Author Archives: S. Anne Montgomery

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…

End-User Considerations: How Biopharmaceutical Companies and Their Employees Approach Single-Use and Stainless Steel

Along with the other perspectives offered in this special issue, people tasked with actually implementing and working with single-use, stainless-steel, or the more common variations of hybrid systems deserve a say also. When seeking out end-user comments, however, we should consider both the overall company decisions about which systems to use (decisions that may not have accommodated much input from the manufacturing floor) and opinions from individual scientists, technicians, and process engineers themselves who are presented with the facility design and…

From the Editor

The BioProcess International Conference took place during the last week in October in Boston, MA — when technical editor Cheryl Scott and I enjoyed meeting with so many of our readers, authors, and advisors as well as the BPI sales staff. We always receive good suggestions from our editorial advisors in our annual meeting with them, and the technical presentations help us craft the final version of our 2016 editorial calendar. As always, congratulations to our Informa colleagues at IBC…

From the Editor

Along with products and processing operations moving upstream and downstream, they also move toward the mainstream. The ramifications can become so interconnected that it is hard to discern cause and effect. One example from the past 10 years is single-use materials moving into larger scale processing. That in turn has driven much exploration into flexible operations and variations of continuous processing — neither particularly new concepts, but both now taken into more (potentially) economical directions. Related discussions are bringing heightened…