Advanced therapy medicinal products-A multiple challenge

Transfusion Medicine and Hemotherapy

Volumn 40, Issue 6, 2013, Pages 384-385

  Pruss, Axel ^a   Garritsen, Henk ^b  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b Institute of Clinical Transfusion Medicine Hospital Braunschweig GGmbH   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

HERBACEOUS AGENT; GENE THERAPY AGENT; MOLECULAR THERAPY AGENT;

DRUG INDUSTRY; EDITORIAL; EUROPEAN UNION; BONE REGENERATION; CARTILAGE TRANSPLANTATION; CELL CULTURE; CELL DIFFERENTIATION; CELL REGENERATION; CELL THERAPY; CELL TRANSPLANTATION; DRUG CLASSIFICATION; DRUG EFFICACY; DRUG LEGISLATION; DRUG QUALITY; DRUG SAFETY; DRUG USE; EUROPEAN MEDICINES AGENCY; HUMAN; MESENCHYMAL STROMA CELL; TISSUE ENGINEERING; TISSUE REGENERATION; TRANSFUSION MEDICINE;

EID: 84896528656     PISSN: 16603796     EISSN: 16603818     Source Type: Journal    
DOI: 10.1159/000357305     Document Type: Editorial

References (13)

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. Official Journal of the European Union, L 324, 121.
2. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. Official Journal of the European Union, L 311/67.
3. Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Official Journal of the European Union, L 136/1.
4. Flory E, Reinhardt J: European regulatory tools for advanced therapy medicinal products. Transfus Med Hemother 2013;40(6):409-412.
5. Smith M, Brune J, Wildemann B, Pruss A: Whither advanced therapy medicinal products. Transfus Med Hemother 2013;40(6):449-452.
6. Witzeneder K, Lindenmair A, Gabriel C, Höller K, Theiß D, Redl H, Hennerbichler S: Human-derived alternatives to fetal bovine serum in cell culture. Transfus Med Hemother 2013;40(6):417-423.
7. Kemptner J, Witzeneder K, Hennerbichler S, Gabriel C: Proteomic analysis of human derived cell culture supplements. Transfus Med Hemother 2013;40(6):413-415.
8. Gill ON, Spencer Y, Richard-Loendt A, Kelly C, Dabaghian R, Boyes L, Linehan J, Simmons M, Webb P, Bellerby P, Andrews N, Hilton DA, Ironside JW, Beck J, Poulter M, Mead S, Brandner S: Prevalent abnormal prion protein in human appendixes after bovine spongiform encephalopathy epizootic: large scale survey. BMJ. 2013;347:f5675.
9. Krüger JP, Freymann U, Vetterlein S, Neumann K, Endres M, Kaps C: Bioactive factors in plateletrich plasma obtained by apheresis. Transfus Med Hemother 2013;40(6):432-440.
10. Kadow-Romacker A, Duda G, Bormann N, Schmidmaier G, Wildemann B: Slight changes in the mechanical stimulation affects osteoblast-and osteoclast-like cells in co-culture. Transfus Med Hemother 2013;40(6):441-447.
11. Von Roth P, Winkler T, Rechenbach K, Radojewski P, Perka C, Duda G: Improvement of contraction force in injured skeletal muscle after autologous mesenchymal stroma cell transplantation is accompanied by slow to fast fiber type shift. Transfus Med Hemother 2013;40(6):425-430.
12. Wieczorek A, Uharek L: Genetically modified T cells for the treatment of malignant disease. Transfus Med Hemother 2013;40(6):388-402.
13. Kalus U, Wilkemeyer I, Pruss A, Caspari G: Validation of serological testing for anti-Treponema pallidum from postmortem blood on the Siemens-BEP-III Automatic System. Transfus Med Hemother 2013;40(6):403-408.