Inline Buffer Dilution: An Agile System For Downstream Processes

Inline buffer dilution is a method for on demand buffer preparation at the point of use. It has been subject to optimization and automation for decades and is increasingly used in single-use systems, in upstream, downstream and fill & finish processing steps in all kind of biopharmaceutical processes such as chromatography and filtration steps of e.g. monoclonal antibody or other biologics.

Virtually all processing steps (unit operations) during the manufacturing of biologics and other substances in the pharmaceutical industry require buffer solutions to ensure the dissolution or precipitation and stability of the respective product and impurities. In addition, the properties of the solution, such as titers, pH value, osmolarity, conductivity, etc. are crucial for purifications or specific reactions.

For industrial large-scale bioprocesses, high amounts of different buffers are needed. This is associated with specific challenges, e.g. defining and tracking hold times or storage capacities. Inline buffer dilution overcomes these disadvantages.

This article will give an overview of the inline buffer dilution process and discuss its benefits compared to traditional formulation of buffer solutions.