Buffer solutions are essential for all biologics processing, and preparation of these solutions can easily become a bottleneck for production, particularly in existing facilities. Process intensification of upstream operations creates larger demands for downstream processing, and thus, increases in buffer consumption. This has put strain on buffer preparation operations, often restricted by the facility’s capacity or footprint for buffer storage. In this work, in-line buffer conditioning (ILC) was assessed as a solution for improving manufacturing facilities’ capability, compared to traditional buffer preparation. ILC is defined as the simultaneous dilution and titration of single-component stock solutions. The systems of three different vendors were tested. Method development, control strategy, reproducibility, and accuracy of these systems were evaluated to determine the ease of use and feasibility of implementation. One system was tested to support an end-to-end, fully integrated downstream process (ICB) for a 100L bioreactor campaign of 45 days, reducing labor resources by 50%. For some facilities, pilot-scale intensified or ICB processes cannot be supported without the use of an ILC system. Here, we show the benefits of ILC implementation, particularly for companies with a platform downstream process. Results from this evaluation advise instrumentation selection and implementation strategy for existing and new facilities, both batch and ICB, based on a high-titer antibody model. 

Assessing in-line buffer conditioning for implementation and facility benefit for traditional and ICB manufacturing applications

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.