Integrierte Isolatortechnologie zur Herstellung von zellbasierten Arzneimitteln unter Sterilbedingungen Jürgen Norwig a, Olivera Josmovic-Alasevic b, Karl-Gerd Fritsch b, Katja Steiof b und Vilma Siodla b Norwig GmbH a, Kandern und Ziesar, und co.don® AG b, Teltow Integrated Isolator Technology Based Sterile Production of Cell Based Drugs Final sterilisation of various pharmaceutical products - so also of autologous cell transplants - often is not possible, since they are thermolabile. Hence the requirements for sterile production of such preparations are of very high standard of working condition.
Production using conventional cleanroom technology, e.g. under laminar flow benches, is sometimes supplying insufficient results, since contaminations are easily possible due to frequent direct or undirect contact between product and operator.
On the base of this experience “Integrated Isolator Technology (IIT)” has been developed. The novelty of IIT is the direct full integration of the complete necessary equipment i.e. incubators, centrifuge, microscope, deep-cooler, cooler and any other item for production, microbiology or specific analytical purposes in the isolator.
Advantage of the chosen handling possibility is the permanent connection between isolator and working area (class D) due to VHP-sterilizable material locker equipment. The risk of secondary contamination is strongly minimized and the product safety is on highest level.
Isolator and combined apparatus are equipped with permanent fully automatic monitoring and alarm systems for all relevant parameters corresponding to EU- and FDA-standard/guidelines.
With this technology the current “state of the art” for isolator technology is defined. Key Words Autologe Zelltransplantate · Biologische Arzneimittel · Isolator · Integrierte Isolatortechnologie · Sterile Arzneimittel · Zell-basierte Arzneimittel |
