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Dr. Albrecht Groner

Consultant, Freelancer

Dr. Albrecht Groner is consultant for the biotherapeutic industry having worked for more than 30 years in the field of pathogen safety of biologicals prepared from plasma or cell cultures focusing on

1. virus safety of the starting material human plasma for plasma derived medicinal products (epidemiology in the donor population regarding blood-borne viruses, screening of donations and releasing plasma pools for fractionation for further processing based on non-reactivity).

2. freedom of cell cultures for biotechnological products and vaccines (adventitious viruses in cell lines and unprocessed bulk) and quantification of retroviruses/retrovirus-like particles.

3. Detection methods for the agent causing transmissible spongiform encephalopathy (TSE, especially (v)CJD), the prion protein, and assessing the potential presence of prions in human and animal derived starting and raw material.

4. Designing and performing appropriate virus validation studies and prion evaluation studies, based on a validated down-scaled laboratory scale of the manufacturing process, to assess the capacity of the manufacturing process to inactivate and remove relevant viruses and to remove potentially present prions and demonstrating the inactivation capacity of cleaning/sanitisation procedures regarding viruses and prions.

5. Virus and TSE safety of animal derived raw materials.

6. Risk assessments and risk mitigation measures to ensure pathogen safe finished biologicals and medical devices.

Dr. Gröner received his degree in biology and his PhD (Dr. rer. nat.) from the University of Tübingen (Germany) and was lecturer at the universities of Tübingen and Mainz.

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