Author Archives: S. Anne Montgomery

September From the Editor

Some issues of BPI more than others emphasize to me the interdisciplinary nature of our audience. One example: I am happy to bring you the latest consensus paper from the CMC Forum series. In its discussion of host-cell protein control strategies, the authors write of their goal to “bring industry, academics, and regulators together for generating integrated perspectives on HCPs and their control.” Those three groups — industry, academics, and regulators (government) — constitute three major categories of our readership…

From the Editor

Our second annual BPI Theaters supplement once again brings you summaries from presentations at our BioProcess Theaters during Interphex and the BIO Convention.As a summer companion piece to our annual Yearbook’s company profiles and application notes, this serves as a midyear overview of the biopharmaceutical landscape. These summaries are the highlights.To hear the full presentations (and see their PowerPoint slides) please go to www.bioprocessintl.com/Interphex2016 www.bioprocessintl.com/BIO2016 This special summer issue comes to you through the efforts of many people.Our publisher, Brian…

Moving Toward a Continuous Future

During the March 2016 BPI West conference in Oakland, CA, BPI publisher Brian Caine and I had an opportunity to meet with Michael Egholm, PhD, Vice President and General manager of Biopharmaceuticals at Pall Life Sciences. We are pleased to be able to share his thoughts about Pall’s support of continuous processing — and the company’s current offerings. Montgomery: Not everyone seems to be defining continuous processing in the same way. What is your general concept of it? Egholm: At…

Center of Excellence

Enabling Continuous Processing Using a Step-by-Step Approach

Mario Philips is Vice President and General Manager of Single-Use Technologies at Pall Life Sciences. In February, he spoke with BPI publisher Brian Caine and editor in chief Anne Montgomery about Pall’s commitment to enabling continuous processing and its development of single-use technologies. In that discussion, he addressed some major process bottlenecks and Pall’s solution to them, including centrifuge replacements by continuous acoustic wave separation, continuous chromatography with multicolumn chromatography technology platform, and a simplified version of tangential-flow filtration. Read…

From the Editor

Audience: the key element behind all style and content decisions in any spoken or written material. When publications existed only in print, audience-related criteria were easier to maintain than they are these days. Bound periodicals lived in libraries sequestered by subject. Unless you knew where “your” material lived, you were unlikely to stumble upon it — but information could get lost. Manual crossreferencing wasn’t easy, and I would not want to return to the days before powerful Internet search engines!…

Contract Manufacturing of Cell Therapies: A Conversation with MaSTherCell’s Eric Mathieu and Thibault Jonckheere

The work of developing advanced medical products is spreading around the globe, and with it comes specialized contract services. Far from a “one size fits all” approach to development, and with few platform technologies yet available, contract service providers in the advanced therapeutics space must focus on helping to move promising science into good manufacturing practice (GMP) environments, but with regulatory pathways and eventual harmonization still under development. One company that formed to address the specific needs of cell therapy…

From the Editor

Every now and then in the biopharmaceutical industry, a technology or concept seems to take hold and suddenly appears everywhere — in print, at conferences, in workshops and online media offerings, and as part of new product launches. This happened in the 1990s when process validation was (seemingly suddenly) the theme of the day, and it happened briefly later that decade when transgenics appeared to be a potential game changer. Single-use technologies of course precipitated arguably the most widespread set…

From the Editor

Included with this issue is our first of two supplements this year focused on cell therapies. It has been fascinating to watch this journey toward maturation of advanced therapeutics. Some early assumptions that commonalities with protein production would resolve manufacturing problems are being tempered now that we know more about the unique demands of cell and gene therapy development. Still, the future looks brighter for these new modalities. As Invetech’s Richard Grant (global VP, cell therapy) noted in his plenary…

From the Editor

Travel in January turned out to be more of an adventure than many of us anticipated. Two events that BPI attends in January were in Washington, DC: Phacilitate’s cell and gene therapy conference (part of its Washington Leaders Forum) and the CASSS Well Characterized Biotechnology Products conference (along with two CMC strategy forums). These two events present topics that we see carried throughout the year, including FDA initiatives and current regulatory, quality, analytical, and manufacturing focus points. Organizers of both…

From the Editor: BioProcess International House Style

One of my ongoing projects is to revise our author guidelines for better presentation online. Most publications have formal house-style guidelines to ensure clear and accurate communication. Editors are not immune from making mistakes, but as a reader, I distrust the accuracy of information in text that is (overall) sloppily edited. It is like not wanting to eat in a restaurant with a dirty kitchen. How can I trust the quality of the food? But styles can become outmoded, and…