Enabling adoption – collaboration delivers fully tested proof of concept design and dataset for NIIMBL-BioPhorum Buffer Stock Blending System

NIIMBL-BioPhorum Buffer Stock Blending System

BioPhorum is pleased to share for the first time the full design and dataset from a Proof-of-Concept which has performed beyond expectations, marking a step change in the biomanufacturing industry’s approach to buffer stock preparation.

The publication of the Addendum to the White Paper (2019) alongside a technical article accepted by the PDA, Evaluation of the design, development, and performance of a simplified modular, mass-flow based, on-demand open-sourced buffer manufacturing system means that the long wait for the output from this three-year undertaking is finally over. For the BioPhorum team, it does not end here – to accelerate the adoption of this innovative system, the design and testing dataset is available open source on BioPhorum.com to allow you and your organization to download the data, and test and implement the system. The team is keen to interact with those looking to apply the Buffer Stock Blending System, answer questions, share their experiences, and track implementation.

Through our Proof-of-Concept Program, BioPhorum is committed to democratizing the availability of technology and lowering barriers to adoption by the biopharmaceutical industry – follow this link to access the design and dataset and other material relating to the collaboration, including a short film showing the impact the performance testing had on some of our members.

Objective
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 that reduce 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 Buffer Stock Blending (BSB) System. This has enabled the BioPhorum team to demonstrate the performance of its recipe-based approach to support on-demand automated buffer delivery for biopharmaceutical processes through precise buffer stock solution blending using mass flow control.

The design process was first documented in 2019 in the NIIMBL-BioPhorum Buffer Stock Blending System: A More Advanced Concept for Buffer Manufacturing and An Economic Evaluation of Buffer Preparation Philosophies for the Biopharmaceuticals Industry papers, which can be found on the BioPhorum website.

Construction of the system was completed in 2020 and the skid itself moved from a vendor in Wisconsin to NIIMBL Headquarters in the new University of Delaware building in Newark. Notwithstanding restrictions imposed during the pandemic in 2020, members of the team located on the East Coast of the US executed the Realization Protocol and then performed a Demonstration (range-finding) Study which has been documented in an article accepted for publication by the PDA, evaluating the learnings and outputs of the test phase.

White Paper Addendum
The Addendum contains information relating to the methods and approach, the testing performed, an analysis of the results, and the lessons learned intending this knowledge base, alongside the PDA article and datasets on the BioPhorum website, to reduce barriers to adoption of this new approach and reducing lead times to implementation. This proof of concept is the first of BioPhorum’s targeted efforts to encourage the adoption of new technologies and processes into the industry; further proof of concept initiatives has been initiated by BioPhorum members who want to leverage the value of collaboration to accelerate robust industry consensus solutions to adoption.

The Addendum describes how a team of biomanufacturers, supply partners and engineering partners with funding from NIIMBL and its own contributions in kind, collaborated on the design and completed performance testing that has demonstrated that the system can produce buffer with ‘game changing’ speed and efficiency. Through online and offline testing, the buffer created met the accuracy requirements of the biomanufacturing industry, at speed. The system was also successfully connected to a chromatography skid to demonstrate how the system supports on-demand buffer delivery to a downstream process. In addition to a full account of the project, the Addendum also contains a comprehensive appendix including online pH and conductivity data from the range-finding study and a list of acronyms used in the document.

Performance Tested
The design and dataset documentation including the piping and instrumentation diagram (PID), Test Protocol and comprehensive data and analysis supports the team’s conclusions that the design, which was tested with four different pumps, provides a flexible solution. This has the potential to reduce cleanroom footprint, and labor, and with ‘game-changing’ speed reduce the planning cycle for manufacturing, eliminating the need for large buffer prep and hold areas and reducing the overall facility footprint for buffer preparation. The system is a significantly faster approach to the production of buffer on-demand and as a result, is expected to reduce operating expenditure.

Members of the team are excited by the potential to produce enough buffer to feed six bioreactors with a single skid, instead of one tank one shift, and believe the NIIMBL-BioPhorum Buffer Stock Blending (BSB) System shows significant potential to reshape existing and future biomanufacturing facilities.

Publicity
The wait to release the documentation open source has meant that conference presentations were focused on the collaboration and the URS/early design.
To raise the profile of the BSB System, the team agreed on a ‘soft’ launch with Rockwell Automation at the Interphex 2021 trade show in October. The BSB System was shipped to the site and exhibited on the Rockwell Automation stand. Team members from Rockwell, Lonza, and NIIMBL attended and presented the results of the collaboration to delegates, which was well received.

Carrie Mason, Associate Director at Lonza Biologics, said the opportunity to present the BSB System at Interphex was highly positive. “Physically displaying the skid was a win, as many comments were around how compact the skid footprint was while delivering such high output. The attention to detail and design skills of the team really were evident as the skid proved extremely easy to demonstrate how user-friendly it is, from the control panel to the locations of the connections. Interphex enabled showcasing that the BSB System is a reality that can be implemented today in facilities, which is a win for all involved.”

“There was much interest from visitors on what the BSB system was, how it helped overcome an industry challenge, and the amazing collaboration it took to achieve it,” said Doan Chau, Global Life Sciences Industry Consultant at Rockwell Automation. “Many people were impressed by how much faster the system could produce buffers, as compared to traditional ways of manufacturing them.”

Doan Chau also observed, “Many vendors were also very impressed with the collaboration and were really interested in how they could become a part of similar initiatives in the future. It means a lot for Rockwell to be a part of a workstream and project that will ‘revolutionize’ how buffers are made in both large- and small-scale drug manufacturing.”

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