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Pharmaceutical Technology
Pharmaceutical Technology-05-15-2017Volume2017 eBook Issue 1
Pages: s36-s42
Getting Biopharmaceutical Tech Transfer Right the First Time
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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
Kill the Bioburden, Not the Biological Indicator
Cold Chain Logistics for Personalized Medicine: Dealing With Complexity
Ensuring the Biological Integrity of Raw Materials
Getting Biopharmaceutical Tech Transfer Right the First Time
Developing an Injectable Compound for a Dual- Chamber Delivery System
Case Study: Retrofitting Two New High-Purity Water Systems
Single-Use Bioreactors Have Reached the Big Time
Parallel Processing
Cost Considerations Drive Lean Technology in Biomanufacturing
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