உயிரணு உயிரியல்: ஆராய்ச்சி மற்றும் சிகிச்சை

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

Sandra Regina Barroso Ruiz Sella, Julio Cesar Francisco, Tania Mara Madalozzo, Ana Carolina Irioda, Bassam Felipe Morghabe, Reginaldo Justino Ferreira, Luiz Cesar Gu

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.