Adventitious agents’ safety, Virus safety of blood products and recombinant proteins, Safety of human and animal derived materials, TSE safety
Dr. Albrecht Gröner is founder and managing director of PathoGuard Consult, supporting companies manufacturingbiopharmaceuticals or medical devicesfrom or with human or animal derived starting or raw material regarding the assessment of pathogen safety. He is an internationally renowned expert in pathogen safety of biologicals with more than 40 years of experience in virology.
Dr. Gröner worked for more than 30 years in the field of pathogen safety of biologicals prepared from plasma or cell cultures as Head of Pathogen Safety at CSL Behring and predecessor companies (Behringwerke, Centeon, Aventis Behring, ZLB Behring) focusing on
- 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),
- freedom of cell cultures for biotechnological products and vaccines (adventitious viruses in cell lines and unprocessed bulk) and quantification of retroviruses/retrovirus-like particles,
- 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,
- virus and TSE safety of animal derived raw materials
- 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 removepotentially present prions and demonstrating the inactivation capacity of cleaning/sanitisation procedures regarding viruses and prions
- risk assessments and risk mitigation measures to ensure pathogen safe finished biologicals and medical devices.
He published numerous articles related to the area of expertise, gives invited talks and presentations at conferences and at diverse regulatory agencies within and outside Europe. He was member of the German Advisory Committee Blood (Arbeitskreis Blut; term of three years from 2012 to 2015) and the respective subgroups ‘Overall Blood Supply Strategy with Regard to Variant Creutzfeldt-Jakob Disease (vCJD)’ (2008 to 2009) and ‘Convalescent Plasma’ (2013 to 2014) and is member of the subgroup ‘Assessment of Pathogens Transmissible by Blood’ (from 2005 until present) and is member of several scientific societies and organising committees of scientific conferences. He established and headed a certified GLP facility for virus validation studies.
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.