Journal of Bioequivalence & Bioavailability

Cell therapy regulations - a critical factor in translational medicine

International Conference and Exhibiton on Pharmaceutical Regulatory Affairs

6-7 September 2011 Baltimore, USA

Beate Wagner and Reinhard Henschler

Scientific Tracks Abstracts: JBB

Abstract:

T he current state of cell therapy regulations in Europe is presented from the perspective of a manufacturer in a university hospital who also is a member of the hospital ́s recently founded Interdisciplinary Centre of Cell Th erapy (IZZTKUM). An overview of Good Manufacturing Practice (GMP) and other standards will be given, focusing on the manufacture of sterile medicinal products in a class 100 (A) cleanroom. Links to the application of these products in clinical trials according to Good Clinical Practice (GCP) will be identifi ed. Measures for quality assurance such as accreditation are considered useful tools to demonstrate compliance with laws and regulations. Recent developments in cell therapy ? specifi cally the Advanced Th erapy Medicinal Products (ATMPs) - have prompted a cascade of new regulations which will be outlined. Conversely the latter have challenged current methods and concepts such as testing product identity or sterility aft er culture and other manipulation procedures. Th e large spectrum of methods required for manufacturing and quality control of ATMPs results in the involvement of other partners and the need of written agreements. Coping with all these standards and regulations remains critical in the implementation of new options in cell therapy

Biography :

Beate Wagner earned her doctoral degree from Ruprecht Karls University of Heidelberg. She is a specialist in internal medicine and transfusion medicine and works as Senior Consultant and laboratory director in the Department of Transfusion Medicine & Hemostaseology, University Hospitals of Munich. At 2 sites she implemented cleanroom operation and sterile manufacture, which she is the Quali fi ed Person of. She also is a member of the hospital ́s recently founded Interdisciplinary Centre of Cell Therapy (IZZT KUM )