This paper published in the PDA Journal describes a full scale, current Good Manufacturing Practices (cGMP) capable buffer stock blending system that has an open-source, configurable design and that overcomes the challenges of traditional buffer preparation.
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.
NIIMBL-BioPhorum Buffer stock blending system: vision, collaboration, design and outcome On behalf of the NIIMBL-BioPhorum BSB System Team Presented by: Jeff Johnson – Biotech Design, LLC Biotechdesignllc.com BPI Europe – 18 May 2022
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.
This presentation given by Kevin Gibson, Doan Chao and Paul Randolph on behalf of the team at a webinar for the Biochemical Engineering Award at the 2021 IChemE 2021 global awards. The project achieved highly commended in the category. It describes the work on the team on the NIIMBL BioPhorum buffer stock blending system.
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.
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.