Good Manufacturing Practice–compliant change of raw material in the manufacturing process of a clinically used advanced therapy medicinal product–a comparability study-Reference-Cited by-同舟云学术

Good Manufacturing Practice–compliant change of raw material in the manufacturing process of a clinically used advanced therapy medicinal product–a comparability study

Published:2023-05 Issue:5 Volume:25 Page:548-558
ISSN:1465-3249
Container-title:Cytotherapy
language:en
Short-container-title:Cytotherapy

Author:

Wixmerten Anke,Miot Sylvie,Bittorf Patrick^ORCID,Wolf Francine,Feliciano Sandra,Hackenberg Stephan,Häusner Sebastian^ORCID,Krenger Werner,Haug Martin,Martin Ivan^ORCID,Pullig Oliver,Barbero Andrea^ORCID

Publisher

Elsevier BV

Subject

Cancer Research,Transplantation,Cell Biology,Genetics (clinical),Oncology,Immunology,Immunology and Allergy

Reference40 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, E. PARLIAMENT, Editor. 2007: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32007R1394&from=EN.

2. Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products, E. Commission, Editor. 2017.

3. Guide to Good Manufacturing Practice for medicinal products annexes. Annex 2A Manufacture of advanced therapy medicinal products for human use, P.I.C.-O. SCHEME, Editor. 2022: https://picscheme.org/docview/4590.

4. European Pharmacopeia chapter 5.2.12. Raw materials of biological origin for the production of cell-based and gene therapy medicinal products., E.D.f.t.Q.o.M.H. (EDQM), Editor. 2022: https://www.edqm.eu/en/european-pharmacopoeia.

5. 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, E. Commission, Editor. 2001: https://eur-lex.europa.eu/homepage.html.

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