Managing buffers in bioprocessing remains a largely manual process, requiring space and resources and often creating bottlenecks that increase costs and decrease efficiency. Researchers from many of the leading big pharma and pharma technology developers tackled those issues by creating a new configurable, open-source, current Good Manufacturing Practices (cGMP)-capable buffer stock blending (BSB) system.
Dubbed the NIIMBL-BioPhorum Buffer Stock Blending Skid, it uses continuous buffer preparation methods (notably, mass flow controls) to produce a wide range of buffers on demand from a few common buffer solutions. With a self-cleaning capability, it can operate as a closed system and can be used for continuous, intensified, or traditional fed batch processes. Details are outlined in a paper in the PDA Journal of Pharmaceutical Science and Technology.
“By accelerating the speed by which buffers can be made, the technology can streamline and improve operations, and by (employing) stock solutions, the technology can simplify the process and lead to more resilient supply chains,” corresponding author Kelvin H. Lee, PhD, director, Manufacturing USA National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), University of Delaware, tells GEN.
“It also can lead to significantly reduced facility footprints, which will reduce the cost to build new facilities as well as facilities’ environmental impacts,” he says, and enable increased use of single-use technology, thus reducing processing-based energy demands.
Potentially significant operational savings
This BSB skid can produce 4,000L of buffer in two hours, compared to the six to eight hours needed for traditional buffer preparation and can supply buffers for a 6 x 2000-L single-use monoclonal antibody facility at titers of approximately 5 g/L. Composition accuracy exceeds 98%. Potentially significant operational savings accrue from preparing fewer individual solutions and using fewer consumables, thus requiring fewer personnel.
In-line buffer control hasn’t been widely used to date because of the high initial cost of designing systems for existing facilities and the general lack of experience in this area. This BSB skid, therefore, “represents a step change for the industry,” the authors of the PDA Journal paper wrote, driving improvements in buffer flexibility, speed, cost, and quality.
To implement this system in their own facilities, organizations can access the publicly-available design documents and either fabricate skids directory or make adjustments to suit their own specific needs, Lee says, adding that. “A goal… is to keep barriers to adoption… as low as possible.”
