A particular focus of the working group Biological Processing and Infrastructure is the establishment and the application of viral pseudovirus systems and infectious reporter virus systems, e. g. for HIV-1. In this context, a global bank for HIV-1 pseudoviruses and infectious HIV-1 reporter clones was established within the global initiative for the development of an HIV vaccine ("Collaboration for AIDS Vaccine Discovery - CAVD"; Bill & Melina Gates Foundation), which contains several hundred different viral stocks.
For worldwide use in vaccine studies, the production and quality control of viral stocks at the Fraunhofer IBMT is subject to a certified quality assurance program according to the guidelines of the "Good Clinical Laboratory Practice" (GCLP). In order to expand the portfolio of virus systems, the working group Biological Processing and Infrastructure deals with the establishment and application of SARS-CoV-2 pseudovirus reporter systems. Thereby, the working group provides a platform for development and clinical testing of vaccines and new antiviral therapies. In the laboratory and cryostorage area available at the Fraunhofer IBMT, virological or other biological or genetic engineering operations and questions up to safety level S3 or S3** can be performed or processed.
Beyond the GCLP-compliant production and application of pseudoviruses, the working group Biological Processing and Infrastructure deals with the implementation of various quality management systems and standards. It offers a diverse range of services in the development of cell-based assays, which are validated up to certification under a suitable QM system, the performance of in vitro biocompatibility studies in accordance with DIN EN ISO 10933-5 for the approval of medical devices or the performance of studies in accordance with the guidelines of "Good Laboratory Practice" (GLP).
Furthermore, induced pluripotent stem cells for the "European Bank for induced pluripotent Stem Cell (EBiSC)" are expanded, characterized and quality controlled according to DIN EN ISO9001:2015 by means of flow cytometry and RT-qPCR-based gene expression analysis, among others.
Likewise, the working group holds the expertise to establish and implement application-specific workflows in forward-looking mobile laboratory units. The working group was involved in the validation of a pooling procedure for PCR-based SARS-CoV-2 diagnostics in a mobile laboratory platform. Based on the experience gained there, further mobile so-called "all-in-one laboratory platforms" for nucleic acid-based detection of SARS-CoV-2 were developed and implemented. In addition to the mobile laboratory platforms, a quality management system for laboratory medical examinations in accordance with the RiLiBÄK for use in mobile laboratory units and a WEB-based portal for registration, sample administration and result transmission were also established.
- Working with cells, microorganisms and clinical samples up to BSL-3
- Establishment of biobanks (including cryopreservation, storage and distribution/shipment)
- Establishment and application of pseudovirus and reporter virus systems
- Antiviral drug efficacy studies
- Determination of immune responses (cellular and antibody-based)
- Development and automation of cell-based assays and process flows (QM-compliant)
- Optimization and validation of biological processes and procedures (QM-compliant)
- Establishment of cell cultures, cell expansion, cell characterization, cell quality control, gene expression analyses
- Biocompatibility studies
- Implementation of quality assurance programs and establishment of standard operation procedures (SOP)