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Featured Image

Try Your Hand at Regenerative Manufacturing May 18-19

  • Posted by Russell Carr
  • On April 25, 2018
Several Chapter members attended the NH High Tech Council event about Biotech/Medtech in Manchester, NH on April 5.  Dean Kamen and others from the Advanced Regenerative Manufacturing Institute (ARMI) presented their vision of the future of tissue engineering.  ARMI is charged with bringing tissue engineered products to market and is involved with product development, manufacturing […]
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Learn About Genomics and Epigenetics & Save!

  • Posted by ISPE Boston
  • On April 25, 2018
No current medical development raises so many opportunities – ranging from cancer treatment, to degenerative disease, to aging itself. To learn more, join the Medical Development Group (MDG) on Monday, April 30 at Regis College Fine Arts Center in Weston, MA for their program “Genomics and epi-Genetics – Impact on Developments in Medicine and Society.” […]
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Chapter Members: Local ISPE Training at a Discount Just for You

  • Posted by ISPE Boston
  • On April 19, 2018
Take advantage of a rare opportunity – four full days of ISPE biopharma training in the Boston area May 7-10 plus a 20 percent discount for members of the Boston Area Chapter!  Enjoy specialized, in-depth classroom trainings from leading industry experts in seven critical areas: Biopharmaceutical Manufacturing Facility Design and Processes, GAMP® 5 Basic Principles […]
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XaaS: Adapting Your Validation Approach for a Service-Providing Vendor

  • Posted by Jimmy Hughes
  • On April 2, 2018
As more life sciences companies are founded on the use of contract research, development and manufacturing organizations, the need to communicate and manage thousands of records and tens of GxP processes across the globe via cloud-hosted software infrastructure continues to grow.  Cloud services (SaaS, PaaS, IaaS, etc.) offer numerous benefits for life sciences companies but […]
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Life Sciences Pose Challenge for Local Real Estate Developers

  • Posted by Robert Lucas
  • On March 5, 2018
The life science sector in Massachusetts continues to grow rapidly and with a high degree of technological advancement and innovation. This growth and innovation continues to challenge those key stakeholders in the real estate sector of the life science industry who are striving to better enable the effective and efficient delivery of products to patients. […]
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No Paper? No Problem! Lessons Learned Implementing Electronic Documentation

  • Posted by Kevin Keating
  • On February 5, 2018
A critical aspect of any cGMP activity is documentation. As the old saying goes, “If it wasn’t written down, it didn’t happen.” But even as so many forms of communication have become electronic, paper-based documentation systems are still common among pharmaceutical companies. The simplicity of paper-based systems is seemingly obvious: all you need is a […]
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Keeping Up-to-Date with Biotech Automation at Takeda

  • Posted by mbraatz
  • On January 24, 2018
Technology is changing the face of the industry and people need to jump on the train or get left behind. With that in mind, no wonder “The Future of Biotech Automation” attracted almost 100 ISPE members and guests to Takeda in Cambridge on January 18 where two experts in the field brought their topic to […]
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Back to the Future of Biotech Automation

  • Posted by rpierro
  • On January 3, 2018
What’s currently happening in automation and where are we going? Will batching be gone forever in favor of single-use components in a continuous process? Will we be wearing Google glasses and following instructions from some brainy robot with our heads in the electronic cloud? The biotech industry has benefited enormously over the past 30 years […]
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Single-Use vs. Stainless: Experts Weigh In…

  • Posted by ISPE Boston
  • On 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 […]
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Stainless Steel and Single Use – More Similar than You Think…

  • Posted by Howard Sneider
  • On 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 […]
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