Author Archives: S. Anne Montgomery

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…

Manufacturing Strategies for Regenerative Medicine Success

Just a few years ago, my requests for manuscripts detailing logistical considerations for cell-therapy manufacturing were met with puzzlement. The assumption seemed to be that such processes already existed for commercial biopharmaceuticals and would simply be adapted later. In quite a few cases, adopting a commercial mind-set did not appear to be a goal at all, with hands-on practitioners used to applying procedures in hospital settings. For those of us who remember early discussions about commercialization and cost-containment for protein…

From the Editor

We have had a busy summer, first adding to our annual Yearbook issue a supplement summarizing the well- attended presentations from our BioProcess Theaters at the Interphex and BIO events. And this month you are receiving our regular issue and annual guide to the upcoming BPI Conference and Exposition (25–29 October in Boston, MA) along with a sponsored supplement introducing cell-therapy initiatives at Pall Life Sciences and the third part of our special- report series featuring CMC Strategy Forum consensus…

Ask the Experts: Core Technologies Expand Opportunities for Cell Therapy Manufacturing

Pall Life Sciences has long been known for its expertise in processing and filtration equipment for the biopharmaceutical industry. In recent years, the company has broadened its offerings in upstream manufacturing by expanding its core capabilities in the single-use, bioreactor, and microcarrier arenas, with unique and innovative technologies for cultivation of cells to be used as therapies. Read the full text of this article in the PDF (Login required).

From the Editor – August 2015 Supplement

Welcome to our first full issue of summaries from our 2015 BioProcess Theater programs. This is a bit of a different concept and format from our regular issues and supplements, so a few words of explanation are necessary. At the Interphex conference (21–22 April 2015) and the Biotechnology Industry Organization’s annual convention (16–18 June 2015), BPI again organized and conducted presentation programs within the exhibit halls. We have been holding the BPI Theater @ BIO for eight years now, and…

From the Editor

More often than we realize, industry literature suffers from discrepancies in definitions of (seemingly) common, basic terms. We have pointed this out before — twice addressing the differences between analytical and bioanalytical testing, for example, and cautioning against misunderstanding the distinctions. Some terms are interchangeable, though, or it may be too soon to separate them from one another (e.g., cell therapies and therapeutic vaccines). We editors accept much of this as normal. Differences in interpretation will persist, and often a…

Special Report: A World of Difference — Biosimilars and Biobetters Offer Unique Benefits — and Risks

by John Otrompke, with Cheryl Scott and S. Anne Montgomery When the United States Food and Drug Administration (FDA) approved the country’s first ever biosimilar on 6 March 2015, it had been a long time coming. After all, the European Union had approved the first biosimilar in 2006, and a number of others have followed in Europe since then. Still, the approval of biosimilar filgrastim, a recombinant colony-stimulating factor used to offset the complications of chemotherapy, was a welcome step…