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.
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“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.