FDA Approves Baxter Manufacturing Upgrades
The U.S. Food and Drug Administration (FDA) has approved several manufacturing upgrades at Baxter Healthcare Corp.'s Glendale, CA-plant, which performs fractionation, purification and aseptic filling of Baxter's plasma-based pharmaceuticals. The upgrades will fill what some view as a dire industry shortage of these products. According to Baxter several of its plasma-derived products, such as coagulation factors, albumin, and immune globulins, have been in short supply for the past several years due to manufacturing constraints in the plasma fractionation industry.
"Baxter has invested significant time and resources to upgrade our blood therapies operations, thereby allowing us to maintain continued supplies of vital plasma-derived blood therapies for patients," said Michael A. Mussallem, Baxter group vice president.
The approval comes on the heels of two recent milestones in Baxter's blood therapies operations. Last month, the FDA approved Baxter's new biotechnology facility located in Thousand Oaks, CA, which manufactures genetically engineered clotting factor for people with hemophilia, known as Recombinate Antihemophilic Factor (recombinant). Over the past summer FDA granted the company a license to manufacture one of the main ingredients used to produce Gammagard S/D intravenous immune globulin (IVIG), at Baxter's Hyland Immuno plasma fractionation facility in Rochester, MI. IVIG is used to boost patients' weakened immune systems.
Factor VIII
Recombinant Factor VIII, one of Baxter's key blood therapy products, was introduced in 1992. Like other Factor VIII products, Baxter's stops bleeding in hemophiliacs. Unlike other products, which are made from human plasma, Recombinant Factor VIII does not use blood at all, thereby eliminating the potential for spreading blood-borne illnesses.
Figure 1: Genes for Factor VIII introduced into cells
The three basic steps for expressing Factor VIII are:
- Inserting the factor VIII gene into a circular strand of DNA known as a plasmid.
- Inserting the resulting plasmid containing the factor VIII gene into the host cell.
- Recombination, whereby the plasmid moves into the nucleus of the host cell and "recombines" with the host cell's DNA.
Figure 2: Purification of Factor VIII
Factor VIII is then purified using antibody-coated membranes that capture the factor VIII protein (top). Byproducts and cellular debris are washed away (center), followed by a release step, producing pure factor VIII (bottom).
Baxter has been in the blood therapies marketplace for more than 50 years and intends to stay for the long haul. The company is credited with pioneering both the first commercial therapy for hemophilia as well as the first bioengineered Factor VIII. Today, Baxter's blood therapies portfolio includes coagulation factors, immune globulins, albumin and wound sealants.
Figure 3: Purifying Factor VIII at Baxter's Thousand Oaks facility
Baxter Healthcare Corp. is the principal domestic operating subsidiary of Baxter International, Inc. Through its subsidiaries, Baxter International focuses on a wide range of products and services related to blood therapies (biopharmaceuticals and blood collection, separation and storage devices), in addition to cardiovascular medicine, medication delivery, and renal therapy. Baxter generated 1997 sales of $6.1 billion.
For more information: Deborah Spak, Baxter Healthcare Corp., Rte. 120 and Wilson Rd., Round Lake, IL 60073 Tel: 847-948-2349.