{"product_id":"from-process-understanding-to-process-control-von-mathieu-streefland","title":"From Process Understanding to Process Control","description":"\u003cp\u003eA licensed pharmaceutical process is required to be  executed within the validated ranges throughout the  lifetime of product manufacturing. Changes to the  process usually require the manufacturer to  demonstrate that the safety and efficacy of the  product remains unchanged. Recent changes in the  regulations for pharmaceutical processing allow  broader ranges of process settings to be submitted  for regulatory approval, when a manufacturer can  scientifically support the rationale for these  settings. The combined validated ranges of settings  for process parameters constitute the so called  process design space. In this thesis, the  applicability of this concept of the process design  space is investigated for the cultivation process  step for a vaccine against whooping cough disease.  This thesis demonstrates that the general principles  of PAT and process design space are general and can  even be applied to an undefined biological product  such as a whole cell vaccine.\u003c\/p\u003e\u003cdiv class=\"aw-variant-hidden-subtitle-div\" id=\"aw-variant-subtitle-9783838361314\"\u003e\u003ch3\u003eApplication of PAT ont he cultivation of Bordetella pertussis for a whole cell vaccine\u003c\/h3\u003e\u003c\/div\u003e","brand":"Autorenwelt Shop","offers":[{"title":"Softcover - 9783838361314","offer_id":39499094523997,"sku":"9783838361314","price":68.0,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0940\/0622\/files\/e498eb98-893f-44fe-b064-ff409eaba051.jpg?v=1759211109","url":"https:\/\/shop.autorenwelt.de\/products\/from-process-understanding-to-process-control-von-mathieu-streefland","provider":"Autorenwelt Shop","version":"1.0","type":"link"}