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Transforming Downstream Processing through Multi-Column Chromatography

  • Posted by kmihlbachler
  • On March 6, 2017
The call for implementing continuous processing in the manufacturing of bio-pharmaceuticals requires re-thinking of process chromatography and its equipment design. Proof-of-concepts of innovative multi-column continuous processes were introduced by the industry, which verified improvements in resin utilization and increased productivity [1]. Now, these concepts are transferred and verified at the pilot and production scale. First […]
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FDA To Leverage EU Inspections of European Production Sites

  • Posted by jwillard
  • On March 6, 2017
Regulators in the European Union and the United States have agreed to recognize inspections of manufacturing sites for human medicines performed by the other agency. Each year, authorities from the EU and the FDA inspect the same production sites in the US and EU. Under the new agreement, EU and US regulators will rely on […]
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YP Meet-Up: No Shoes, No RSVP, No Problem!

  • Posted by Kevin Keating
  • On March 3, 2017
Well, maybe shoes would be a good idea after all. But steel toes are optional! The Young Professionals are moving to a new model for social/networking events: the informal meetup. In an effort to supplement our regular networking events, we would like to create a platform for small, after-work meetups to pop up more frequently, […]
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USP Updates Informational Chapter on Pharmaceutical Water

  • Posted by Joseph Manfredi
  • On March 2, 2017
For those who have an interest in pharmaceutical waters, the recently released USP 39 Supplement 2 includes an updated Informational Chapter <1231>. This new and improved chapter has been rewritten and reorganized including a new table of contents, added hyperlinks for contemporization and ease of use, clear and concise technical explanations, and additional material including […]
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Career Development – How to Get Started

  • Posted by sprice
  • On March 1, 2017
Career development in the biotech/pharma industry is very exciting and full of opportunities.  One reason is because the industry has many facets to it – it attracts scientists, doctors and engineers, as well as business professionals in sales, marketing and general administration.  The other reason is because many people in the biotech/pharma industry are energetic […]
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Welcome to Our New Blog, Your Portal for News About the Chapter and Our Industry

  • Posted by John Spohn
  • On February 22, 2017
As your Chapter President, I’m thrilled to welcome you to the brand new ISPE Boston Area Chapter BLOG. The BLOG will be the principal portal for news and information of interest to Members of the Chapter and all Pharmaceutical Professionals in Greater New England. Please bear with us as we strive to grow the BLOG […]
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All Strikes for Young Professionals at Sacco’s Bowl Haven

  • Posted by Kevin Keating
  • On February 22, 2017
The Young Professionals bowling event at Sacco’s Bowl Haven (Flatbread’s Pizza) in Somerville was a big hit for the fourth year in a row. An enthusiastic group of 28 young professionals and students turned out for a night of candlepin bowling, delicious pizza and an opportunity to make new connections. The YPs represented a wide […]
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Massachusetts Joins Institute for Innovation in Biopharm Manufacturing

  • Posted by jwillard
  • On February 21, 2017
Massachusetts will be a partner in the nation’s first manufacturing innovation institute in biopharmaceutical manufacturing. The $250 million biopharmaceutical innovation institute is a national, public-private partnership, with federal matching funds provided by the US Department of Commerce’s National Institute of Standards and Technology. Massachusetts will anchor the northeastern node for the institute, which will be […]
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Broad Institute CRISPR Patents Upheld

  • Posted by jwillard
  • On February 16, 2017
Broad Institute has announced that the patents granted to MIT, Harvard and Broad Institute concerning CRISPR editing of eukaryotic genomes do not interfere with patent claims filed by UC Berkeley and the University of Vienna, according to a decision handed down by the U.S. Patent Trial and Appeal Board on February 15. The decision confirms […]
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Devens’ BMS Integrates New Capabilities in an Existing Plant & Wins ISPE Facility Integration Award

  • Posted by jwillard
  • On February 16, 2017
The Bristol-Myers Squibb (BMS) campus at Devens is part of the company’s Global Manufacturing Network. The two newest facilities, the Biologics Development Building (BDB) and the Clinical Manufacturing Building (CMB), recently earned BMS the ISPE Facility of the Year (FOYA) Facility Integration Award. The new facilities were designed and built in an efficient manner and […]
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