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This article describes the numerous activities in the commercial quality control (QC) network that aim to replace in vivo assays with alternative methods in the course of production and release.1
Sven M. Deutschmann, PhD
Roche Diagnostics GmbH
Head of Global ASAT Adventitious Agents Testing & Alternative Microbiological Me
Sven Deutschmann studied biology at the University of Brunswick where he obtained his PhD in cell culture technology. In 1995 he joined Roche Diagnostics GmbH. His current position is Head of Global Analytical Science and Technology “Adventitious Agents Testing & Alternative Microbiological Methods” within Global QC. In this role he is responsible for the Adventitious Agent Control Concept and the evaluation, validation and implementation of alternative microbiological methods into the Microbial Control Concept.<br/>
Besides his global responsibilities he is involved in External Interaction. Sven Deutschmann is member of the German Pharmacopeia Commission, the Microbiology Committee and the Working Party “Pyrogentests” of the German Pharmacopeia Commission as well as Germany’s representative in the Working Party “Bacterial Endotoxins”, and chairman of the “Mycoplasmas” and Expert Group 1 “Biological Methods and Statistical Analysis” of the European Pharmacopeia Commissions in Strasbourg, France. In 2009 he was appointed as commissioner of the Central Commission for Biological Safety, a brains trust of the Federal Office of Consumer Protection and Food Safety. In addition, he is member of PDA Task Forces resp. co-author of PDA-Technical Reports (TR #50, TR #69, draft version of TR “Post Approval Change Management for Biologics and Pharmaceutical Drug Products") and chairman of the Advisory Board of the ECA “Pharmaceutical Microbiology” Interest Group.
Besides his global responsibilities he is involved in External Interaction. Sven Deutschmann is member of the German Pharmacopeia Commission, the Microbiology Committee and the Working Party “Pyrogentests” of the German Pharmacopeia Commission as well as Germany’s representative in the Working Party “Bacterial Endotoxins”, and chairman of the “Mycoplasmas” and Expert Group 1 “Biological Methods and Statistical Analysis” of the European Pharmacopeia Commissions in Strasbourg, France. In 2009 he was appointed as commissioner of the Central Commission for Biological Safety, a brains trust of the Federal Office of Consumer Protection and Food Safety. In addition, he is member of PDA Task Forces resp. co-author of PDA-Technical Reports (TR #50, TR #69, draft version of TR “Post Approval Change Management for Biologics and Pharmaceutical Drug Products") and chairman of the Advisory Board of the ECA “Pharmaceutical Microbiology” Interest Group.
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