Buffer Management strategies: How to Stay Nimble and Competitive in Biologics Manufacturing

Biopharmaceutical development and production requires the investment of significant time and resources. Manufacturing procedures must be efficient, robust and productive to minimize failure risk and ensure targets are met.

With increasing product titers, greater volumes of process buffer are required to meet processing demand. Increased buffer volumes place additional pressure on buffer hold and storage area constraints, particularly for companies that prefer to prepare their buffers in advance. Complex scheduling of staff and equipment is necessary to ensure there is an adequate quantity of QC-released process buffers prepared and ready for an entire batch. These logistical challenges increase in plants producing multiple products due to the need for different buffer solutions for different process applications. Furthermore, continuous manufacturing requires different considerations, as it requires constant supply of process buffers.

Identifying the right buffer preparation strategy for a given facility and operation is key. While holding larger buffer quantities might be suitable for a fed-batch processes, in-line dilution or conditioning deserves careful evaluation for continuous manufacturing. Operational modifications in buffer management allow manufacturers to maximize their output without significantly altering their production approach. This can enhance several measures of efficiency, including faster drug product release, increased productivity of GMP manufacturing, reduced footprint, enhanced flexibility and improved quality.

In this presentation, we will take a holistic approach to buffer management, discuss the known and unknown challenges, and consider different options of buffer preparation, weighing the merits of in-house vs. outsourcing. Conceptual design scenarios in both existing and new facilities will be shared to assist with the economics and logistics of the buffer journey. And finally, we will show how the best buffer management approaches come together to deliver significant operational benefits —allowing biologics manufacturers, including CDMOs, to remain nimble and competitive.