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 is the first of its kind in the Central and Eastern Europe.

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 required an investment of Ft25bn ($110m) and the plant became operational in April 2012.

During the initial operating period the plant produced samples for clinical trials and drugs for the commercial market are planned to be manufactured from 2016.

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

The new facility created more than 200 new jobs. The company is investing Ft15bn ($54.5m) in the biopharmaceutical plant to expand the production capacity of biosimilar products. The expansion is expected to create an additional 125 new jobs.

History

In 2007, the company decided 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 a 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 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 enhanced 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.

"The plant has a flexible manufacturing unit that can produce therapeutic proteins."

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 provided financial incentives to the project because of new employment and the value of the project as an addition to the economy.

Construction of the 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 multipurpose biotechnology research and development and manufacturing facility in Debrecen.

The new plant has 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.