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AiChE Boston Presents “Fundamentals of Bulk Solids Handling” on Saturday, April 29

  • Posted by ispeblog
  • On April 5, 2017
If you work with powders or other bulk solids and are interested in learning how to design bulk solid handling systems, this workshop is for you! Systems for handling powders and other bulk solids are often improperly designed, leading to: Erratic flow, no flow or limited throughputs Poor product quality and excessive downtime Customer complaints Safety issues including […]
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Single Use Manufacturing & the Impact on Process, Facility Design & Procurement

  • Posted by jwillard
  • On April 3, 2017
Single use technology opens up a world of possibilities never considered before for biotech/pharma manufacturing but also brings with it a host of new challenges. As companies move from simple application of single use systems like bags (for buffer storage) to more complex single use systems and even entire single use facilities, the potential impact […]
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Is Continuous Manufacturing in Your Future?

  • Posted by Dan Pratt
  • On March 29, 2017
Is continuous manufacturing in your future? After all, the technology to enable continuous manufacturing of biopharmaceuticals is rapidly being developed. After attending the Chapter’s educational program at Takeda Pharmaceuticals on March 16, my conclusion is that continuous manufacturing is definitely in our future but, as with past transformations in technology, adoption by industry will be […]
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Best Practices for Sampling of Pharmaceutical Water: New ISPE Good Practice Guide

  • Posted by Joseph Manfredi
  • On March 15, 2017
Sampling of pharmaceutical water is a required activity that has historically relied on the expertise of those responsible for developing and implementing the sampling procedures and/or plan. Sampling provides proof that a system producing water for pharmaceutical applications is operating under control and that the water being used is of suitable quality for the intended […]
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Continuous Biopharmaceutical Manufacturing – Possible, Improbable, or Unavoidable?

  • Posted by Andre Walker
  • On March 6, 2017
I don’t remember a lot of effort going into learning about batch processing in my chemical engineering studies.  Continuous processing was the norm in refineries and many chemical plants.  Steady state equated to even quality, and output could be tuned for maximum efficiency.  The world revolved around a well understood material balance.  Batch was for […]
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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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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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Pharmaceutical Water and Steam: Important Updates on the State-of-the-Art

  • Posted by Brian Hagopian
  • On February 3, 2017
The pharma and biotech industries spend millions of dollars annually in costly investigations into alert, action, and out of specification excursions related to the critical utilities of water and steam. These expenditures could be greatly minimized if the issues and challenges related to sampling were clearly understood. To address this knowledge gap, ISPE has introduced […]
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Industry Leaders Discuss “Quality by Design” at Chapter’s Regulatory Symposium

  • Posted by mbraatz
  • On February 2, 2017
Industry leaders Bert Frohlich, Director of Strategy and Technology Lifecycle, Shire, and Amy Lachapelle, Lead Consultant & Founder, QbD Strategies, presented “Quality by Design” as part of the Chapter’s recent Regulatory Symposium held at Northeastern University. Well known in the regulatory field with a combined 38+ years of experience in biopharmaceutical manufacturing, the speakers presented […]
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