Dr. Albrecht Gröner

Dr. Albrecht Gröner

Dr. Albrecht Gröner

PathoGuard, Germany

Dr. Albrecht Gröner 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 (i) the safety of the starting material plasma (assessing the epidemiology of blood transmissible viruses in the donor population, establishing screening methods for blood borne viruses in donations in an industrial setting, and releasing plasma pools for fractionation for further processing based on non-reactivity) and cell cultures (testing for endogenous and adventitious viruses in cell cultures and unprocessed bulk), (ii) validation of the down-scaling of manufacturing processes to a laboratory scale for virus clearance studies and testing the capacity of the manufacturing process to inactivate and remove pathogens based on virus validation and prion evaluation studies, and (iii) risk assessments and risk mitigation measures to ensure pathogen safe finished biologicals. Furthermore, (iv) assessing the impact of the integration of new or modified manufacturing steps or equipment on the quality and safety of finished products.

He is member of several scientific societies and in the organisation committee of scientific meetings. Furthermore, he peer-reviews manuscripts related to pathogen safety, testing, and production of biopharmaceuticals submitted for publication.

Viral Safety for Biological Drug Products

with Dr. Albrecht Gröner


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