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Biography

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 filtration, purification, single-use and flexible facility technologies, embracing the related regulations and validation requirements

Abstract

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. Therefore the main aim within the drug development cycle is financial risk mitigation, which often results in outsourcing. The major financial burdens is capital expenses, invested into rigid production facilities, which are often only designed to facilitate one product, are very inflexible in regard to scaling-up and -down, are unable to be divested if the drug target fails and are immovable. The predicament of investment versus financial risk mitigation was a major for start-up companies, but nowadays affect 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 flexibility is becoming a key element, so much that plug and play options are required. The paper will present such plug and play options, production process platforms, which can be employed fast track and with high degree of flexibility. It will scrutinize the options and the feature and benefits 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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