Efficient, cost saving, extremely innovative
The Austrian life science scene covers the whole range of biopharmaceutical upstream and downstream processing, from process monitoring and control to biomaterials processing, and even to plant engineering. There are global players like Baxter, whose activities include the development and production of blood plasma compounds, recombinant coagulation factors, fibrin sealants and vaccines such as the FSME vaccine or Boehringer Ingelheim, which runs centres for oncological research and for biopharmaceutical development and production of innovative drugs in Vienna. Sandoz, the specialist for “difficultto-make-products“ and biosimilars, develops and produces in Kundl, Tyrol.
But there are also a large number of younger Austrian enterprises that have found their way to the international market. The development of biotechnology is encouraged by a favourable tax regime for corporates and the plentiful availability of local funding opportunities, including sources such as Austria Wirtschaftsservice (aws) and the Austrian Research Promotion Agency (FFG) as well as local funding for start-ups.
A number of Austrian start-ups have discovered their niche in subcontract work for other enterprises: Polymun, e.g., founded in 1992 by Hermann Katinger, concentrates on the development and production of biopharmaceuticals and liposomal formulations. It is currently carrying out a project for ProNAi, a US company, to produce a liposomally formulated, DNA interference-based therapy for certain kinds of cancer. ProNAi received the go-ahead from the FDA for a clinical Phase I study in March this year, not least because of Polymun’s expertise in liposome technology.
Both the time scale for drug development as well as the excessive costs will be significantly reduced by innovative technologies developed in Austria.
Producing drugs more cost effectively
Drug development costs are exploding, while the number of new therapeutic agents reaching the market continues to fall. Thus, the key to the future is the improved ability to predict the efficacy and side-effects of potential treatments. In addition, there exist enormous challenges in product development and production – now more than ever.
The new Research Centre for Pharmaceutical Engineering (RCPE) is one of the first research centres in Europe to tackle these recent developments based on scientific approach. RCPE’s vision is to speed up product development and to cut costs, thereby making development and production more efficient, effective and economical.
RCPE aims to replace empirical approaches of drug production by rational methods. Both the time scale for drug development (now up to 12 years) as well as the excessive costs (up to 1–2 billion Euro per drug) will be significantly reduced. Research will focus on systematic product- and process development strategies, quality management (QbD), on the synthesis of structured materials, as well as on process scale-up, optimization and control strategies (PAT).
Among RCPE’s research partners are Roche Diagnostics, GL Pharma, Fresenius Kabi Austria, VTU, Merck, Sandoz Austria, Boehringer Ingelheim Austria, Zeta, Hecus and many more. 13 institutes from the following universities are taking part: Graz University of Technology, Joanneum Research, University of Graz (Karl-Franzens-Universität) and the Austrian Academy of Sciences (ÖAW). RCPE is owned by Graz University of Technology, Karl-Franzens-University and Joanneum Research.
As a result of increasingly fierce competition, the success of biosimilars and the introduction of new product formats and dosage forms, manufacturers are facing stiffer technological and economic challenges. The complexity of the development process means that this situation can only be improved by an interdisciplinary approach involving the participation of both industry and science.
This sets the scene for the Austrian Center of Biopharmaceutical Technology (ACBT), which was established in September 2001 as part of the Austrian program for industrial competence centres and networks. Biotech specialist Boehringer Ingelheim Austria, Sandoz and Ionimed Analytik joined forces with the Institute of Applied Microbiology of Vienna’s University of Natural Resources and Applied Life Sciences and the Institute for Biochemistry of Innsbruck University. The partners are working together to develop a scientific and technological basis for competitive biopharmaceutical process development. ACBT’s research program centres on process optimisation in the production of recombinant proteins for use as therapeutic agents.
VTU Technology GmbH, a subsidiary of VTU Group, is also involved in protein production, with the emphasis on protein production in yeast for pharmacological applications, biocatalysis, diagnostics, food & feed, etc. A milestone was the development of synthetic promoters to enhance productivity in yeast strains for protein expression.
Target enzymes – quicker, cleaner and in larger quantities
A new system for the production of proteins in yeast cells has been developed at the Institute of Molecular Biotechnology of Graz University of Technology. With the help of gene technology, an optimised expression system has been developed which turns the Pichia pastoris yeast strain into a “super yeast”. The technology is now being brought to market by VTU Technology GmbH.
This technology enables target proteins – pharmaproteins and enzymes for diagnostics, for food, cosmetics, paper and cellulose industries, for fine chemicals, or for enhancing renewable raw materials – to be produced more quickly, more cleanly, with less impact on the environment and in larger quantities. For the first time, enzymes that are difficult to access can be produced using large-scale technology – and in a way that is economically viable and environmentally friendly, at that. Historically, some important enzymes could only be extracted laboriously and in small amounts – typically, from plants. VTU Technology’s new production process will make all that a thing of the past.
A plant peroxidase, which can now be produced easily and with a high degree of purity, provides a fine example of how useful the new expression process is: the enzyme used in diagnostic applications had until now to be extracted with considerable effort from horseradish. Another advantage of expression in Pichia pastoris is that the products can be used in foodstuffs.
Enzymes that are difficult to access can be produced using large-scale technology
From Austria to the world
One of the start-ups that has succeeded in becoming a global company with cGMP facilities based in Austria, Australia and Canada is PAA Laboratories GmbH. “The Cell Culture Company” began as a small, venturecapital-financed cell culture laboratory in Austria’s first technology centre in Linz, Upper Austria. The company specialises in the manufacture and worldwide distribution of cell culture products for research, development, diagnostics and biopharmaceutical production. It processes and manufactures animal & human sera, synthetic media, protein-free media, biochemical supplements and reagents, all of which are used as cell nutrients in cell culture technology.
Further information on Austrian companies on their way to the international market:
LISA is a focal program that acts as a hub for people from all over the world who are interested in the Life Sciences in Austria. Together with its associates in the Austrian regions, ecoplus/Technopole Niederösterreich, OÖ Technologie- und Marketinggesellschaft TMG, including the Upper Austrian Health Technology Cluster, Human Technology Styria, LISA Vienna Region and the Tyrolean Future Foundation, it is the first point of contact in Austria for questions about scientific collaboration, setting up an operation, or funding and sponsoring of projects and businesses in the Life Sciences.