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…
Author Archives: S. Anne Montgomery
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…
From the Editor
I am writing this shortly after BPI’s publisher Brian Caine and I conducted some interviews at an east-coast supplier company. Our experience there reinforced our rationale — from the start of this publication — for continually seeking ways to build on the collegial, collaborative nature of relationships in our industry. I’ve been covering this industry as an editor since 1989; Brian, Cheryl Scott, and Maribel Rios have been involved since the mid-1990s — so we have seen technologies come and…
From the Editor – March 2015
In this month’s lineup, you’ll find a common theme of balancing operating costs against company cultures and corporate philosophies. This is far from new: You can’t responsibly run a business without making such calculations! But the value in taking a fresh look at them lies in how we are forced to dust off and reassess some assumptions (even prejudices). It is easy (and all too human) to persist with outmoded assumptions — and we cannot afford to do that given…
From the Editor
In this month’s lineup, you’ll find a common theme of balancing operating costs against company cultures and corporate philosophies. This is far from new: You can’t responsibly run a business without making such calculations! But the value in taking a fresh look at them lies in how we are forced to dust off and reassess some assumptions (even prejudices). It is easy (and all too human) to persist with outmoded assumptions — and we cannot afford to do that given…
The 2014 BPI Awards: Recognizing Excellence in Bioprocessing
The mission of the BioProcess International publication has always been to deliver valuable industry information to the biotechnology community to continue on the path of scientific advancements, revolutionary technological applications, and strategic partnerships and collaborations. We are honored to cover this market and work with the many talented people sharing their expertise and projects. Now is the time for us to recognize and honor the outstanding people, organizations, and technologies that have significantly influenced and advanced the efficiency of biotherapeutic…