Author Archives: S Anne Montgomery

From The Editor

Quality control isn’t only a scientific priority; editorial QC, proofreading, and knowing when and what to question is becoming more and more complicated, even as (ironically) the Internet facilitates research and information sharing. Plagiarism can be entirely unintentional. Most accomplished editors notice when a paper seems pieced together and styles clash — one reason that we copyedit fairly rigorously in BPI. But you have to work harder to infringe a copyright. Editors worry whether authors have acquired proper permissions to…

From The Editor

Only recently did I finally get to watch the film Contagion, which was released this past fall. Sometimes the most provocative tests of our imagination come from our extreme fictional interpretations, and I was hopeful. (But remember Outbreak, the disappointing (if earnest) movie from the 1980s?) And I do believe this is a film worth recommending — both within and outside the industry. Mostly taking place in biosafety-level laboratories, Contagion does show how hard it is to isolate and grow…

From The Editor

One disadvantage of having covered this industry for so long is that we can get too used to terminology that is no longer quite adequate. This emerged in discussions with our advisors and readers throughout the creation of our anniversary awards program. For want of other available terms, BPI has (from the start) rotated issue themes of upstream, downstream, and “manufacturing” — that third category or “pillar” that encompasses filling and finishing and activities that occur throughout process and product…

From the Editor

This issue marks the beginning of BPI’s tenth volume of publication. We debated how and when to launch our tenth-anniversary year: Issue 1(1) was published in January 2003, but the magazine was actually “born” in mid-2002 with its adoption by Informa. We founding editors had six months in our 400-ft2 Eugene, OR, office to build an acquisitions database, create a manuscript pipeline, and design the magazine’s first templates. (A radical idea: BPI was designed by editors, who still create all…

From the Editor

      Kudos once again to our IBC colleagues for another excellent BioProcess International Conference and Exposition. Throughout the week of 31 October– 4 November more than 1,400 attendees and 125 exhibitors engaged in lively discussions on critical issues affecting our industry. The Long Beach, CA, convention center proved to be a comfortable and accessible venue for multiple session tracks, technical workshops, and seminars. Among the trends and topics that made frequent appearances in presentations were the ongoing challenges…

From The Editor

      In one company I worked for, we were all given a year to participate in a project called “Budget Busters.” Each person and department was tasked with figuring out ways to save operating costs on all levels. Monthly cash awards were given to those who had made significant contributions to the program. Our mailroom manager created notepads for us from scrap paper. We began reusing manila folders, and our editorial department began using both sides of manuscript-tracking…

From The Editor

      Not long ago I assembled a few current and former coworkers to meet with a young woman who is contemplating a career in journalism. Part of that visit involved comparing experiences of those who had been in the field for many years with those who had finished their formal education only a few years ago. We wondered whether the field still welcomes newcomers with degrees other than in journalism; or whether publishers now insist on that specific…

From the Editor

      Conference themes and approaches can be looked at as sort of a crazy quilt representing the state of the industry: with pieces of all different shapes and colors that come together to form a cohesive whole. They fit together in many ways, depending on the organizers (quilters?); many pieces are omitted and saved for the next quilt. But how to find the most successful combinations requires technique as well as imagination. Here are some topics I’ve been…

Fill and Finish for Biologics

    As most novelists will tell you, if you make substantial changes to the beginning of a story, you may well need to revise your preestablished conclusion. Similarly, as approaches to process design and development change, new tools, technologies, and various shifting “paradigms” also affect the way companies approach final formulation, filling, and finish steps. As yet another ref lection of increased process understanding and quality-by-design’s (QbD’s) holistic approach to biopharmaceutical development, those final steps — traditionally outsourced by…

From The Editor

          Early on in the life of BPI we offered a few “closer” pages that we called “Defining Moments.” It was to be a forum for distinguishing between terms that are misused and for proposing new definitions for new approaches. In fact, because one particular topic came up again in a conference I attended this past January regarding the terms analytical and bioanalytical, we decided to revisit one of these entries from 2005 (with a few…