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Addressing the Manufacturing Challenges of Cell-Based Therapies

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Book cover Current Applications of Pharmaceutical Biotechnology

Part of the book series: Advances in Biochemical Engineering/Biotechnology ((ABE,volume 171))

Abstract

Exciting developments in the cell therapy field over the last decades have led to an increasing number of clinical trials and the first cell products receiving marketing authorization. In spite of substantial progress in the field, manufacturing of cell-based therapies presents multiple challenges that need to be addressed in order to assure the development of safe, efficacious, and cost-effective cell therapies.

The manufacturing process of cell-based therapies generally requires tissue collection, cell isolation, culture and expansion (upstream processing), cell harvest, separation and purification (downstream processing), and, finally, product formulation and storage. Each one of these stages presents significant challenges that have been the focus of study over the years, leading to innovative and groundbreaking technological advances, as discussed throughout this chapter.

Delivery of cell-based therapies relies on defining product targets while controlling process variable impact on cellular features. Moreover, commercial viability is a critical issue that has had damaging consequences for some therapies. Implementation of cost-effectiveness measures facilitates healthy process development, potentially being able to influence end product pricing.

Although cell-based therapies represent a new level in bioprocessing complexity in every manufacturing stage, they also show unprecedented levels of therapeutic potential, already radically changing the landscape of medical care.

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Author notes

  1. Authors “Miguel de Almeida Fuzeta and André Dargen de Matos Branco” contributed equally.

Authors and Affiliations

  1. Department of Bioengineering and iBB-Institute for Bioengineering and Biosciences, Instituto Superior Técnico, Universidade de Lisboa, Lisboa, Portugal

    Miguel de Almeida Fuzeta, André Dargen de Matos Branco, Ana Fernandes-Platzgummer, Cláudia Lobato da Silva & Joaquim M. S. Cabral

Authors
  1. Miguel de Almeida Fuzeta
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  2. André Dargen de Matos Branco
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  3. Ana Fernandes-Platzgummer
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  4. Cláudia Lobato da Silva
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  5. Joaquim M. S. Cabral
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Corresponding author

Correspondence to Cláudia Lobato da Silva .

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Editors and Affiliations

  1. UCIBIO, REQUIMTE, MEDTECH, Laboratory of Pharmaceutical Technology, Department of Drug Sciences, Faculty of Pharmacy, University of Porto, Porto, Portugal

    Ana Catarina Silva

  2. FP-ENAS (UFP Energy, Environment and Health Research Unit), CEBIMED (Biomedical Research Centre), Faculty of Health Sciences, Fernando Pessoa University, Porto, Portugal

    Ana Catarina Silva

  3. Center for Neurosciences and Cell Biology (CNC) and Faculty of Pharmacy (FFUC), University of Coimbra, Coimbra, Portugal

    João Nuno Moreira

  4. UCIBIO, REQUIMTE, MEDTECH, Laboratory of Pharmaceutical Technology, Department of Drug Sciences, Faculty of Pharmacy, University of Porto, Porto, Portugal

    José Manuel Sousa Lobo

  5. UCIBIO, REQUIMTE, MEDTECH, Laboratory of Pharmaceutical Technology, Department of Drug Sciences, Faculty of Pharmacy, University of Porto, Porto, Portugal

    Hugo Almeida

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de Almeida Fuzeta, M., de Matos Branco, A.D., Fernandes-Platzgummer, A., da Silva, C.L., Cabral, J.M.S. (2019). Addressing the Manufacturing Challenges of Cell-Based Therapies. In: Silva, A.C., Moreira, J.N., Lobo, J.M.S., Almeida, H. (eds) Current Applications of Pharmaceutical Biotechnology. Advances in Biochemical Engineering/Biotechnology, vol 171. Springer, Cham. https://doi.org/10.1007/10_2019_118

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