Bayer Manufacturing's multipurpose biotechnology plant in Berkeley, California, US.
The plant is a current good manufacturing practice (cGMP), US Food and Drug Administration (FDA) validated facility.
Kogenate FS produced by Bayer at Berkley is one of the best selling factor VIII products for the treatment of haemophilia.

In August 2000, the Bayer Corporation was granted permission by the city of Berkeley, California, to develop a 14-acre site located south of its 34-acre multipurpose biotechnology plant.

The project was of major significance to the company following the US Food and Drug Administration’s (FDA) decision on 26 June 2000 (and Canadian approval on 24 July) to allow it to sell Kogenate FS in the US.

Shortly after the plant opened in late 2000, the FDA made some preliminary inspections at the site and declared that much of the product had been compromised. Through much of 2001 the needed Kogenate was in extremely short supply to Bayer’s buyer, Aventis. After sorting out the problems in late 2001, Bayer and Aventis signed an agreement in February 2002 for a joint venture (JV) in blood plasma.

“At maximum capacity, the plant is designed to process four separate products simultaneously.”

Kogenate FS is a Factor VIII recombinant protein, which is used to treat haemophilia. Additional manufacturing capacity was required to meet the high demand for the drug.

The approval for Bayer to go ahead and expand the Berkeley Site was, therefore, a major step towards creating this extra capacity. The facility employs more than 1,500 personnel and is Bayer Corporation’s worldwide Biotechnology Headquarters.

Global manufacturing centre of excellence

The Bayer Multipurpose Biotechnology Plant (Building 60) is a pharmaceutical manufacturing facility located near the Berkeley waterfront area. It is the global manufacturing centre of excellence for the company’s Biological Products Business Unit, which produces Kogenate and Kogenate FS for the treatment of haemophilia A, Prolastin for the treatment of alpha 1-antitrypsin deficiency (or Alpha 1), and Thrombate III for the treatment of hereditary antithrombin III deficiency.

The 31-acre Berkeley site also features Bayer’s global biotechnology centre, which is responsible for the discovery, development and process development of recombinant protein drugs and gene-based therapies.

One of the largest buildings of its type on the West Coast of America, Bayer’s Berkeley plant is approximately 110,000ft² in size. Of this, 60,000ft² is dedicated to manufacturing suites and each suite can produce a separate product without interrupting other processes. At maximum capacity, the plant is designed to process four separate products simultaneously.

A current good manufacturing practice (cGMP) FDA validated facility, the plant was one of the first in North America to meet the ISO 14001 standard. This is a comprehensive set of policies that ensure a high level of environmental sensitivity and an ongoing process of continuous improvement. The ISO 14001 certification allows Bayer to compete with other biotechnology companies in Europe, where the ISO standard is required.

Expansion of the Berkeley building

The Berkeley facility comprises a four-level steel-framed structure. There is a utility distribution floor in the basement, offices and conference rooms on the first level and production areas and laboratories on the third and fourth levels. In addition, there are two mechanical levels located immediately above the second and third floors for ease of maintenance and future expansion.

Up to 2005, the Bayer Corporation spent approximately $300m on constructing new facilities at the Berkeley site, including a three-storey, 100,000ft² warehouse/packaging facility, a two-storey, approximately 80,000ft² banking and sterile fill facility, new research facilities in Aquatic Park and a new central services building.

A new USP purified water system providing 35 gallons per minute for the central services building was designed and installed by Stantec. The equipment included pre-filters, water softeners, a chemical injection system for chlorine neutralisation, a preheater and reverse osmosis membranes.

“The site was to be designated as one of Bayer’s three worldwide research and development sites in a global restructuring plan that was completed by mid-2007.”

Former buildings on the site were also upgraded and are used as ancillary buildings. Some portions of the 93-year-old Philadelphia Quartz structures, including 160ft of a brick wall that ran along one side of the property, have been preserved at the request of Berkeley city officials, who wanted to retain some of the traces of the site’s heavy manufacturing history.

In November 2006, Bayer announced new plans to develop the Berkeley site, including the construction of new buildings. The new expansion would require more staff and a broader base of operations. The Berkeley site was to be designated as one of Bayer’s three worldwide research and development sites in a global restructuring plan that was completed by mid-2007.

Sreejit Mohan of Bayer said: “The research areas at Berkeley will focus on protein-related therapies. The plant will also continue to manufacture the bestselling recombinant factor VIII product Kogenate FS.”