From the Editor

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With the approaching holiday season and the end of the year — how can that be? — we find ourselves pretty well settled into plans for our 2014 editorial calendar. As a team, we’ve met during the summer to brainstorm and share the results of our research into the subjects of next year’s special reports and supplements. What should we focus on next? What old themes and supplement topics need to be revisited, and what new topics should we highlight? Is there another trend to follow such as we did with early promotion of single-use technologies? Such planning is always a combination of market studies, reader and advisor suggestions, our own editorial interests, advertiser and sponsor recommendations … and a bit of cautious guesswork (that is, prognostication). We’ve tried always to help present bigger-picture views into how various advances can encourage progress across more than one industry segment, but we also don’t want to oversimplify matters.

With its downstream theme, this issue follows a number of topics that have been represented in publications and conference tracks over the past year. Eric Langer looks at the fast-growing but tentative market for membrane adsorbers. Martin Wisher of BioReliance offers his first of a series of European regulatory perspectives, this first paper addressing the timely subject of risk-mitigation for raw materials used for biomanufacturing. And editorial advisor Pete Gagnon presents some work of his group in Singapore toward practical options for reducing dependence on protein A (a topic reviewed by Blanca Lain in our September special report).

Our editorial schedules being as doubled-up as they are these days, I am writing this (in fact) as I look out over the sunny Boston skyline near the Hynes Convention Center, anticipating the start of the annual BPI Conference and Exhibition tomorrow morning. Our IBC/IIR colleagues also approach our shared subject matter through research and consultation with advisors, and we continue to enjoy our now many fruitful years of working with them, exchanging ideas and resources, and looking for the “next big thing.” At this point, that could be the shared influence of a number of technical and analytical advances on the industry as a whole. We see the emergence into greater prominence of new options for biopharmaceutical manufacturing, expanding the focus and shared technologies and analytics for work with antibodies, nonantibodies, antibody–drug conjugates, recombinant vaccines, and regenerative medicines. The work toward optimizing and reducing clarification and processing steps is beginning to yield some exciting new technologies (as presented in this issue by Pete Gagnon); and senior technology editor, Cheryl Scott, has been (and will continue next year) highlighting the history and applications of key analytical techniques and instrumentation (old and new) underlying all phases of biotechnology drug development. It is far from a one-size-fits-all industry, yet groups continue to learn from one another and adapt technologies for their specialized needs.

In 2014, we will bring you an expanded cell-therapy supplement that will include updates on tissue and gene therapies; a single-use issue focusing on user perspectives and the work toward driving consensus among several groups developing single-use standards; an updated look at outsourcing approaches; and our first full supplement on antibody–drug conjugates. Special reports will take a look at analytics, immunogenicity, and efficiencies being introduced into downstream processing. Add to all that another BioProcess Theater at the BIO Convention and a new such theater at Interphex — and a new, biannual BPI Awards program — and we will have more than enough to keep us busy and you reading! And as always, thank you for following the industry’s journey with us. We can’t do this without you!

 

 

 

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