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Advanced Therapies: Clinical, Non-clinical and Quality Considerations

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Abstract

Cell therapy, tissue engineering, and gene therapy products, together called “advanced therapy medicinal products” (ATMPs), represent a heterogeneous group of innovative biopharmaceuticals. ATMPs are based on viable cells, tissue, or genetic material. In this chapter, after a brief introduction, first different classification systems of these products are discussed, illustrated with representative examples of products in clinical development or commercially available. Next, the challenges associated with successful pharmaceutical development, manufacturing, and testing of these products are covered. Finally, regulatory aspects are dealt with.

Parts of this chapter were taken from the fourth edition chapter 25 authored by Colin W. Pouton.

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Suggested Reading

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Authors and Affiliations

  1. Leiden University Medical Center, Hospital Pharmacy, Interdivisional GMP Facility, Leiden, The Netherlands

    Karin H. Hoogendoorn

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  1. Karin H. Hoogendoorn
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Correspondence to Karin H. Hoogendoorn .

Editor information

Editors and Affiliations

  1. Utrecht University, Utrecht, The Netherlands

    Daan J. A. Crommelin

  2. Faculty of Pharmaceutical Sciences and The Centre for Health Evaluation & Outcomes Sciences (CHEOS), The University of British Columbia (UBC), Vancouver, BC, Canada

    Robert D. Sindelar

  3. College of Pharmacy, University of Tennessee, Health Science Center, Memphis, TN, USA

    Bernd Meibohm

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Hoogendoorn, K.H. (2019). Advanced Therapies: Clinical, Non-clinical and Quality Considerations. In: Crommelin, D., Sindelar, R., Meibohm, B. (eds) Pharmaceutical Biotechnology. Springer, Cham. https://doi.org/10.1007/978-3-030-00710-2_17

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