Wednesday, October 28, 2015

BPI 2015: Data Rules

By: Frank Corden

The explosion of readily available data is everywhere around us.  Silicon Valley is bombarding us and those who would like to sell to us with data to purportedly make our lives easier. Whether it be the articles you see on your news feed or the research you do before buying the next gadget, it seems like the current strategy is to conceive of a potential use for the data and throw it at us to see what sticks.  However, often the data isn’t timely or even useful. 

Take my commute in this morning to Boston. The warning of the traffic congestion came about 5 minutes before I hit the slow down.  Since several of the exits are more than 5 miles apart, there wasn’t time to get off Mass Pike.  But even if the data was timely, it wasn’t actionable.  Once you get to I-90 to head into town, there really isn’t an alternative route to get there.

A major theme of this year’s BioProcessing International Conference (#BPIConf) revolves around making informed decisions with data.  Whether it be on-line monitoring data, laboratory data, or process analytical technology (PAT) based data, data rules.  But what are the rules around data and how do we make it useful? What are the “rules” around using process data in bioprocessing?

I was sitting in the 8:15am presentation Evaluation of Continuous Manufacturing in a Downstream Process.  I guess I wasn’t the only one who headed into town early, the room is pretty full.  It’s great to feel the energy and enthusiasm of the group first thing in the morning.

The introduction to the Recovery and Purification track delivered by Marc Bisschops of Pall Life Sciences was provocative.  He challenged us to move from batch manufacturing to continuous manufacturing.  The benefits are clearly dependent on our ability to balance throughput of the various unit operations as you move through the process. 

Kudo’s to the first presentation, Data Based Comparison of Capture and Polishing Steps in a Continuous Mab Process.  The authors, from the chromatography company ChromaCon compared continuous versus batch approaches with hard data analysis.  By evaluating throughput, cost, and resource requirements, the analysis demonstrated that a change in the manufacturing paradigm from batch to continuous chromatography can have some impressive benefits. 

With a better quality outcome (increase in purity from mid 70% to mid 80%), you can cut chromatography resin usage by one-third.  For the resin selected, the reduction in resin usage translated into $190,000/year.  In the pilot facility studied, the breakeven for the investment in continuous chromatography occurred after the transfer of only two molecules.  Clearly, the dollar savings in a full production facility would be significantly greater. 

The decision to shift from the tried and true manufacturing approaches we use today is a difficult one.  We all realize the risk of getting it wrong is what keeps us up at night.  A delay in the release of a product not only affects our companies but also the patients who depend on these products to keep them healthy, or in some cases alive. 

Hard data to help make a difficult decision; now that’s data that rules.

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