Biopharmaceuticals:
Development, manufacturing
and analytics

Scientific-Regulatory Expert & Assessor Biomedicines; Jörg Engelbergs holds a doctorate in biology with a focus on cell biology and biotechnology and has held various positions in the field of experimental cancer research as a research group leader, including at the West German Tumour Centre WTZE. He currently works for the Paul Ehrlich Institute, Federal Institute for Vaccines and Biomedicines, as a scientific-regulatory expert and reviewer in the areas of pharmaceutical quality, non-clinical and personalised medicine in the context of the entire life cycle of biopharmaceuticals. Furthermore, as a product-specific expert, he accompanies national GMP inspections and those carried out in third countries (USA/Asia) and is a member of various European regulatory working groups such as the "European Directorate for the Quality of Medicines & HealthCare" (EDQM; Host-Cell Protein Working Party, P4Bio/Biosimilar Working Party) and the "European Medicines Agency" (EMA; Methodology Working Party, CDx Consultation Working Party).

Josef Gabelsberger studied biology and biotechnology at the Technical University of Munich, where he gained his doctorate in microbiology. He then worked for a total of 15 years, first at the Munich Gene Centre and then at a medium-sized biotech company in Munich in the field of process development for the production of therapeutic vaccines and oncolytic viruses. Since 2006, he has been employed at Roche Diagnostics GmbH in Penzberg, where he led the technical fermentation development of monoclonal antibodies for over a decade. Since 2020, Josef Gabelsberger has been Technical Development Manager of a gene therapy project.

Associate Director/Senior Group Leader Dr Monika Geiger completed her studies in pharmacy at the Philipps University in Marburg in 1997. She received her licence to practise in 1997. Until 2015 she was Senior/Principal Scientist at Pfizer. She then joined Lonza AG in Switzerland as Senior Principal Scientist and Principal Group Leader, Formulation Development, Drug Product Services. She has held her current position since 2022.

Sonja Matt has been working as a scientific assessor at the Paul-Ehrlich-Institut since 2016 and evaluates the pharmaceutical quality of monoclonal and polyclonal antibodies. Between 2018 and 2020, she participated in and successfully completed the Master's programme "Drug Regulatory Affairs" at the University of Bonn.

Anika Schröter holds a PhD in toxicology and is a registered European Registered Toxicologist. Since 2014 she has been working as a consultant for clients in the pharmaceutical and biotech industry on issues related to non-clinical drug development (e.g. small molecules, biologics, vaccines). Her expertise includes the creation of non-clinical development programs, design and supervision of GLP toxicology studies, or support in consultations with European or non-European authorities. Since 2021 she runs her own consulting company in Vienna.

Vice President Preclinical Research Matthias Germer has been Head of Preclinical Research at Biotest AG since 1999 and is responsible for the non-clinical parts of study submissions and product approvals for biotherapeutic and biological drugs in the EU, the USA and other countries. Since then he has been an expert in analytics under GMP and GCLP, pharmacology, toxicology and pharmacokinetics. As head of the testing facility, he is responsible for the organization and functioning according to GLP principles. He shares his know-how in numerous congresses, lectures and seminars .