NEWARK, Del., October 18, 2022 — The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) in collaboration with BioPhorum is pleased to announce that the data and design specification for the NIIMBL BioPhorum Buffer Stock Blending System are now publicly available for open-source use. This new current good manufacturing practices (cGMP) buffer technology is designed, built, and tested to deliver buffer on-demand on a commercial at significant cost savings in labor and cost per liter compared to traditional buffer preparation.
Buffer solutions are critical to the downstream manufacturing processes of therapeutic proteins and other biomolecules. These solutions constitute the largest proportion by volume of a bioprocessing run and contribute to significant costs in facility footprint, labor, and capital.
“NIIMBL’s goal is to seek to accelerate adoption of this new buffer technology and the team has demonstrated the proof of concept as documented in our recent PDA Journal of Pharmaceutical Science and Technology publication; thus, we are able publicly share the data and design of the buffer skid and are that much closer to seeing commercial adoption,” said Kelvin H. Lee, NIIMBL institute director. “We invested in bringing a solution to an industry need that will dramatically alter the way buffers are prepared in the biopharmaceutical manufacturing industry,” adds Lee.
Tim Hawkins, BioPhorum CEO explains “Having realized that buffer blending was becoming a bottleneck for modern biomanufacturing facilities, the BioPhorum team rapidly established a concept design that would be low cost, flexible, and reduce facility footprint. BioPhorum was delighted to partner with NIIMBL, which funded and led the fabrication and testing in its facility.” Hawkins adds, “By freely sharing this data we intend to help drive global industry-wide change of this transformational technology and look forward to seeing biomanufacturers across the world enjoy the substantial benefits that will flow as a result.”
NIIMBL led a core team of engineers from industry through a period of two years during the pandemic to optimize the initial design and conduct all the testing and data analysis at the NIIMBL headquarters. This project brought together a diverse team of experts from NIIMBL and BioPhorum member communities including Asahi Kasei Bioprocess, Avantor, Biogen, Biotech Design LLC, Cytiva, GSK, Janssen, Lonza, Merck, MilliporeSigma, Pall Corporation, PM Group, Rockwell Automation, Sanofi, Takeda, and Thermo Fisher Scientific.
GSK Leader and a technical partner to the buffer skid, Hiren D. Ardeshna shared, “the NIIMBL BioPhorum Buffer Stock Blending System leads the way in simplifying solution management by using single component stock solution to deliver the required industry buffers at a very high rate. This technology has the ability to reduce labor and plant time by completely outsourcing the stock solution preparation and eliminating the need for any buffer infrastructure; saving significant cost and capital,”
The NIIMBL BioPhorum Buffer Stock Blending System prototype model is currently located at the NIIMBL headquarters in Newark, Delaware. To learn more about NIIMBL and the NIIMBL BioPhorum Buffer Stock Blending System visit NIIMBL.org and to access more information about the design of the buffer visit BioPhorum.
The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is a public-private partnership whose mission is to accelerate biopharmaceutical innovation, support the development of standards that enable more efficient and rapid manufacturing capabilities, and educate and train a world-leading biopharmaceutical manufacturing workforce, fundamentally advancing U.S. competitiveness in this industry. NIIMBL is part of Manufacturing USA®, a diverse network of federally sponsored manufacturing innovation institutes, and is funded through a cooperative agreement with the National Institute of Standards and Technology (NIST) in the U.S. Department of Commerce with significant additional support from its members.
BioPhorum’s mission is to create environments where the global biopharmaceutical and device industry can collaborate and accelerate its rate of progress, for the benefit of all. Since its inception in 2004, BioPhorum has become the open and trusted environment where senior leaders of the biopharmaceutical industry come together to openly share and discuss the emerging trends and challenges facing their industry. Growing from an end-user group in 2008, BioPhorum now comprises over 135 manufacturers and suppliers deploying their top 6,000 leaders and subject matter experts to work in ten focused Phorums, articulating the industry’s technology roadmap, defining the supply partner practices of the future, and developing and adopting best practices in drug substance, fill finish, process development and manufacturing IT. In each of these Phorums, BioPhorum facilitators bring leaders together to create future visions, mobilize teams of experts on the opportunities, create partnerships that enable change and provide the quickest route to implementation, so that the industry shares, learns and builds the best solutions together.
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