Making an efficient & effective transition to GMP raw materials

Cell & Gene Therapy Insights 2019; 5(2), 239-248.

10.18609/cgti.2019.028

Published: 9 April 2019
Podcast
Udo Nirenberg

Dr Udo Nirenberg

Dr Udo Nirenberg is Vice President of Quality Management at CellGenix, where he is responsible for the quality system of CellGenix and the quality of the products. Udo has more than 25 years experience in the industry in leading positions in Quality Control, Quality Assurance as well as Regulatory Affairs. Udo holds a degree in chemistry and received his Ph.D. in analytical chemistry from the University of Frankfurt/Main, Germany. He started his carreear at Bachem, Switzerland, a leading GMP manufacturerer of peptides. In the following years he took over the responsibilities for quality control, quality assurance and regulatory affairs departments at Bachem affiliates in the United States. Prior to his position at CellGenix, Udo was responsible for quality control testing of biopharmaceuticals under GMP and quality management for more than 10 years at Solvias AG, a globally acting analytical contract laboratory in Switzerland. Quality Management at CellGenix, where he is responsible for the quality system of CellGenix and the quality of the products. Udo has more than 25 years experience in the industry in leading positions in Quality Control, Quality Assurance as well as Regulatory Affairs. Udo holds a degree in chemistry and received his Ph.D. in analytical chemistry from the University of Frankfurt/Main, Germany. He started his carreear at Bachem, Switzerland, a leading GMP manufacturerer of peptides. In the following years he took over the responsibilities for quality control, quality assurance and regulatory affairs departments at Bachem affiliates in the United States. Prior to his position at CellGenix, Udo was responsible for quality control testing of biopharmaceuticals under GMP and quality management for more than 10 years at Solvias AG, a globally acting analytical contract laboratory in Switzerland.

 

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This article is part of the Raw and Starting Materials spotlight