From the Editor: January — February 2024

With Anne Montgomery’s retirement this past November, I am now the last founder standing on the BPI staff. It began in 2002 as an idea from Brian Caine and Stephanie Schaffer on the business side with Anne and me on the editorial side, and we put out our first issue in January 2003. Now the brand includes conferences in Boston, San Diego, Europe, and Asia; a training academy; an online news outlet; webinars and custom publishing; and of course the publication that you hold in your hands. And I lost track of the number of people who were closely involved when it went past a couple dozen.

For me, taking over as editor in chief after all that time is absolutely the end of an era and beginning of a new one. For the other editors, it is sure to be a period of adjustment. But for the publication and its overall brand, this is merely the next step in a continual evolution. I’m sure that readers and conference goers will barely notice. Authors and editorial advisors are in for a few (hopefully good) surprises. And some operations will change behind the scenes.

For over 20 years, I’ve been a process- and product-oriented workhorse — often joking that it was time to put on my blinders, duck down, and plow ahead when things needed to get done. Editor-in-chiefdom forces me to take off those blinders and lift my gaze to see the big picture every day, though I’m doing my best to be “chiefly” in the mornings and remain an editor in the afternoons. That seems to work just fine so far: I’m in the US Pacific time zone, and much of our business seems to happen in the first part of my day anyway. But it does mean that you can expect a more immediate response from emails earlier in the day.

There I go again, getting into the weeds of things. It’s where I live when I’m not gardening, doing barn chores, riding my horse, shopping farmstands, or hiking the Oregon countryside with my Labrador. I’ve learned everything I know about the biopharmaceutical industry — and about business press publishing — on the job and in the thick of things, and thanks to Anne’s mentorship along with the invaluable advice from our editorial advisors over the years, I feel well prepared to take the reins.

Speaking of learning on the job, I’d like to introduce you to our new associate technical editor, Sarah Stefancin. Based outside Cleveland, OH, she is a 2021 graduate of the University of Mount Union who worked as a toxicology report writer for Frontage Laboratories before joining us. She’s as new to bioprocessing as I was when I jumped into this pool at her age nearly 30 years ago, and I recognize much of myself in Sarah’s confident and curious approach to our subject matter. And she is the first BPI editor not to be based here in Oregon — as we move with the times in this post-COVID reality.

If you’re involved on the production side of our Ask the Expert webinars, you already may have met Sarah virtually because she took over the reporting aspect of that series quite handily and almost immediately upon joining our crew. That gives our more established associate editor, Josh Abbott, the room he needs to take ownership of our focus-on articles — which in turn allows managing editor Brian Gazaille and me to focus much of our attention on the technical side of things. We hope that this reshuffling of editorial work will help things go smoothly in the future. And it should give our authors and advisors a good idea of who to contact for what, something that hasn’t always been so obvious. . . .

And there I go again, talking about processes. Well, this is BioProcess International, after all! Standard operating procedures, product quality attributes, process optimization, and the like make up our bread and butter around here — and yours too. We’ve always made the point that the Process in our name refers to the entire process of biopharmaceutical development: not just manufacturing, but also product characterization, developability assessment, formulation, business and project management, outsourcing, regulatory affairs, hiring and training, analysis and quality control, supply chain and logistics, and so on. From the outside, it may seem like pretty narrow coverage — but we know (because we’ve learned it from you) that the breadth of topics is surprisingly wide within our niche.

Managing the publication is a little bit like that. Many readers are surprised to find that the editors are also designers — making figures and tables and layouts and such — in addition to being interviewers, writers, and hands-on copyeditors. We all seek out expert contributions (the “meat of the magazine”) and commission papers from freelancers as well. We all travel and meet with authors and readers and advertising clients — and we all work on custom projects for our supplier friends too. By necessity, we work closely with our sales representatives, production crew, webmasters, and publisher to plan coverage and schedules. We enjoy our colleagues and can’t imagine doing things any other way.

So welcome to 2024. It’s an election year in the United States of America, and we expect the usual political craziness to multiply if not exponentially then at least factorially. (For example, it’s rumored that campaign spending will far exceed the billions of dollars that circulated in 2020. And the events of 6 January 2021 weigh heavy on our minds even now.) Your industry is likely to take a few financial and public-relations hits along the way, and there’s no telling what kind of unforeseen events could derail operations around the globe. Weather, warfare, and other world events can upset even the best-laid business plans, as we’ve all learned in recent years. It’s best to cultivate flexibility and rapid-response capability — and not to ignore the red flags when they appear.

The authors in this issue and featured report offer several approaches to help you build such a mindset, whether it’s future-proofing your workforce, setting people up for success, or planning now for changes ahead. On the technical side, we’re scaling up and managing risk, ensuring product quality through environmental monitoring, analytics, and process engineering. So let’s get into the weeds together — but keep that big picture in mind.