Fraunhofer Institute for Molecular Biology and Applied Ecology IME
The Fraunhofer Institute for Molecular Biology and Applied Ecology IME is addressing different research areas in the field of applied life sciences, reaching from the molecular level towards complex ecosystems. The production and characterization of recombinant proteins using a large panel of different expression systems, including microbial systems, eukaryotic cells, as well as plants and plant suspension cells, is one of the IMEs main areas of expertise. The institute has more than 20 years of experience in the production of pharmaceutically relevant proteins of different types, covering vaccine candidates, cytokines, antibody fragments and full-length antibodies. These activities are being performed in the context of several public or industry-funded R&D projects, and the in house GMP-facility has been used for process development and production of clinical trial material in different expression systems, including E.coli, Pichia pastoris and transgenic tobacco plants.
Role in the TRANSVAC project
The Fraunhofer IME leads the Transnational Access 1 (TNA1) "Cross platform screening and optimization service“ and the corresponding Joint Research Activity (JRA1) "Improved optimization and harmonization of cross-vector screening“ both aiming at the provision of comprehensive range of different well established pro- and eukaryotic expression/production systems to identify the optimal manufacturing platform for any given vaccine candidate. Within the Joint Research Activity (JRA3) Assay development and validation, Fraunhofer will work on the development and standardization of SPR-methods required during vaccine research and development as well as production and quality control, and on the development of impurity-related assays required for product characterization. In the context of the "European Training Programme in Vaccinology“ Fraunhofer IME will provide three different Training Modules including Assay Development and Validation, focused on SPR technology, Process Development and scale up, as well as on Requirements for GMP-production.
Main staff involved in TRANSVAC
Holger Spiegel; Dr. Jürgen Drossard; Dr. Johannes Buyel.
In addition to “state of the art” multipurpose S1 and S2 laboratory facilities, the Fraunhofer IME features a 100 m2 non-GMP process development laboratory with 5-30L stainless steel fermentation capacity. Additional cultivation systems including disposable systems from microtiter to 100L scale are available for general R&D and process development purposes. The GMP-production facility comprises two production suites with cleanroom classes D and C. One of the suites is designed for mammalian cell culture processes in that it has separate class C DSP rooms (pre/post virus inactivation). The upstream capacity is two trains of 15, 100 and 350 L working volume stainless steel bioreactors. Recovery and DSP equipment match the upstream capacity. Additionally the facility comprises greenhouse space as well as phytochambers for plant cultivation. Besides the whole range of standard technology for the purification and detailed characterization of biomolecules the facility is equipped with a molecular Interaction analysis suite including a GxP validated Biacore T200 SPR instrument.
TNA or Training provided
The Transnational Access 1 (TNA1) "Cross platform screening and optimization service“ and the corresponding Joint Research Activity (JRA1) "Improved optimization and harmonization of cross-vector screening“ will combine the expertise of six different partners (IME, SSI, UOXF, iBET, BPRC and UNISI) to provide the unique offer to test vaccine candidates in a comprehensive range of different expression hosts, to identify the optimal production system for further pre-clinical and clinical development. The development of SOPs and the implementation of standardized procedures wherever possible will enable the generation of reliable data on protein yields and quality to provide valid decision criteria on the choice of expression system. Within the "European Training Programme in Vaccinology“ Fraunhofer IME will provide two-day Training Modules focusing on three different topics. The module “Assay Development and Validation” will provide an insight into “state of the art” applications of SPR-technology in the context of vaccine development. Besides the detailed analysis of antibody responses, the training will address the development and validation of quality control and quantification assays. The training module “Process Development and scale up”, will give a deeper insight into the topic by discussing “real life” scenarios. Based on the experiences with several GMP-production processes, the module “Requirements for GMP-production” will improve the perception of essential prerequisites that have to be taken into account before heading for the “GMP” adventure.