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

Biopharmaceutical development and production requires the investment of significant time and resources. To minimize failure risk and ensure targets are met, manufacturing procedures must be efficient, robust and productive. As product titers increase, this becomes more difficult as greater volumes of process buffer are required to meet demand. Larger buffer volumes place additional pressure on buffer hold and storage area constraints, and complex scheduling of staff and equipment is necessary to ensure adequate quantities are ready for an entire batch.

In light of these logistical challenges, identifying the right buffer preparation strategy for a given facility and operation is key. This presentation offers a holistic approach to buffer management to enhance several measures of efficiency and improve quality. We 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 are shared to assist with the economics and logistics of the buffer journey. And finally, we show how the best buffer management approaches come together to deliver significant operational benefits — allowing biologics manufacturers, including CDMOs, to remain nimble and competitive.