HomeVideoMaik W Jornitz | G-Con Manufacturing Inc | USA | Parenterals 2015 | Conference Series LLC

Maik W Jornitz | G-Con Manufacturing Inc | USA | Parenterals 2015 | Conference Series LLC

International Conference and Expo onParenterals & Injectables, August 17-19, 2015 Chicago, USA

Scientific Talk On: The review of fl exible production platforms for pharma/biopharmaceutical processing
Click here for Abstract and Biography: http://parenterals-injectables.pharmaceuticalconferences.com/abstract/2015/the-review-of-fl-exible-production-platforms-for-pharma-biopharmaceutical-processing

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Maik W Jornitz is a former PDA Board member (Chair of the Board of Directors) and currently a member of the PDA Science Advisory Board (SAB), Audit Committee and co-chair of the Aging Facility Task Force. He is also member of ISPE, ASTM, ASME, a multitude of editorial advisory boards, Science Advisory Board of Artemes and Biotechnology Industry Council. As a faculty member of various training organizations, especially PDA TRI, he trains industry and regulators on a frequent basis. Maik has close to 30 years’ experience in fi ltration, purifi cation, single-use and fl exible facility technologies, embracing the related regulations and validation requirements
A major question arising in drug development, is it better to invest or to outsource, when to invest and how to ramp up production capacity? All these questions are posted with the uncertainty whether the drug target will be successful or not. Th erefore the main aim within the drug development cycle is fi nancial risk mitigation, which oft en results in outsourcing. Th e major fi nancial burdens is capital expenses, invested into rigid production facilities, which are oft en only designed to facilitate one product, are very infl exible in regard to scaling-up and -down, are unable to be divested if the drug target fails and are immovable. Th e predicament of investment versus fi nancial risk mitigation was a major for start-up companies, but nowadays aff ect as much large biopharma. Furthermore, the product portfolio of the industry is changing from large volume multi-patient treatments to low volume individual patient treatment. Production site design fl exibility is becoming a key element, so much that plug and play options are required. Th e paper will present such plug and play options, production process platforms, which can be employed fast track and with high degree of fl exibility. It will scrutinize the options and the feature and benefi ts of new modular designs, which can be assembled to entire processes or kept as unit operation. Example cases of such modular site designs will be exposed

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