From the Editor August 2016

Our second annual BPI Theaters supplement once again brings you summaries from

WWW.LIFETOUCH.COM

presentations at our BioProcess Theaters during Interphex and the BIO Convention.As a summer companion piece to our annual Yearbook’s company profiles and application notes, this serves as a midyear overview of the biopharmaceutical landscape.

These summaries are the highlights.To hear the full presentations (and see their PowerPoint slides) please go to

www.bioprocessintl.com/Interphex2016

www.bioprocessintl.com/BIO2016

This special summer issue comes to you through the efforts of many people.Our publisher, Brian Caine, and his team created two excellent programs, each focused on the interests of a majority of the particular event’s attendees.Sincere thanks also go to the speakers — who graciously contend each year with exhibit-hall noise, uncertain attendance, and occasional loudspeaker interruptions.Their efforts are rewarded by lively conversations after the presentations.Inclusion in this issue and on our digital site helps them reach BPI’s global audience.Thanks also go to our editorial assistant, Alison Center, who listened to each recording to take careful notes and write the summaries.And our marketing and digital content strategist, Leah Rosin, prepared the online files for you, linking the full recordings with the slide presentations.

Because some of these summaries do not appear in the order in which the presentations occurred, we have kept the original date of each presentation in the page headers in case it makes it easier for you to find the recordings online.So one or two of those dates will appear to be out of order, but that is indeed intentional.

These presentations further emphasize a point that I think few would argue against: Our industry is undergoing a number of critical transitions.Now that we understand better the scope of quality by design (QbD) principles and are generally convinced of the advantages of single-use products, new analytical and monitoring technologies for in-process control are enabling increased process and product knowledge.Advanced therapeutic explorations are driving modifications of existing equipment and technologies, and those in turn affect contract service relationships, the scope of partnering agreements, and geographical expansion.Advanced therapeutics and new modalities in general benefit from the work that has preceded it for large molecular entities, but they introduce new design challenges.Long-debated possibilities are nearing reality for biosimilar production and continuous processing.

The BPI Theater at Interphex this past April focused on two major issues: single-use technologies and their enabling of sensor development, downstream efficiencies, and continuous processing.Issues of particulate contamination and environmental monitoring came into play in those presentations as well.The overarching issues touched upon in the roundtables highlighted the industry’s progress toward harmonization of technologies and best practices — and how all those advances in materials and methods are influencing how companies select outsourcing partners.

Another Interphex roundtable presentated a topic that we are planning to cover in further detail in our December supplement: training.Moderated by BPI publisher Brian Caine and Gary Gilleskie of the Biomanufacturing Training and Educational Center (BTEC) at North Carolina State University, speakers talked about how to train employees for new processes, develop process-oriented training for single-use technologies, introduce theory-based training, and enhance automation competencies.As new generations of bioprocessors enter the field, such investments in training will improve manufacturing efficiencies and speed to commercialization.

The BPI Theater at BIO then focused on two different topics: the promise of emerging therapies and related commercialization and manufacting challenges; and a complementary focus on novel technologies and techniques.The Tuesday speakers looked at process development issues for GMP production of gene therapies, continuous chromatography applications in clinical processing, manufacturing and delivery challenges, training, and issues associated with industrializing and commercializing cell and gene therapies.The Wednesday sessions looked at the future biopharmaceutical landscape before moving into presentations about making the most effective outsourcing decisions — and what choices a company might have for outsourcing, insourcing, and long- and short-term partnering arrangemetns, as well as the rationale behind outsourcing analytical studies.

At both of these major annual events, multiple programming options vie for the attention of attendees.We developed this supplement last year to bring this practical information to our broader BPI print and digital audience.Some of these presentations will be developed into full articles in the months ahead, and if you are especially interested in seeing anything in particular expanded that way, then please let us know.

In just a few months, our publisher and his team will be starting to plan the 2017 theaters.What themes would you find especially compelling, especially for the types of companies and attendees that traditionally attend each of these major, annual events? Are we pretty much succeeding at taking the pulse of this industry, or are there specific areas that you feel we are ignoring? As always, we cannot do this without you!