July 2010, Volume XX, No. 4
 

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Acceleron Facility Tour and Single-Use Technology Draw Overflow Crowd to Cambridge

by Keyur Doshi with photos by Viriya Shloul, both of Acceleron Pharma

They came, they saw, they learned! There is no better way to describe the level of enthusiasm exhibited by the sheer number of people who took part in the Single-Use Technology Seminar and Facility Tour at Acceleron Pharma in Cambridge on May 11th.
Chapter Member and Meeting Manager Keyur Doshi (r)
of Acceleron led one of the groups that toured
the Acceleron facility.

The evening began with a Members-only tour of the Acceleron Pharma Clinical Manufacturing Facility. This was a unique opportunity for Chapter Members to view first-hand some of the interesting approaches taken by Acceleron in its early phase, clinical GMP facility.

Following the tour, the evening's first speaker - Acceleron Senior VP of Manufacturing Bob Steininger - provided great insight into the company's pilot and GMP manufacturing strategy and how the concept of a disposable facility complements that strategy. He described the design basis of the disposable aspect of the facility which incorporates some interesting concepts like no purified water or steam system...something unheard of only a few short years ago.

A standing room only crowd listened attentively as a
series of speakers discussed various aspects of
single-use manufacturing technology.
In the second talk of the evening, speakers Paul Slaman of Shire HGT and industry consultant James Vogel provided an overview of Shire's implementation of single-use systems at their Lexington facility. The core topics they discussed were Shire's single-use business processes which include material selection, process evaluation and material/process comparison. They also emphasized a critical factor in such assessments: a successful owner-vendor partnership.

The third and final talk of the evening by Xcellerex President and CEO Parrish Galliher was extremely informative as he reviewed the current state of industrial research in new technologies for single-use manufacturing, especially downstream processing. Some technologies, such as single-pass ultrafiltration and pre-packed chromatography, looked very promising and have already generated a lot of curiosity. Others, like simulated moving-bed chromatography and expanded-bed chromatography, though still in their nascent stage, have demonstrated significant savings - in case studies at least.

We need to thank everyone who made this event a success, not least of all the many Boston Area Chapter professionals (over 100) who turned out for the event and took part in a lively discussion on single-use systems. Beyond a doubt, this event was a huge success and managed to generate a lot of excitement among Chapter Members, demonstrating the high level of interest in this area of technology.




 

Chapter Manager: Amy Poole, CAMI - Tel: 1.781.647.4773 and E-mail: ispe@camihq.com
 
   
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