New project applies enGenes -e^xpress to biosimilars

Vienna, Austria: – Recombinant protein specialist manufacturer enGenes Biotech GmbH (enGenes) has announced a new collaboration with the Technical University of Vienna (TU Wien) to apply the company’s proprietary enGenes-e^Xpress™ technology to integrative bioprocess development for biosimilar production.

The project, funded by the Wiener Wirtschaftsagentur (Vienna Business Agency), has considerable implications for biosimilars companies, holding out the prospect of decreased manufacturing costs for complex molecules, reduced time-to-market and diminished development risks. The mid-term goal is to provide cell lines and manufacturing processes with certified quality parameters such as biological activity in bioassays or comparative biosimilarity to originator.

enGenes-e^Xpress – a cutting edge bacterial production platform

Prospects for achieving these aims largely rest on the -e^Xpress E. coli platform’s proven ability to achieve outstanding yields of soluble and active recombinant protein, radically improving on the existing T7 expression system. The technology is fully scaleable and can be operated at high cell densities (up to 80-100 g/L biomass), allowing high specific and volumetric yields.

enGenes-e^Xpress technology has already unlocked successful manufacture of enzymes and biopharmaceutical products that failed to give economically feasible yields in conventional expression hosts, such as BL21(DE3).

“We believe this project will be of great interest to biosimilar manufacturers looking for ways to create the cheapest possible characterization and development program to achieve price competitiveness in the market without losing valuable time,” said Asst. Prof. Dr. Oliver Spadiut, Head of the Research Group for Integrated Bioprocess Development at TU Wien.

enGenes R&D strengths

The collaboration emphasizes enGenes’ strengths in Research & Development (R&D) and its vision of developing a world-class portfolio of cutting-edge protein production technologies, relevant to a broad spectrum of application fields.

“We are not only a company that is out licensing technology; we do a lot of research and we drive innovation to offer really the best technologies and services to our clients,” said enGenes Biotech CEO, Dr. Juergen Mairhofer.

“This project provides us with the opportunity to determine mechanistic correlations between fermentation parameters and final biosimilar quality. Knowing these correlations is of high value since this allows us to manufacture high quality molecules like antibody fragments with high yields in less time within a pre-defined quality target range and therefore allows to significantly decrease time-to-market,” said Dr. Mairhofer.

Focus on innovation

Driving innovation is a core business activity for enGenes, which is participating in several other projects supported by the Austrian Research Promotion Agency (FFG), or international funding bodies like the European Union.

The company is also part of the H2020 Rafts4Biotech project (www.rafts4biotech.eu), a project that builds upon the discovery of bacterial lipid rafts to exploit them as a biotechnological tool for spatial confinement of reactions of industrial interest.

“We work with the best people in the field and we are very open to collaborative projects,” said Dr. Mairhofer.

“We shape our activities in biosimilars to make ourselves ideal partners for people working in the field, being able to provide advanced process development to complement the work of companies with expertise in drug development and biosimilars, looking to produce those molecules with reasonable and economically feasible yields,” he added.

About enGenes Biotech

enGenes Biotech GmbH (enGenes) is a contract research, development and manufacturing company that provides leading edge technologies and production services focused on recombinant proteins in bacteria. The company’s mission is to provide cost-effective and scalable production of recombinant proteins at a fraction of current cost, allied to a vision of developing a world-class portfolio of cutting-edge protein production technologies, relevant to a broad spectrum of application fields.

enGenes has developed advanced technologies to drive more cost effective recombinant protein production processes., including its proprietary enGenes-e^Xpress™ E. coli platform that achieves outstanding yields of soluble and active recombinant protein. enGenes-e^Xpress has been successful applied for the manufacturing of enzymes and biopharmaceutical products that failed to give economically feasible yields in a conventional expression host.

enGenes Biotech offers development and manufacturing services tailored around the needs of pharmaceutical and industrial biotech companies. The services include expression strain and vector development, fermentation process development and optimization, downstream process development, production of purified protein, technology transfer and scale-up support with technology out-licensing and co-development opportunities.