Getting Biopharmaceutical Tech Transfer Right the First Time

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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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Pharmaceutical Technology’s 2017 Biologics and Sterile Drug Manufacturing eBook

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Articles in this issue
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Clean, Disinfect, and Validate
Bioburden_225-1.jpg
Kill the Bioburden, Not the Biological Indicator
Cryoport_225.jpg
Cold Chain Logistics for Personalized Medicine: Dealing With Complexity
RawMaterials_225.jpg
Ensuring the Biological Integrity of Raw Materials
TechTransfer_225.jpg
Getting Biopharmaceutical Tech Transfer Right the First Time
Vetter_225.jpg
Developing an Injectable Compound for a Dual- Chamber Delivery System
GSK_225.jpg
Case Study: Retrofitting Two New High-Purity Water Systems
SUBioreactors_225.jpg
Single-Use Bioreactors Have Reached the Big Time
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Parallel Processing
Biosims_225.jpg
Cost Considerations Drive Lean Technology in Biomanufacturing
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