From the Editor September 2015

S. Anne Montgomery

September 23, 2015

3 Min Read

FtE-SAM-263x300.jpgWe 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 papers.

Our Vendor Voice section is now called Supplier Side. We first considered this change when one long-time industry contact commented that “vendors sell hot dogs.” This new name also reflects the increased attention these days to strategic supplier–user relationships.

I am delighted this month to bring you an article from the Golden LEAF Biomanufacturing Training and Education Center at North Carolina State University’s College of Engineering. It describes an extensive program for training FDA investigators. Specific topics outlined in the course descriptions might serve as a guide for your own in-house training and education. It also helps us better categorize some analytical techniques by process stage. If you see topics for papers you might submit or especially would like to see (e.g., how-to, protocols, applications), please let me know! In attending industry events over the past couple years, you probably have noticed a marked shift in the overall age range of attendees. So which analytical techniques might encompass legacy issues that are not otherwise being addressed?

This issue’s production theme offers two different approaches to bioreactor design. The series by Marcos Simón concludes with an in-depth analysis of process economics in developing a bioreactor for adherent-cell cultures. And in our first Supplier Side, part one of a two-part series looks at fluid dynamics of a single- use, stirred-tank bioreactor for mammalian cell culture. Both articles reflect the increasing sophistication of bioreactor designs and the flexibility that single-use materials offer.

For five years now, BPI has helped drive an exchange of information concerning regenerative medicines in development. The second of this year’s two cell- therapy supplements will appear in October. But first, we are delighted to bring you this month’s supplement sponsored by Pall Life Sciences. It shows how one company can launch itself into a new area of business from a solid foundation of long- established technology platforms.

October brings with it our annual BPI Conference and Exposition. Our colleagues at IBC Life Sciences have assembled another program of cutting-edge presentations, and the Hynes Convention center offers a comfortable venue for networking. I hope you enjoy the annual conference issue this month, with its interviews from many speakers. You can find the complete podcasts online at www .bioprocessintl .com/bpi-2015-podcasts. For more detail than our schedule at a glance provides, find updated program information online at

BPI will bring you much new reading material the rest of this year. Look for an in-depth report on product “developability” and an exploration of change-control notifications for single-use materials (October), a major report on sustainability initiatives (November), and a second single- use supplement published alongside our annual “bioexecutive” issue in December.SAMfix-sig-300x73.jpg

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