Single-Use vs. Stainless: Experts Weigh In…

By | December 15, 2017

By Bill Garvey and Howard Sneider: Single-use technology has exploded onto the scene in the last two decades to offer a practical alternative to costly stainless steel process systems. But will single-use systems render a mature and reliable technology eventually obsolete? This outcome is unlikely as a large group of ISPE members and other industry… Read More »

FDA Approves First Short-Acting “Follow-On” Insulin Product

By | December 14, 2017

The FDA has granted approval to Sanofi-Aventis U.S. for Admelog, a short-acting insulin product. Admelog is the first short-acting insulin approved as a “follow-on” product and was submitted through the agency’s 505(b)(2) abbreviated approval pathway. A new drug application submitted through this pathway may rely on the FDA’s finding that a previously approved drug is… Read More »

Chapter Member Anniversaries: November 2017

By | December 6, 2017

Please congratulate the following members celebrating milestone anniversaries in November 2017.  Their dedication to ISPE, the Boston Area Chapter and the industry is applauded! Over Twenty Years Charles H. Brown, II, MS James R. Dube, Associate Director, Technology Transfer, Global Technical Services, Alexion Pharmaceuticals Thomas G. Larkin, Jr., Sr Project Engineering Manager, Amgen Inc Pasquale… Read More »

Welcome New Members!

By | December 6, 2017

We would like to introduce the members who joined ISPE in November 2017, welcome them to the Chapter and encourage them (and all of our members) to take advantage of the many professional development, networking and information resources available through ISPE. Fellow ISPE members are a terrific resource for help with everyday professional challenges.  And… Read More »

Foundation Medicine Wins FDA Approval for Breakthrough Cancer Test

By | December 5, 2017

The FDA has approved the FoundationOne CDx (or F1CDx), a breakthrough cancer diagnostic test developed by Cambridge-based biotech Foundation Medicine. F1CDx detects gene mutations that may be found in any solid tumor. This information can be used by physicians to manage cancer patients. Moreover, it can be used as a companion diagnostic to identify patients… Read More »

Chapter Members Learn “How to Deal with Difficult People”

By | November 30, 2017

In contrast to the typical technically-focused educational events, the Boston Area Chapter’s November educational program – “How to Deal with Difficult People” presented by Amber Galou, Stephanie Fedak, and Bruce Sohmer – was a chance for attendees to shift their focus to “soft skills” that effect every aspect of life in the workplace.  The speakers… Read More »

Call for Presentations: Product Show 2018

By | November 28, 2017

The ISPE Boston Area Chapter will hold its 27th Annual Product Show on September 26, 2018 at Gillette Stadium in Foxborough, MA. This notice is a call for presentations for a limited number of speaking opportunities. Our charter is to deliver valuable educational programs to our members and their guests, based on specific topics of interest… Read More »

Stainless Steel and Single Use – More Similar than You Think…

By | November 27, 2017

Over the past 20 years, the benefits and detriments of single use technologies for the manufacturing of biologics have been stated by proponents and detractors throughout the industry. Some issues are well defined (capital investment) while other topics lack clarity. This post will address a couple of often misunderstood facets of stainless steel and single… Read More »