Innovation, research and development are key elements of Richter’s strategy. In line with this strategy, the product portfolio continues to be expanded with both original and licence products representing high intellectual added value. Unfavourable trends in global pharmaceutical markets, shrinking opportunities in traditional innovation, increasing generic competition and the curbing of subsidy budgets all underline the importance of new fields, such as biotechnology, which offer business potentials for any company thinking in the long-term. The turnover of biotechnological products amounted to USD 60 billion in the United States in 2006 – a 17% increase over the previous year.
It was in 2007 that Gedeon Richter Plc. made the strategic decision to enter the field of biotechnology through the establishment of biotechnological R&D and manufacturing facilities.
The new biotechnological unit in Debrecen offers a good example of the strategic goals of Richter, a company based in Hungary and operated by a Hungarian management. The company intends to establish a complex and competitive biopharma line which will help expand its domestic and international product portfolio with products offering high added value. Moreover, the project will assist in the introduction of biotechnology as a sector representing high intellectual added value to Hungary and thus increase the country’s competitiveness. The project will also create 110 new jobs.
Richter welcomes the Hungarian government’s decision to offer direct subsidies to the project – with view to the investment expenditure and the fact that it is of vital importance for the Hungarian economy as a whole as well as the creation of new workplaces.
Richter has been employing biotechnological processes for more than four decades, mainly in the production of steroid intermediates and APIs with sterile fermentation. The company boasts solid traditions and expertise in both development and manufacture. Thanks to its R&D results and expenditure, Richter remains one of the most significant research bases in Central and Eastern Europe.
Richter has executed major investments in the field of biotechnology in the past few years. In November 2005 the Company announced the completion of a laboratory – unique in Hungary at the time – suitable for the large-scale fermentation of recombinant proteins for human use.
In August 2007 Gedeon Richter and Hamburg-based Helm AG established a joint venture company with 70% and 30% ownership respectively. The acquisition of 22.9 million euros comprises a state-of the-art plant specialising in the bacterial line of biotechnology and the production of recombinant proteins as well as R & D laboratory and pilot plant capacity.
Richter intends to commence the construction of its new biotechnological plant exceeding HUF 15 billion in value in Debrecen’s industrial park in 2008.
Richter’s new plant unique in the region
While the flexible biotechnological manufacturing unit currently under construction in Debrecen’s industrial park can produce therapeutic proteins using insect and mammalian cells, it is also suitable for other technologies with minimal modification.
The plant complies with the latest international quality, safety and environmental requirements for pharmaceutical manufacturing. Owing to the high intellectual and technological added value, the plant’s future products represent significant financial value as well. These kind of technologies can be characterised by low material flow during the production, so the environmental impact is minimal.
The biotechnological plant will commence operations in 2012. In its first years it will produce samples for clinical trials while drugs for the pharmaceutical market are planned to be manufactured from 2014.
On the choice of location
When choosing a location for the biotechnological unit an essential factor was the appropriate environment, namely that the facility should be built in an industrial and not a residential area. Easy access via motorway was also a major consideration. Adequate infrastructure that is, the availability of basic services with appropriate capacities was also a decisive aspect. After careful consideration of the above factors, the Richter management decided to build its biotechnological facility in Debrecen’s industrial park.
Permits in-progress
Having applied for a preliminary environmental permit in accordance with effective regulations, on the 6th of February 2008 Gedeon Richter received the resolution of the regional Inspectorate for Environmental Protection obliging the Company to submit a detailed environment impact assessment and documentation relating to an integrated permit for the use of the environment. The necessary documents were presented 21 May 2008. As the next step of the process, the authorities called for a public hearing to be held 25 July, where potentials questions may be cleared.
In parallel to the above, the Company also submitted its application for a business license to the relevant authority, the Hungarian National Institute of Pharmacy (OGYI) on the 7th of May.
General information on modern biotechnology, with special emphasis on biopharmaceuticals
The Biotechnology Industry Organisation provides the following definition: biotechnology is
„the use of the cellular and biomolecular processes to solve problems or make products”.
Branches of biotechnology
· White (industrial) biotechnology: biotechnological methods applied for instance in the plastics or textile industry to produce environmentally friendly and more effective or cheaper products (e.g. biofuel, washing powder, chemicals etc.)
· Green (agricultural) biotechnology: biotechnological methods used to engineer new cultivated plants with more favourable characteristics (better insect and temperature resistance, drought tolerance)
· Red (human and veterinary medical) biotechnology: production of proteins and other biomolecules to be used in the treatment of human and animal diseases (e.g. insulin, cancer antibodies, proteins for the treatment of chronic rheumatoid arthritis)
(This is the field in which Gedeon Richter intends to introduce new applications.)
Characteristics of biopharmaceuticals
Potential biopharmaceutical preparations may involve the following molecules:
· peptides (e.g. hormones controlling bone degeneration)
· proteins (e.g. insulin, antibodies)
· nucleic acids (DNA, RNA)
· cell and virus particles (e.g. vaccines)
Biopharmaceuticals are almost without exception large molecules, their size ten or hundred times that of traditional small molecules. Their structural complexity increases with size. Biopharmaceuticals are typically not orally administered but the drugs are usually injected directly into the blood system or tissues .
A common characteristic of biopharmaceuticals is that they are very specific that is, they can only interact with the targets they were made for. Therefore, small doses are generally sufficient. Together with the target-specificity, this means that biopharmaceuticals normally have less adverse effects than traditional small-molecule drugs.
The manufacturing of biopharmaceuticals
Biopharmaceuticals can be manufactured with the help of host organisms. These are single-cell organisms which can be easily cultured and which produce the target molecules efficiently, with biological activity and appropriate purity.
Most often used host organisms include the Escherichia coli bacterium for simpler proteins (e.g. insulin) and mammalian cells such as the so-called CHO cell line for more complex proteins (e.g. anticancer antibodies).
Technologies to produce biopharmaceuticals are usually executed in closed reactors under controlled conditions, similar to the technologies associated with traditional pharmaceutical manufacturing.