Lurching Toward Personalized Medicine

This year's Interphex conference and exposition just wound down yesterday in New York City.  There had been concerns about show traffic, given the consolidation waves within the industry and their impact on travel budgets, plus the fact that the show started on St. Patrick's Day, infamous for its gridlock. 
It would be difficult to summarize the threads connecting the varied types of equipment and software displayed at the show, but if one were to distill them to a few main themes they would be:

  • flexibility and modularity
  • ease of use for operators (if drug manufacturers aren't working on poka yoke, at least many of their equipment vendors are)
  • ability to move from R&D to manufacturing stages
  • new, or renewed focus on the needs of biopharm manufacturers

Continuous processing was a subtheme, and there was significant interest in process analytical technologies (PAT), which did not receive the hype that PAT has had at previous shows.  One new entrepreneurial company, Sensorin's booth was deluged with visitors. Not so deluged, though, that Paul Thomas didn't get some time with its CEO, Carolyn Kahn (stay tuned for an interview in print and audio format).  The company has introduced a technology that promises to solve a key problem for many biopharm manufacturers, calibrating pH measurements.  Their drift has been the subject of numerous papers at IFPAC and Pittcon in the past.

All of which points to growing awareness of future manufacturing needs and constraints: fast changeover for different products, differing degrees of operator training, and FDA's new definition of process validation.

The conference program was strong.  Among some points:  Carla Reed, senior vice president with Marsh Risk Consulting Group, spoke on anticounterfeiting.  She also appears to have set up her own business, New Creed, LLC.  Catchy name.

I was only able to hear a few presentations:  one by Maxiom Group consultant Fred Greulich on applying FMEA to batch manufacturing, another by Pharmatech President Bikash Chatterjee on using a SIx Sigma approach for process validation.  Mr. Chatterjee will be presenting more on that topic at a webinar we're presenting next week, as will Line Lundsberg Nielsen of NNE Pharmaplan.  Also, a presentation on developing an anticounterfeiting strategy and recognizing weak links in product security, by Scott Dicks of Maxiom Group.  For a link to his presentation, click here.

Paul and Michele Vaccarello Wagner videotaped a number of interviews with technology providers at the show that we're busily posting to the site including: an interview with Emerson VP Jane Lansing on the future of wireless in pharma, interviews with Ahura, which introduced an FTIR handheld to extend its capabilities beyond Raman, Celsis Technologies, and others.  For more, please visit our Interphex link.