A Strategic Assessment Tool For Modernizing Buffer Preparation In Biologics Facilities

Surveys and discussions from industry groups suggest a gradual paradigm shift in bioproduction buffer preparation over the next decade, driven by evolving biopharmaceutical ecosystem and the complex operations in the biomanufacturing facilities. While some facilities maintain a pure made-in-house operations, some leverage a combination of different buffer strategies and technologies like in-line dilution to optimize their efficiency. However, determining the optimal hybrid set-up can be challenging due to a given buffer strategy often has trade-offs like cost and flexibility.

A multi-criteria assessment framework is introduced here, allowing users evaluate the mix of buffer strategies in multiple criteria that can be prioritize and weighted based on their organizational preferences. By utilizing the framework and the assessment tool, biomanufacturing facilities can perform rational analysis during the initial strategic decisions for buffer preparation and conduct periodic reviews of the decided buffer strategies.