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Advances in Large-Scale Biopharmaceutical Manufacturing
and Scale-Up Production*, 2nd Edition

    Disposable Technologies for Manufacturing of Biologics


    After their introduction into biopharmaceutical manufacturing in the 1990s bioprocess containers disposable technologies have been steadily gaining ground in the industry. Integration of filtration components with storage containers via use of aseptic connection techniques allowed the creation of pre-sterilized out-of-the-box systems which have been increasingly used for various bioprocessing functions, including cell culture, recovery, clarification and purification. The growing popularity of single use systems among API manufacturers is based primarily on the need for sterilization in place (SIP) and cleaning, associated sterilization and cleaning validation as well as virtually complete elimination of product cross-contamination risk. Other advantages of using disposable technologies include added flexibility and shorter benchto- market times, especially for start-up drug development companies or for new products in cases of established manufacturing organizations. Disposables carry certain limitations, such as lower structural strength, relatively high per unit cost and an additional burden of having to decontaminate and dispose of solid plastic waste. The switch to disposables in a GMP organization must follow change control and requires validation of the newly introduced systems (both disposable and non-disposable support components). In addition, plastic systems need to be assessed for the nature and quantities of leachable components which can be extracted into intermediates or the product during routine bioprocessing.

    About the Authors

    Vladimir Kostyukovsky, Biomanufacturing Training and Education Center (BTEC), NC State University, Raleigh, NC
    Vladimir Kostyukovsky currently works as Director of Site Operations, Biotechnology Training and Education Center (BTEC), affiliated with NCSU, Raleigh, NC. His responsibilities include assisting in the design, construction, commissioning and a start-up of the BTEC facility, as well as managing the staff of engineers, bioprocessing technicians, and maintenance personnel for routine operations of the facility. He is also contributing to curriculum design, especially as applies to biologics Process Development and cGMP Manufacturing. Before joining BTEC, Dr. Kostyukovsky worked as Director of Bioprocessing with Biolex, Inc. in Pittsboro, NC, where he managed GMP and pre-clinical material manufacturing operations for a number of therapeutic proteins in transgenic plant system. Prior to Biolex, he worked for Bioreliance Corporation (currently Invitrogen) as Senior Director, Bulk Manufacturing, managing upstream and purification operations for Contract Manufacturing of viral vaccines and vectors, cell and viral banking. Before Bioreliance, Dr. Kostyukovsky served as Associate Director, Cell Culture with Diosynth (RTP), as Head, Cell Culture and Fermentation at DSM Biologics, Montreal, Scale-up Scientist at Apotex Fermentation, Inc. in Winnepeg, MB, developed and scaled-up recombinant protein processes at Allelix Biopharmaceuticals, Toronto, ON. Before joining the Industry, Dr. Kostyukovsky worked for a number of Research Organizations in Russia, Czech Republic and Japan. He received Masters in Animal Science from Ryazan School of Agriculture, Russia, and Ph.D. in Microbiology from Institute of Biochemistry and Physiology of Microorganisms, Russian Academy of Sciences.

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