Cell therapy clinical trials in Germany – Critical aspects of quality data content: Summary of meeting presentation. Issue 5 (September 2015)

• Record Type: Journal Article
• Authors: Renner, Matthias
• Is Part Of: Biologicals. Volume 43:Issue 5(2015:Sep.)
• Page Start: 429
• Page End: 432
• Publication Date: 2015-09
• Subjects: Regulatory research -- Clinical trials -- Advanced therapy medicinal products -- Cell therapy -- Manufacturing -- Quality; ASCs adipose tissue-derived stromal cells -- ATMPs advanced therapy medicinal products -- CBMPs cell based medicinal products -- EDQM European Directorate for the Quality of Medicines and HealthCare -- EMA European Medicines Agency -- EU European Union -- GCP good clinical practice -- GMP good manufacturing practice -- GTMPs Gene Therapy Medicinal Products -- GvHD Graft-versus-Host Disease -- HSCs hematopoietic stem cells -- IABS International Alliance for Biological Standardization -- IFATS International Federation for Adipose Therapeutics and Science -- IMPs investigational medicinal products -- ISCT International Society for Cell Therapy -- JST Japan Science and Technology Agency -- MAA Marketing Authorisation Application -- MSCs mesenchymal stem or stromal cells -- PEI Paul-Ehrlich-Institut -- RCG WP Working Party on Raw Materials for the production of cellular and gene transfer products; Biological products -- Standards -- Periodicals; Biological Products -- Periodicals; Biological Products -- standards -- Periodicals; Produits biologiques -- Normes -- Périodiques; Biological products -- Standards; Periodicals; 615.37
• DOI: 10.1016/j.biologicals.2015.05.001
• Languages: English
• ISSNs: 1045-1056

Abstract

Abstract: This article is summarizing a presentation given by the author at the International Alliance for Biological Standardization and Japan Science and Technology Agency (IABS-JST) Joint Workshop on "Challenges towards sound scientific regulation of cell therapy products" held at the Kyoto International Conference Center, Kyoto Japan on March 7–8, 2014. The main topics of the presentation were to give a short overview about the regulatory approval process for clinical trials in Germany and to summarize important manufacturing aspects of cell based medicinal products (CBMPs) which are intended to be studied in clinical trials in Germany. Highlights: Critical aspects of Cell-Based Medicinal Product manufacturing are discussed. Clinical trial approval of CBMPs is done on a case by case basis. The EMA risk-based approach is a suitable tool already at early stage CBMP development.