Gedeon Richter Biopharmaceutical Plant, Hungary

In July 2008 Gedeon Richter, one of the largest pharmaceutical companies in Hungary, started to build a facility for the development and manufacture of biopharmaceutical products in the city of Debrecen. It will be the first of its kind in the Central and Eastern Europe region.

The new manufacturing facility is part of Gedeon Richter's long-term strategy to develop its business and expand into new European and international markets.

The construction project will require an investment of HUF15bn ($103.7m) and operations are expected to start by 2012.

During the initial operating period the plant will produce samples for clinical trials and drugs for the commercial market are planned to be manufactured from 2014.

The new facility will employ an additional 110 personnel.

History

It was in 2007 that the company made the strategic decision to enter the field of biotechnology and biopharmaceuticals through the establishment of biotechnological R&D and manufacturing facilities. In August 2007 Gedeon Richter and Helm AG of Hamburg formed a joint venture company with 70% and 30% ownership respectively to develop a biotechnology business using their combined expertise and finance.

Part of the joint venture involved taking over Strathmann Biotec GmbH & Co KG for a consideration of €22.9m. The new entity called Richter-Helm Biologics included a state-of-the-art biotechnological plant for the bacterial type of biotechnology, laboratory R&D and pilot plant capacity.

This entity has 81 employees in three German sites and has given a boost to Gedeon's new business. Gedeon had already established a small-scale laboratory in November 2005 in Hungary, which could be used for the large-scale fermentation of recombinant proteins for human use.

New Debrecen facility

The area to construct the new biotechnology facility was affected by a number of factors including transport access to a motorway, the provision of industrial-scale services and surrounding infrastructure capacity. The Gedeon Richter management decided to build its biotechnological facility in the Debrecen industrial park.

Gedeon Richter applied for a preliminary environmental permit in February 2008 and consequently received the resolution of the regional Inspectorate for Environmental Protection asking for a detailed environment impact assessment and documentation relating to an integrated permit for the use of the environment.

These documents were submitted in May 2008. Following this a public hearing was held on 25 July 2008 to answer any questions.

Gedeon also submitted its application for a business licence to the Hungarian National Institute of Pharmacy (OGYI) in May 2008.

The Hungarian Government is providing financial incentives to the project because of new employment and the value of the project as an addition to the Hungarian economy.

Construction of Hungarian plant

In September 2008 Jacobs Engineering Group of Pasadena announced that it received a contract from Gedeon Richter to provide engineering, procurement and construction management services and validation assistance for the new multi-purpose biotechnology research and development and manufacturing facility in Debrecen, Hungary.

Jacobs will oversee the project from the office in Milan, Italy. The new plant will have a flexible manufacturing unit that can produce therapeutic proteins using insect and mammalian cells and recombinant technology. It can also be used for other technologies with minimal modification.