Getting Biopharmaceutical Tech Transfer Right the First Time

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Article
Pharmaceutical TechnologyPharmaceutical Technology-05-15-2017
Volume 2017 eBook
Issue 1
Pages: s36-s42

Good project management, budgeting, planning, and clear documentation are the only ways to prevent overruns and project failure.

Biopharmaceutical experts Stephen Perry, CEO of Kymanox, James Blackwell, principal consultant with The Windshire Group, and consultant Mike Ultee, share best practices and musts to avoid in biopharmaceutical technology transfer. 

Some crucial takeaways?  Share all data (especially data on failed runs in the past), and include clear instructions for sampling.  In addition, aim for reproducibility.

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Clean, Disinfect, and Validate
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Kill the Bioburden, Not the Biological Indicator
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Cold Chain Logistics for Personalized Medicine: Dealing With Complexity
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Ensuring the Biological Integrity of Raw Materials
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Getting Biopharmaceutical Tech Transfer Right the First Time
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Developing an Injectable Compound for a Dual- Chamber Delivery System
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Case Study: Retrofitting Two New High-Purity Water Systems
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Single-Use Bioreactors Have Reached the Big Time
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Parallel Processing
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Cost Considerations Drive Lean Technology in Biomanufacturing
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