From the Editor: November-December 2023

As I look forward to retirement and revisit 35 years in publishing, I marvel at all the adventures that a graduate degree in comparative literature can lead to. I’d always dabbled in biology, but for some years, literature, languages, and teaching won out. By the late 1980s, leaving a dissertation unfinished didn’t help me compete for full-time community college teaching gigs. Carpentry and school-bus driving were okay for a while, and playing baroque recorder music garnered extra grocery money, but none of those offered a good insurance plan.

On 8/8/88, I began as a proofreader at what was then Aster Publishing in Eugene, OR. Ed Aster was a local character with a talent for launching niche publications, many of which still exist today: Pharmaceutical Technology, BioPharm, Spectroscopy, LC-GC, and Applied Clinical Trials, to name a few. Using typewriters, outside typesetters, waxed pasteboards, and printers’ bluelines, I learned about old-style publishing and magazine editing. Soon I joined the staff of two-year-old BioPharm magazine under Jane Ganter, my mentor and still great friend. From her, I received on-the-job journalism training in the fledgling biopharmaceutical world. Desktop publishing came and changed how we worked.

I took over as senior editor of BioPharm in the early 1990s while Advanstar was taking over the Aster publications. By 2002, however, the Eugene office was destined to close and relocate operations to New Jersey, so the time was right for a change. Under the auspices of Informa Life Sciences, we launched BPI’s first issue in January 2003 under publisher
Brian Caine with sales manager Stephanie Schaffer, senior technical editor Cheryl Scott, and me. The publication’s design has been improved by a few good designers over the years, but it remains true to our original idea: hands-on, collaborative, and responsive to the industry’s evolution. We wanted to be nimble and adapt to an industry that periodically redefines itself. The hot topics of today can cool and fade away (although some come back later). The issues that you receive are the work of four editors (telecommuting since 2007): from manuscript acquisition through peer review, editing, graphics and layouts, proofreading, galleying, and finalizing files for our production team to arrange with ads for the printer. We’ve added eBooks and featured-report inserts to explore focused themes and custom reports from the suppliers that support the industry. The BioProcess Insider team brought a separate news outlet, and a number of conferences came under the umbrella of our BPI brand. That brings us to now: a mature publication covering a maturing industry.

From the start, we’ve benefited from close teamwork among editorial, sales, and management. Our team has expanded in recent years to include marketing, multimedia, and project managers for coordination of custom projects. Another feature has been an unusual level of staff stability: The names on our masthead haven’t changed much over the years. Former associate editor Leah Rosin left only to come back later in a different role with her own support team. And our editorial advisory board remains essential to maintaining high standards of content. It’s not just a list of names, but rather an engaged group of volunteers who review manuscripts, help us find authors, and advise us in editorial decision-making.

My perspective of the industry is through the publishing lens. As an assistant editor, I was told early on that some topics would never be applicable to biomanufacturing: Benchtop instruments such as thermocyclers and small-scale bioreactors were “too researchy,” for example. We got product releases touting the conversion of stainless-steel industrial chili cookers into fermentors. Those were the sometimes heady days of inventing the modern biotechnology industry from the ground up.

Early crises included initial disappointments with monoclonal antibodies before humanization; challenges in scale-up and development of early industrial systems for pharmaceutical water treatment; first steps toward modern regulatory documents and standards before harmonization could be considered; the industry bombshell of failing sepsis treatments; a tragic death that seemed to stall gene-therapy for good; other deaths from red-blood-cell aplasia due to what the industry had yet to learn about leachables; the vagaries of economics and political maneuverings. Later came “mad cow disease” and anti-GMO hysteria; the hype and seeming disappearance of transgenics; the stunning blow from the 9/11 attacks and the new security procedures; and COVID-19. Since the founding of BPI, we’ve seen single-use technologies move to the forefront — and we are proud of our early involvement in helping to drive formation of the Bio-Process Systems Alliance. So, too, did we at BPI begin highlighting large-scale needs for cell and gene therapies – before many medical/hospital-based researchers were ready to accept that GxPs would be needed to link high quality and economy of scale.

I recall an FDA workshop championing process analytical technologies (PATs) before anyone in the room had any idea of how to apply them to biomanufacturing. Early discussions of quality by design (QbD) and 21 CFR Part 11 were almost incomprehensible. Recombinant vaccines? Biosimilars — no, that’ll never happen, said more than one expert. Huge increases in grams per liter (uh oh, what happens downstream now)? Continuous and integrated processing — could that be possible? It’s hard to remember just how disruptive some of those developments were and how the industry had to adapt in response. Just as gene therapies have returned, so too have transgenic technologies. And dare I mention mRNA and cell-free technologies?

The industry will continue to cycle through innovation, correction, regrouping, and disruptive launches into unanticipated futures. I don’t plan to wander too far away from the industry now because it certainly does get under one’s skin — and through it, I’ve met and worked with some wonderful people who have devoted themselves to improving human health. Your challenges are clear: making new generations of therapies accessible and affordable globally, balancing economic/business realities with humanitarian mandates, addressing the emergence of tropical diseases into new areas due to climate change; ensuring health access in areas torn apart by wars and political unrest. BPI was founded to cover the whole process: all the overall varied, messy, interconnected, and evolving efforts of bringing new biotherapies to market, from proof-of-concept to postmarketing. Publisher Chris Johnson will continue to help steer the ship into a new era. And under the leadership of Cheryl Scott (stepping into the role of editor in chief as I retire) with managing editor Brian Gazaille, associate editor Josh Abbott, and our new technical editor starting soon, the editorial tradition continues in excellent hands.