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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BioPhorum members have built a Buffer Stock Blending (BSB) System that will change the way buffer preparation is performed across the industry and significantly reduce the capital and operating costs of biopharmaceutical facilities in the future. Traditional buffer preparation requires substantial amounts of labor, capital, footprint, and time. The first edition of BioPhorum’s Biomanufacturing Technology Roadmap identified the potential...
The biopharmaceutical industry is no stranger to making strategic alliances to drive progress throughout all stages of a product’s lifecycle. The same can be said of BioPhorum and partnering is core to what we do through our ground-breaking approach to collaboration. Building on this success, we have been finding ways to expand our reach in technical development and identify partners to provide facilities and ‘test-bed environments’. So, to...
Buffer Stock Blending (BSB) System: Published papers describing the project, drivers, concept and economic model
Nov 2019 | Technology Roadmapping
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.
NIIMBL Roadmaps: 1. Vaccines: 2. Antibody-Drug Conjugates (ADC) and Bi-specific Antibodies: 3. Gene Therapies
The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) collaborated with BioPhorum to create and publish three technology roadmaps covering Vaccines, Gene Therapy and Antibody-Drug Conjugates/ Bispecific antibodies. Developed using the highly successful roadmapping process that led to the first edition of the BioPhorum Biomanufacturing Technology Roadmap. These documents compliment the original Technology Roadmap and detail the manufacturing challenges, technology needs and areas of opportunity in each of the three product categories with additional focus on US regulatory and workforce challenges.