June 2019 – From the Editor

Often we are pleasantly surprised at thematic connections that fall within an issue or come between an issue and its supplements — sometimes planned, sometimes a matter of happy coincidence. Setting an issue theme of continuous processing with a featured report on large-scale capacity strategies inevitably created some overlap. At this stage of maturation in its brief history, the biopharmaceutical industry offers myriad choices for facility design, process development, manufacturing paradigms, and partnering arrangements. With many successful examples to choose from, a company can adapt numerous technologies for accelerating processes and reducing final costs to patients.

We could make the increasingly common mistake of thinking of everything as falling under the broad term of intensification. Editors often take the big-picture approach, finding interrelationships and commonalities and drawing stories from them. The danger comes in muddled thinking and oversimplification — which at the level of corporate planning can be costly, if not disastrous. As editorial advisor and frequent BPI contributor Bill Whitford points out in this issue, what is related isn’t necessarily synonymous although it often can be treated as such. You might argue that it doesn’t matter so much what you call something, that the model chosen is what works, whether you are basing a facility or process design on fixed or disposable equipment or varying degrees of both. But accuracy of terminology does matter. As Whitford points out, “ambiguity and lack of precision can lead to inefficiencies and errors across the industry or even within individual companies.”

Continuous processing is a major contributor to process intensification — and with decisions made ever earlier in process development setting facility design for the life of a given product, it very much matters whether the goal is simply to combine/simplify steps; to build on continuous operations; or to design for single-use, stainless steel, or hybrid operations. Each decision made affects the possibilities available for making the next, and so on. Our friends at the BioPhorum Operations Group (BPOG) illustrate the point well in this month’s featured report, deftly bridging those themes in the larger context of capacity strategy. And Sartorius Stedim Biotech authors emphasize that point with a focus on the specific effects of taking the single-use option.

Meanwhile, Whitford highlights intensification in light of some facility-design options (the featured report theme) to which the different paths of process development are leading biopharmaceutical companies in the 21st century. He thus places continuous processing into a larger perspective — highlighting perfusion culture along the way — before a group of authors from AbbVie drill down into the specifics of just one downstream processing project. We further explore many wider aspects of continuous separation/purification with both an industry roundtable and a one-on-one interview that concludes this issue.

We hope the end result is less blurry than it is enlightening. And we look forward to your contributions to the continuing story.

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