Regulatory considerations in production of a cell therapy medicinal product in Europe to clinical research

Author:

Martín Patricia Gálvez,Martinez Adolfina Ruiz,Lara Visitación Gallardo,Naveros Beatriz Clares

Publisher

Springer Science and Business Media LLC

Subject

General Biochemistry, Genetics and Molecular Biology,General Medicine

Reference35 articles.

1. Mason C, Manzotti E (2009) Regen: the industry responsible for cell-based therapies. Regen Med 4:783–785

2. Committee for Advanced Therapies (CAT) (2010) Challenges with advanced therapy medicinal products and how to meet them. Nat Rev Drug Discov 9:195–201

3. Belardelli F, Rizza P, Moretti F, Carella C, Galli MC, Migliaccio G (2009) Translational research on advanced therapies. Ann Ist Super Sanita 47:72–78

4. Hughes-Wilson W, Mackay D (2007) European approval system for advanced therapies: good news for patients and innovators alike. Regen Med 2:5–6

5. Ottria G, Dallera M, Aresu O, Manniello MA, Parodi B, Spagnolo AM, Cristina ML (2010) Environmental monitoring programme in the cell therapy facility of a research centre: preliminary investigation. J Prev Med Hyg 51:133–138

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