The FDA's verdict clears the way for the use of the plant to manufacture etanercept, the active ingredient in Enbrel, marketed for the treatment of rheumatoid arthritis by Amgen and Wyeth, as well as other ingredients destined for the US market.
The investment in the plant, put at €255 million, represents one of Boehringer's largest single investments and indeed one of the largest in the European biotechnology industry. Approximately €125 million of the total was financed via a loan with the European Investment Bank.
The new plant has doubled capacity for the production of biopharmaceuticals at the high-tech site - from six 15,000-litre fermenters to 12 - and it has created more than 400 new jobs.
FDA approval comes only about 45 months after the first turf for this complex project was drug. No major shortcomings or criticisms were identified during the in-depth FDA inspection held 17 - 28 May. The inspection investigated not only the plant's ability to meet current Good Manufacturing Practice (cGMP) standards, but also whether data generated in the development and analytical laboratories support the statements made about products in the registration documentation submitted.
Hans-Juergen Leuchs, head of operations and animal health at Boehringer, said that the approval is a major milestone in the utilisation of the new plant for the company's customers, which are primarily located in the USA.
The FDA's approval of the new building consolidates Boehringer's position as a leading player in the contract biomanufacturing sector. Last year, the division's sales increased by 26 per cent to €280 million.
Indeed, biopharmaceutical production is a key element in Boehringer's business, with almost 2,000 employees involved in the development and manufacturing of therapeutic proteins, monoclonal antibodies, single chain antibodies and gene therapeutics, of whom 1,500 are based at Biberach. The company entered this sector in 1986 and has been the market leader in Europe since 1998.
Boehringer claims to be the only corporation worldwide that can cover the entire biotechnological process chain in early development and large-scale commercial manufacturing from genetic engineering, formulation, downstream processing to fill & finish in state-of-the-art application systems, as well as worldwide registration and marketing of biopharmaceuticals.
This is significant, as very few European biotechnology companies have the skills and facilities to take biopharmaceuticals from preclinical development through to market, a point made by Celltech CEO Goran Ando in a preface to a recent Ernst & Young report.