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ADVANCES & NEW FRONTIERS IN STERILE MANUFACTURING TECHNOLOGY

17th & 18th April 2020, Mumbai, India

High potency a p i production

PRESENTATION BY RICHARD DENK

 More than 700 Bio Pharmaceutical Products right now in pre-clinical and clinical studies which are considered as high potent. Many of them will come to the market the next few years. What requirements are needed to prevent cross contamination in shared facilities. 

  

Richard Denk is working at the company SKAN AG, headquartered in Allschwil in the position Senior Consultant Aseptic Processing & Containment. 

Richard founded 11 years ago the Containment expert group of the ISPE D / A / CH. The Containment Group published the Containment Manual Richard was responsible for in September 2015. 

Richard is member of the PDA Isolator Expert Group and publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to Personnel and Patient”. 

Richard Denk is chapter leader for the new ISPE Baseline Guide for ATMPs. 

Furthermore, Richard is Member of the ISO TC 198 WG-9 Aseptic Isolator Group. 

Richard has spent more than 20 years with the subject production of highly active / highly hazardous substances and has developed the containment pyramid. 

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