From the Editor - March 2015

In this month’s lineup, you’ll find a common theme of balancing operating costs against company cultures and corporate philosophies. This is far from new: You can’t responsibly run a business without making such calculations! But the value in taking a fresh look at them lies in how we are forced to dust off and reassess some assumptions (even prejudices). It is easy (and all too human) to persist with outmoded assumptions — and we cannot afford to do that given the rapid rate of change over the past century. Analyzing the repercussions and complex interrelationships of all factors that contribute to success appears to require ever greater sophistication of predictive and analytical methods.

Herein you will find another set of ROI calculations in the continuing series by Sid Jain. He presents a highly pragmatic, multifactorial approach that echoes some technical design-of- experiment reports — and you can decide whether and how to incorporate it into your company’s overall operating strategy. His analysis is based on the world that is, not the world that was even just a few years ago. As the industry becomes more globally integrated, decisions to move certain operations to lower-cost regions may indeed make good business sense in light of improving harmonization of quality control, regulatory compliance, and training. Although we editors usually delete opening statements referring to the “ever-maturing biopharmaceutical industry,” we cannot deny the fact that as the world moves on, we have to guard against being stuck in even the very recent past if it is no longer a constructive mindset.

Other articles in this issue include approaches to analyzing cost effectiveness and big-picture planning. Ron Rader and Eric Langer present historical data on commercial-scale bioprocessing — confirming what many in the industry have been saying for several years now. As downstream operations began to be overwhelmed by increased upstream titers, this topic has progressed from cavalier comments about “just throwing away product that can’t be handled downstream” (which I remember hearing from some speakers only a few years ago) to examinations of how to reduce time and cost and increase yields and profitability downstream.

The “holy grail” sought by bioprocessors over the past decade has been successful reduction of purification time and cost. Nicole Ulmer, et al., report on improving load, productivity, and product concentration in batch chromatography, detailing their own tactics for reducing resin and buffer costs. Melissa Holstein and colleagues show how using an intermediate wash step can extend column lifetime, and Larry Castleman describes how to predict service life and failure of elastomeric seals. His topic is of interest overall to fill– finish operations, but it also should be useful to companies assessing costs and efficiencies of single-use components.

It isn’t all about economics, of course: It is as much about the people who do the work as well as benefit from it. As we hope to show through our continuing look at niche/orphan diseases, and as Nancy Davenport-Ennis emphasizes in this issue’s Elucidation, the ultimate goal is to improve the human condition while making money to enable such work to continue. Benefiting from the biopharmaceutical industry’s legacy of innovation, new generations can challenge outmoded assumptions and push forward. The future of this industry rests in providing them with the tools they need to build upon what has come before.