Validation of analytical methods in GMP: the disposable Fast Read 102® device, an alternative practical approach for cell counting

Author:

Gunetti Monica,Castiglia Sara,Rustichelli Deborah,Mareschi Katia,Sanavio Fiorella,Muraro Michela,Signorino Elena,Castello Laura,Ferrero Ivana,Fagioli Franca

Publisher

Springer Science and Business Media LLC

Subject

General Biochemistry, Genetics and Molecular Biology,General Medicine

Reference25 articles.

1. Committee for Human Medicinal Products (CHMP): Guidelines on Human Cell-Based Medicinal Products. European Medicines Agency, Doc. Ref. EMEA/CHMP/410869/2006

2. European Parliament and Council Directive. 2001, /83/EC of 2001/83/EC of 6th November 2001 on the community code relating to medicinal products for human use,

3. European Parliament and Council Directive. 2004, /23/EC of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells,

4. Italian Parliament Legislative decree N. 191/2007 of the to adopt EC Directive. 2004, /23/EC,

5. European Parliament and of the Council Regulation (EC) N. 1394, /2007 of 13 November 2007 on advanced therapy medicinal products,

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