The New Regulatory Environment for Cellular Therapy Products: Challenges for Academic-Based Manufacturing Facilities

  • E. J. Read
Conference paper
Part of the Developments in Hematology and Immunology book series (DIHI, volume 38)

Abstract

Scientific advances in transplantation biology, immunology, and molecular genetics have suggested exciting possibilities for novel cell-based treatments for a variety of malignant and non-malignant diseases. Many of these cellular therapies are already moving from the research bench to the clinic. The development, clinical evaluation, and dissemination of these therapies is largely dependent on the availability of reliable, clinically feasible methods for the procurement, ex vivo manipulation, storage, and administration of human cells and tissues. In academic centers, laboratories engaged in the preparation of cellular therapy products have typically evolved from bone marrow transplant service laboratories, research laboratories, or hospital-based blood transfusion service laboratories. Since 1989, the US Food and Drug Administration (FDA) has published a series of guidance documents and proposed regulations relevant to cellular therapy products. These new expectations have created substantial challenges for manufacturers, especially for academic-based laboratories that support early phase clinical trials not intended to result in a commercial product.

Keywords

Cellular Therapy Early Phase Clinical Trial Current Good Manufacturing Practice Gene Therapy Product Establishment Registration 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Springer Science+Business Media Dordrecht 2003

Authors and Affiliations

  • E. J. Read
    • 1
  1. 1.Department of Transfusion Medicine, Warren G. Magnusen Clinical CenterNational Institutes of HealthBethesdaUSA

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