When Questioning the Status Quo Leads to Bio-Manufacturing Success

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“I’m somewhat embarrassed to admit that my PDA membership lapsed well over 10 years ago. That wrong was righted when I rejoined the PDA late this summer and immediately plugged into the very active New England chapter. My first event back with PDA was this past Wednesday at the Bristol-Myers Squibb site in Devens, MA. They hosted a set of presentations from BMS experts on their latest facility design principles, process design, and closed systems thinking that drove their most recent facility.

Sanchayita Ghose, BMS’s Director of Process Development, spoke about key process redesigns that allow near-continuous processing of monoclonal antibodies. Rethinking the fed-batch vs. perfusion question not as an either/or but rather either/and allowed BMS to merge perfusion bioreactor stages with fed-batch stages to maximize protein productivity and set up downstream purification for continuous processing success. Downstream purification redesign involved multicolumn capture chromatography, tandem column linking to eliminate pooling steps, and auto-titration for low-pH viral inactivation. In aggregate, these steps allowed BMS to significantly increase throughput and productivity in a smaller footprint plant. This was an impressive example of selectively applying principles of continuous processing to drive bio-manufacturing success.

The second half of the program was presented by Richard Martel and Paresh Kurkure – both Manufacturing Support Engineers – who spoke about creating truly closed operations within single-use platforms. By refusing to accept conventional wisdom on the feasibility of closing certain process steps, Paresh and Richard were able to design fully-closed processes that seemed to be widely considered non-closable. These closed operations allowed the facility design team to maximize the use of controlled-not-classified space within the facility, thus making significant operational and overhead savings. Classified space within the facility is limited to operations that are not fully-closed and would have a much smaller classified space footprint than if the closures had not been made.

Both presentations were fascinating examples of thinking unconstrained by conventional wisdom or status quo, ultimately resulting in very real quality and productivity improvements that allowed BMS to continue bringing therapies to patients. I’m looking forward to further thought-provoking presentations from the PDA New England Chapter in the future.”

- Aaron Hubbell, East Coast Regional Director at Delta PM