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 for addressing this bottleneck and led the Buffer Preparation Workstream to write a User Requirements Specification for a buffer preparation system.
Its vision was to design, build, test, and make available an ‘open source’ system, recognizing that democratizing the technology would be the best way to accelerate its uptake and the pace of change. Created with the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), the ‘open source’ nature of the design and dataset will also allow the evaluation of the technology without excessive costs.
The NIIMBL-BioPhorum BSB System can equal four, five, or six buffer preparation tanks with just one skid and its performance is a significant improvement on existing processes. For example, whereas producing a 2,000L buffer is currently a one-shift/eight-hour operation, the BSB System can make the entire buffer in 40–50 minutes. Not only will this save time and enable real-time manufacturing, but it will also reduce footprint, infrastructure and labor needs.
“Its speed is a gamechanger,” said Jeff Johnson, Engineering Lead at BioTech Design (formerly Merck & Co.).
The technical build is:
- Four stock solution pumps (two high flow/two low flow)
- Mass-flow receptacle-based control, sized for 2,000L (single-use bioreactor: 0.6m–1.2m chromo columns)
- Fully cGMP-compliant design
- Can connect to bags, tanks or directly to chromo skid
- Programmable logic controller control with a standard interface to distributed control system.
The collaboration between BioPhorum, NIIMBL, biomanufacturers, supply partners and engineering partners is subject to an embargo on sharing the design and dataset until the publication of the White paper addendum to the NIIMBL-BioPhorum Buffer Stock Blending System – a more advanced concept for buffer manufacturing, which will be published, alongside a separate article submitted for peer review, in 2022.
The Addendum identifies lessons learned and future improvements. It also offers insights into the potential for the BSB System to be used in scenarios such as continuous manufacture and plug-and-play, and its application in other processes requiring the preparation of liquids for biomanufacture.
While the embargo is in place, the team wanted to start raising the profile of the BSB System and the Interphex 2021 trade show in October was used as a ‘soft’ launch to industry. Carrie Mason, Senior Manager R&D at Lonza Biologics and Doan Chau, Global LS Industry Consultant at Rockwell Automation, delivered a presentation at Interphex 2021 that told the story of the design, build, test, and data analysis of the BSB System.
They shared the industry’s current challenges with buffer preparation (e.g., needing to respond to the increased productivity upstream and resulting increased titers) and described the impact of implementing the BSB System for different scenarios.
To support the launch, a resource page has been developed to bring together photographs, videos, publications and presentations until the full design and dataset are available. The site also contains the presentations from Interphex 2021 and IChemE Awards 2021, at which the BSB System was Highly Commended in the Biochemical Engineering Award category.
The BSB System is a technological advance that has the potential to transform industry. With its trailblazing approach to prototyping, leveraging relationships and using resources over three years, it is a real example of BioPhorum producing tangible outcomes and developing new ways of working with our members, delivering real change in the industry.