effective process technologies. To help the industry achieve this future state it describes the scenarios considered, the future needs, challenges and potential solutions as well as the linkages and dependencies on other parts of the roadmap. It considers the contribution that disruptive and emerging technologies can play and regulatory considerations before finalizing with conclusions and recommendations.

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