The Fraunhofer USA Center Mid-Atlantic Biotechnology Division is focused on working with partners and clients to solve problems and overcome roadblocks on the path to developing novel technologies in the bio space and progressing target molecules to the clinic and market. Scientific staff at the Division have expertise in molecular biology, protein biochemistry, immunology, virology, microbiology and plant biology. In addition to research laboratories, the Division houses a pilot plant facility with GMP production capability and associated quality control and quality assurance functions. Staff at the Division have experience of managing large research programs with Government and nonprofit partners as well as smaller projects with biotechnology companies, and guiding lead targets through preclinical development and early phase clinical trials including preparing documentation for IND submissions. The Division has four main competence areas:
- Molecular design and formulation of vaccine candidates. The Division has engineered virus-like particles for vaccine candidates with improved immunogenicity and efficacy, and has developed spray dried formulations of lead vaccine candidates with improved thermostability and controlled release characteristics.
- Production of recombinant proteins with vaccine, therapeutic and diagnostic applications in novel heterologous expression platforms, including scaling to pilot scale. The Division has experience in developing, optimizing and scaling alternative production platforms for biologics.
- Metabolic engineering of biosynthetic pathways in cell culture systems for the production of natural products. The Division has engineered cell cultures for the production of secondary metabolites, optimized growth conditions and scaled up production processes.
- Generation and screening of microbial libraries and isolation of previously uncultured microbes with novel activities. The Division has developed quorum sensing/quenching technology to culture and identify novel microorganisms and screen them for antimicrobial activities that have been advanced into preclinical development. This approach is also applicable to identifying novel enzymes.