Cell Biology: Research & TherapyISSN: 2324-9293

Review Article, Cell Biol Res Ther Vol: 3 Issue: 1

General Requirement for Quality and Safety in Stem Cell and Cell-Based Products for Translational Therapy

Sandra Regina Barroso Ruiz Sella1,2, Julio Cesar Francisco3, Tânia Mara Madalozzo3, Ana Carolina Irioda3, Bassam Felipe Morghabel3, Reginaldo Justino Ferreira1,4, Luiz Cesar Guarita- Souza5 and Katherine Athayde Teixeira de Carvalho1,3*
1Bioprocess Engineering and Biotechnology Department, Federal University of Paraná, Av, Curitiba, Paraná, Brazil
2Production and Research Center of Immunobiological Products, Paraná State Department of Health, Piraquara, Paraná, Brazil
3Cell Therapy and Biotechnology in Regenerative Medicine Department, The Pelé Pequeno Príncipe Institute, Child and Adolescent Health Research, Pequeno Príncipe Faculty, Curitiba, Paraná, Brazil
4Federal University of Technology, Curitiba, Paraná, Brazil
5Experimental Laboratory of Institute of Biological and Health Sciences of Pontifical Catholic University of Parana (PUCPR), Rua Imaculada Conceição, Curitiba, Paraná, Brazil
Corresponding author : Katherine Athayde Teixeira de Carvalho
Cell Therapy and Biotechnology in Regenerative Medicine Department, The Pelé Pequeno Príncipe Institute, Child and Adolescent Health Research, Pequeno Príncipe Faculty, Av. Silva Jardim 1632, Box 80.250-200, Curitiba, Paraná, Brazil
Tel: 55 04133101719
E-mail: [email protected]
Received: January 03, 2014 Accepted: February 07, 2014 Published: February 12, 2014
Citation: Sella SRBR, Francisco JC, Madalozzo TM, Irioda AC, Morghabel BF et al. (2014) General Requirement for Quality and Safety in Stem Cell and Cell-Based Products for Translational Therapy. Cell Biol: Res Ther 3:1. doi:10.4172/2324-9293.1000108

Abstract

Cells and tissues for transplantation constitute a specific class of health products with important therapeutic value, as they have in many cases no equivalent in restoring life-supporting or essential functions. There are many sources of regulations, rules, and guidance regarding the good tissue practices.Good manufacturing practice (GMP) quality, defined by both the European Medicines Agency and the Food andDrug Administration, is a requirement for clinical-grade cells, offering optimal defined quality and safety in cell transplantation.

Keywords: Cell-based products; Quality; Requirements; Safety; Stem cell; Translation therapy

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