Dr. Elena Meurer
Elena has a track record of 9 years in diverse leading positions in the biopharmaceutical industry.
Elena is a biologist by training and obtained her doctoral degree at the Ludwig Maximillian University of Munich, Germany. After several years of postdoctoral research, Elena joined apceth Biopharma GmbH, where she contributed to the development and manufacturing of various Advanced Therapy Medicinal Products (ATMP) based on native as well as genetically modified human cells. She was holding positions of Head of Quality Control, Head of Translational Sciences and Head of Pharmaceutical and Technical Development.
As Head of Quality Control, she was responsible for GMP- and CMC-based aspects of ATMP manufacturing and release. Her expertise comprises establishment of quality control strategies for products developed in the same organisation as well as within the scope of contract manufacturing; qualification and validation of quality control methods, as well as the transfer of quality control methods to different manufacturing sites. She participated in the establishment of a quality control laboratory as well as in the preparation of several manufacturing license applications.
As Head of Pharmaceutical and Technical Development, Elena’s responsibility was CMC development and translation of R&D products into the GMP-compliant status. She was also involved in the strategic planning of product development (including upscale strategies for ATMPs) and technology transfers. Elena contributed to compilation of regulatory quality documentation and participated in scientific advises at PEI.
The combination of these two roles enabled Elena not only to collect extensive experience in the ATMP field, but also to access the biopharmaceutical issues from two different standpoints, as a developer and as a manufacturer.
Elena was giving invited talks at national and international conferences and is an author of several publications related to the above field.
At Biopharma Excellence, Elena has further expanded her expertise to questions related to medical devices of different classes and combination products.
Elena provides scientific as well as regulatory and strategic expertise in CMC and device related issues.