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Buffer Stock Blending System

The full-scale, open-source prototype Buffer Stock Blending (BSB) System will potentially significantly reduce capital investment and manual operation costs, reduce the number and volume of buffer, and decrease time for buffer manufacturing.
Categories
Drug substance
Equipment and Supplies
Project status
100% Completed

Solution

Buffer solutions are a critical piece of the manufacturing process of therapeutic proteins and other biomolecules. The traditional way to make and use buffers is space- and resource-intensive, creating operational bottlenecks that impact efficiencies and costs.

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.

The full-scale, prototype Buffer Stock Blending (BSB) System will potentially significantly reduce capital investment and manual operation costs, reduce the number and volume of buffer, and decrease time for buffer manufacturing. The open-source model provides a flexible solution using mass flow control for small batch process to provide an on-demand supply of buffer solutions directly to the biomanufacturing process. 

Outcomes and Impacts

A relatively small number of standard stock solutions can be used to produce a wide range of commonly used buffers in biomanufacturing.

Reduction in the volume of solution that is handled on a per batch basis. In addition, the use of single component stock solutions offers the ability to maximize the concentration factor of stored solutions.

The system is designed to be directly connected to process equipment such as a chromatography column or filtration system with out of specification buffers directed to waste.

The system is also designed to be GMP/GAMP 5 compliant and able to support use in a non-cleanroom environment with CIP for all process contact surfaces.

Updates, Related Publications, and Deliverables

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Project Lead

NIIMBL

NIIMBL

Participating Organizations

Cytiva

Cytiva

GlaxoSmithKline, LLC

GlaxoSmithKline, LLC

Janssen Research & Development, LLC

Janssen Research & Development, LLC

Merck Sharp & Dohme LLC

Merck Sharp & Dohme LLC

MilliporeSigma/EMD Serono

MilliporeSigma/EMD Serono

Sanofi

Sanofi

Takeda Pharmaceuticals

Takeda Pharmaceuticals