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Manufacturing of Clinical Grade Cellular Products Under GMP Conditions

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Cell-Based Therapy for Degenerative Retinal Disease

Part of the book series: Stem Cell Biology and Regenerative Medicine ((STEMCELL))

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Abstract

Cellular therapies for retinal diseases have been increasing in numbers and have demonstrated safety and initial efficacy in clinical trials, recently. It is anticipated that some of these therapies will be moved into late stage clinical trials, with potential marketing approval in the near future. In order to safely manufacture such products, first for clinical trials, and then later for potential marketing, larger scale Good Manufacturing Practice (GMP) processes must be developed. In this chapter, we will describe the principles behind GMP manufacturing, the standards set by the United States Food and Drug Administration (FDA), and facilities, materials, and personnel required for such manufacturing. We will also be discussing potential methods for scale-up and how to possibly produce large doses for the treatment of large numbers of patients in the future, after these therapies have been approved as marketed products. Conventional small-scale tissue culture flask based manufacturing methods are compared to manufacturing methods in multilayer cell factories and to a closed system hollow fiber bioreactor, possibly providing an advancement in producing the required numbers of cells. Only with the application of reproducible and reliable large-scale cellular manufacturing methods for allogeneic products will there be enough cell doses available to treat the anticipated number of patients in need of such therapies, and provide them with a clinical benefit.

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Author information

Authors and Affiliations

  1. GMP Facility, Institute for Regenerative Cures, University of California Davis School of Medicine, Sacramento, CA, USA

    Brian Fury & Gerhard Bauer

  2. Gavin Herbert Eye Institute and Stem Cell Research Center, University of California Irvine School of Medicine, Irvine, CA, USA

    Henry Klassen

Authors
  1. Brian Fury
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  2. Henry Klassen
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  3. Gerhard Bauer
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Corresponding author

Correspondence to Gerhard Bauer .

Editor information

Editors and Affiliations

  1. Institute of Ophthalmology and Visual Science, Rutgers New Jersey Medical School, Newark, NJ, USA

    Marco A. Zarbin

  2. Wilmer Eye Institute, Johns Hopkins University, School of Medicine, Baltimore, MD, USA

    Mandeep S. Singh

  3. Department of Surgery School of Medicine & Hospital Clinic of Barcelona, University of Barcelona, Barcelona, Spain

    Ricardo P. Casaroli-Marano

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Fury, B., Klassen, H., Bauer, G. (2019). Manufacturing of Clinical Grade Cellular Products Under GMP Conditions. In: Zarbin, M., Singh, M., Casaroli-Marano, R. (eds) Cell-Based Therapy for Degenerative Retinal Disease . Stem Cell Biology and Regenerative Medicine. Humana Press, Cham. https://doi.org/10.1007/978-3-030-05222-5_5

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