Buffer Stock Blending
The Problem
Traditional methods for preparing biopharmaceutical buffers require significant capital cost, floor space and time, often resulting in production bottlenecks. IPEC was invited to assist a consortium led by NIIMBL and BioPhorum with the design and fabrication of a new platform used to evaluate the effectiveness of on-demand buffer production.
The Solution
The system realized through consortium efforts delivers on-demand buffers using common stock concentrates through in-line dilution, eliminating the need for large centralized buffer preparation facilities. The system is flexible and scalable, making it ideal for use in a variety of settings. A subsequent validation study concluded that BSB meets or exceeds the initial goals for acceptability in cGMP manufacturing.
Innovation+
While the data and design resulting from the initial NIIMBL-BioPhorum study are open-source, IPEC has since incorporated many design improvements into a next-generation platform.
© Integrated Process Engineers & Constructors, Inc. All rights reserved.
1901 Allen Drive
Fort Atkinson, WI 53538 USA
NIIMBL-BioPhorum Study *
▪︎ Up to 150X dilution possible (dependent on stock concentrations)
▪︎ Time of start-up/balancing to dispense of 15-45 seconds
▪︎ Low stock concentrate waste of (<5% @200L batch, <1% @3000L)
▪︎ Greater than 99% compositional accuracy possible (dependent on volume dispensed)
▪︎ Downtime < 2 minutes between product changeover
▪︎ Significant decrease in both CAPEX & OPEX possible
* See links to articles, etc. in the Resources Section below
IPEC - Next-Gen BSB System
▪︎ Reduced system footprint/hold-up volume
▪︎ Line size modifications for improved system hydraulics
▪︎ Increased maximum system flow rate/capacity
▪︎ Updated concentrate feed line flushing design
▪︎ Pump speed control & feedback improvements
▪︎ Additional dispensing outlet
▪︎ Installation sensors/safety interlocks on CIP Jumpers
▪︎ Increased system pressure rating and improved pump overpressure protection
IPEC - Next-Gen BSB System
▪︎ Up to 80 lpm pump WFI for dilution
▪︎ (3) concentrate supply pumps up to 20 lpm each
▪︎ Digital communications for process-critical instrumentation and components
▪︎ Mass balance/flow-based dilution
▪︎ Improved automation/recipe management platform
▪︎ Hybrid 316L SS/Hastelloy-C wetted construction
▪︎ Self-CIP
▪︎ 21 CFR Part 11 compliance
IPEC - Next-Gen BSB System
▪︎ WFI Break Tank
▪︎ Low-flow inlet (3 lpm) for more dilute solutions or higher concentration stocks
▪︎ Additional inlet pumps
▪︎ Additional inlet ports
▪︎ Additional outlet ports
▪︎ Additional valving and instrumentation to support full chromatography proccess
▪︎ Other general customizations available