Baxter to expand recombinant protein manufacturing facility
Baxter Healthcare Corporation recently announced that it is moving forward with an investment to build a fourth manufacturing suite (Suite D) at its Thousand Oaks, California BioScience facility. The facility is the site of manufacture for Baxter's recombinant Factor VIII therapy, Recombinate Antihemophilic Factor (rAHF). Factor VIII is the protein in human blood that is critical for proper blood coagulation and is deficient in people with hemophilia A.
"We are pleased to be able to further expand our manufacturing capacity for recombinant Factor VIII," said Thomas Glanzmann, senior vice president and president of Baxter's BioScience business. "When approved, this additional suite will enable us to better meet the needs of patients who rely on this very important therapy."
Since the construction of the first manufacturing suite at the facility in 1994, Baxter has committed to increasing capacity at this facility. This commitment is based on the continuing growth in demand for recombinant Factor VIII, which is driven by numerous factors, including increased use to prevent bleeding rather than treating patients when bleeds occur. The fourth suite represents an additional investment in the facility of over $50 million and will increase manufacturing capacity at the Thousand Oaks facility by approximately 30 percent. Baxter expects to begin construction later this year and is targeting late 2004 for regulatory approval of Suite D.
The company first received regulatory approval for Suite A in 1998. Last year, Suite B received United States regulatory approval and Suites B and C received European regulatory approval. The company is targeting United States regulatory approval of Suite C later this year.
In addition to the Thousand Oaks facility, Baxter also has a multi-purpose recombinant protein production facility located in Neuchatel, Switzerland. The Neuchatel facility features two state-of-the-art production suites, and currently manufactures product used in the continuing clinical trials of Baxter's next-generation recombinant Factor VIII therapy. Earlier this year, the company announced plans to build two additional production suites at Neuchatel, targeting an annual capacity in excess of one billion units of Factor VIII from this facility.
Hemophilia A is a rare, hereditary, gender-linked disorder caused by the absence or severe deficiency of Factor VIII. Currently there are more than 300,000 persons with hemophilia worldwide.
People with hemophilia A infuse themselves with therapeutic clotting factor, on average, three times per month, unless they are on a preventive regimen, in which case they could infuse multiple times per week. Barring other complications or disorders, clinicians expect a near normal life expectancy for hemophilic infants born today, when patients receive proper treatment.
Baxter Healthcare Corporation is the principal U.S. operating subsidiary of Baxter International Inc. Baxter is a global medical products and services company that, through its subsidiaries, provides critical therapies for people with life-threatening conditions. Baxter's products and services in bioscience (biopharmaceuticals, vaccines, biosurgery and transfusion therapies), medication delivery and renal therapy are used by health-care providers and their patients in more than 100 countries.
Source: Baxter Healthcare Corporation
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