Challenges and advantages of cell therapy manufacturing under Good Manufacturing Practices within the hospital setting

Author:

Iancu Emanuela MORCID,Kandalaft Lana E

Funder

Centre Hospitalier Universitaire Vaudois

Publisher

Elsevier BV

Subject

Biomedical Engineering,Bioengineering,Biotechnology

Reference16 articles.

1. REGULATION (EC) No 1394/2007 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004. https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:324:0121:0137:en:PDF.

2. Regulation of advanced therapy medicinal products in Europe and the role of academia;Pearce;Cytotherapy,2014

3. Challenges of running a GMP facility for regenerative medicine in a public hospital;Vigano;Regen Med,2017

4. Delivering cellular and gene therapies to patients: solutions for realizing the potential of the next generation of medicine;Elverum;Gene Ther,2019

5. GMP CAR-T cell production;Gee;Best Pract Res Clin Haematol,2018

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