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Buffer management strategies in downstream processing
Buffers play a significant role in biopharmaceutical manufacturing. Typically representing the major component by volume used in biopharma downstream processing steps, buffer preparation constitutes a significant proportion of a facility’s footprint, labor requirements and equipment cost.
There are multiple ways buffers can be supplied: an established way to manufacture buffers in-house is with the use of USP or WFI grade water to hydrate powders in stainless steel or single-use tanks.
While this method is established and ideal for large volumes, these operations need significant infrastructure. This includes warehouse space for holding raw materials prior to use and a weighing and dispensing area for raw materials.
Therefore, looking at the cost and complexity of in-house buffer preparation, the adoption of hydrated, premade liquid buffers and buffer concentrates can be a cost, time and resource saving alternative.
Optimize your buffer preparation processes
Depending on the size of the biopharma manufacturer’s operations and facility, different buffer management strategies can be applied either as a stand-alone solution or in combination with other strategies to achieve workflow improvements:
- Traditional in-house buffer process, using water-for-injection (WFI) to hydrate powders in stainless-steel or single-use tanks
- Ready-to-use cGMP buffer solution
- Buffer concentrates, used in conjunction with inline dilution
- Buffer stock concentrates to be used in conjunction with buffer stock blending
Understanding not only the alternative buffer management strategies available, but also what resources are needed to execute them, can help ensure you have the tools necessary to remain competitive in today’s growing bioprocessing industry.
It is common for biologics manufacturing processes to require hundreds of raw materials, ranging from media and media supplements, buffers, and salts to other process chemicals.
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