Titlebook: Cell Therapy; cGMP Facilities and Adrian P. Gee Book 2022Latest edition Springer Nature Switzerland AG 2022 cell processing facilities.cel

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Selection of Contract Manufacturing and Testing Organizationsd-alone hospital, wishes to build a cell processing facility to provide the products. An alternative is to use commercial companies for cell processing and/or testing. In recent years, a number of such entities have appeared, and this chapter addresses some of the factors that are involved in select

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R. W. H. Sargent,G. R. Sullivanstent and suitable quality while complying with the legal requirements and regulatory frameworks. New technologies and manufacturing models are emerging to overcome these hurdles and enable scalable and cost-efficient production. In the following sections of this chapter, several aspects with respec

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K. Iracki,K. Malanowski,S. Walukiewicze severe. The knowledge of Food and Drug Administration (FDA) regulations is vital for every researcher; this chapter highlights the regulatory knowledge that is essential to perform successful leading-edge research. Any investigator who is interested in conducting GLP studies must perform a needs a