Full data set for new buffer stock blending system freely available

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and BioPhorum have announced that the data and design specification for a novel Buffer Stock Blending System are now a publicly available open-source resource.

The new current good manufacturing practices (cGMP) buffer technology is designed to deliver buffer on-demand commercially to save labour costs and cost per litre compared to traditional buffer preparation.

Buffer solutions are vital for the downstream manufacturing of therapeutic proteins and other biomolecules. However, they take up a large portion of bioprocessing production. To solve this challenge, Hiren D. Ardeshna, GSK Leader and technical partner to the buffer skid stated, “this technology…completely outsources the stock solution preparation and eliminates the need for any buffer infrastructure; saving significant cost and capital.”

Ardeshna shared, “the new 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.”

“NIIMBL’s goal is to accelerate adoption of this new buffer technology. 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 we are much closer to seeing commercial adoption,” commented Kelvin H. Lee, NIIMBL Institute Director. He added that the innovative process will “…dramatically alter the way buffers are prepared in the biopharmaceutical manufacturing industry.”

Tim Hawkins, CEO of BioPhorum acknowledged: “Having realised 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.”

“By freely sharing this data we intend to help drive global industry-wide change of this transformational technology,” explained Hawkins.

NIIMBL funded and led fabrication and testing of the technology in BioPhorum’s facility. Over a period of two years, a core team of NIIMBL engineers optimised the initial design and conducted all the testing and data analysis.

Companies involved in development of the technology were 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.