Julia Penk successfully completed her thesis on the topic “Optimizing the upstream process and establishing the downstream sequence for the GMP-compliant biotechnological manufacture of a humanized anti-CD4 IgG4 antibody” in 2017. Through her work, she made a significant contribution towards developing and optimizing a manufacturing process for a therapeutic antibody.

Process development is incredibly important when it comes to translating new findings from pharmacological research into clinical application. This is because defined, scalable manufacturing protocols are required to produce drug candidates quickly and economically for preclinical and phase I and II clinical trials. Optimal process control both in the upstream and downstream areas ensures consistent product quality and guarantees product safety and purity. As part of her thesis, Julia Penk developed the manufacturing process for a novel monoclonal anti-CD4 antibody, which serves as the basis for subsequent pharmaceutical manufacture pursuant to GMP (Good Manufacturing Practice). The preparation is to be used in future to prevent so-called Graft-versus-Host Disease (GvHD) following allogeneic stem cell transplantation procedures.

At Fraunhofer IZI, the optimized process protocols prepared by Julia Penk now form part of standard GMP production for manufacturing clinical test samples for a clinical trial. At the Leipzig-based Fraunhofer institute, the Antibody Production Unit runs a small-scale GMP facility for the pharmaceutical production of monoclonal antibodies. Julia Penk has worked in the unit as bioprocess engineer since completing her thesis.

At Fraunhofer IZI, the thesis was supervised by the Department of Therapy Validation. Julia Penk’s supervisor at the TU Dresden was Professor Thomas Bley, Senior Professor for Bioprocess Engineering at the Institute of Natural Materials Technology. It was Professor Bley who nominated the degree candidate for the award. The award ceremony was held on June 28, 2019, in Hannover.

The Karl Schügerl Award was established in 1995 and is handed out every two years to up-and-coming scientists who have distinguished themselves through their exceptional scientific achievements in the field of biotechnology. It is awarded by the Institute of Technical Chemistry at Leibniz University Hannover, which was directed by Professor Karl Schügerl through to his retirement, as well as university society Leibniz Universitätsgesellschaft Hannover e.V. The award was created in honor of Professor Schürgel’s outstanding scientific achievements as a nationally and internationally recognized expert in the field of biotechnology.