Tuesday, September 2, 2014

Analytical and Quality in biopharmaceutical manufacturing

Today, we feature the suite of Analytical and Quality podcasts that BioProcess International Magazine has conducted with speakers leading up to the BioProcess Intenrational Conference and Exhibition taking place October 20-23.  The Analytical and Quality tracks will be taking place Tuesday, October 21-Thursday, October 23 and will feature presentations from Genentech, Roche Diagnostics, ImClone Systems and more.

Here are three interviews we conducted with speakers in preperation for this track:
  • Strategies and Challenges of Establishing an Analytical Control Strategy for Complex Biomolecules
  • -By Johnson Varghese, Senior Director and Head of the Analytical Development Group, Shire
  • >In this podcast, Johnson discusses the establishing critically of product attributes, the difference in analytics between monoclonal antibodies and complex molecules, and the current state is of in-vitro bioassays for measuring product quality.

  • Strategies for Continued Process Monitoring of Commercial Cell Culture and Purification at Large Scale
  • -By Pawel Drapala, Senior Process Engineer, Technical Manufacturing Services, Alexion Pharmaceuticals
  • >The importance of continuous process modeling in a highly regulated market, the tools and equipment are you using for process monitoring of large-scale monoclonal antibodies manufacturing, important process parameters are in terms of quality assurance and more.

  • Microbial Control: What’s Bugging You?
  • -By Sarah Thomas, Site Quality Director, GlaxoSmithKline
  • >In this podcast, Thomas discusses the microbial contamination and the increased amount of oversite, the potential avenues are for microbial contamination in the biopharmaceutical manufacturing environment, the types of process monitoring tools can be used to detect microbial contamination and more.

BioProcess International Conference and Exhibition will take place October 20-23, 2014 in Boston, MA.  As a reader of this blog, when you register to join us and mention code BPI14BLOG, you can save 20% off the standard rate.

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