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European Biopharmaceutical Review

Fast Track Project Implementation: Risk or Reward?

New technology products, particularly those with a long regulatory approval time, often come under extreme pressure in the industrialisation stage - taking the product from bench or small scale up to full manufacturing scale. Key to success are project definition, risk management, effective teamwork and supply chains, and controlled handover and validation.

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By Gareth Davies, Operations Director at CEL International

Gareth Davies is Operations Director with CEL International in Coventry. A Chemist by training, Gareth has a process operational background and over 15 years' experience in projects ranging from 1/2 million to 140 million and in diverse applications from biotechnology through pharmaceuticals and food production to man-made fibres and chemicals. A core member of the recent task group sponsored by the Department of Trade and Industry to define best practice for fast track projects, Gareth led CEL's teams on the 2001 and 2002 ACTIVE 'Project of the Year' projects, the latter having been won against pan-European competition.

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Gareth Davies
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WuXi STA and Dizal Pharmaceutical Sign CMC Development and Manufacturing Agreement

STA Pharmaceutical Co., Ltd., (WuXi STA) a subsidiary of WuXi AppTec and Dizal Pharmaceutical, a biotechnology company, announce a strategic partnership. Under the terms of the collaboration, WuXi STA will become the preferred CDMO partner of Dizal Pharmaceutical for GMP production, providing integrated CMC (Chemical, manufacturing and Control) process research and manufacturing services from API to drug product.
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12th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology

23-26 March 2020, Vienna, Austria

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