Alpha Therapeutic Prepares to Distribute Plasma Products From South Filling Facility; Company Begins Submission of Product Lots for FDA Review.Business Editors & Health/Medical Writers BIOWIRE2K LOS ANGELES--(BW HealthWire)--Nov. 7, 2000 This week Alpha Therapeutic Corp. will submit product lots to the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for release consideration. These plasma-derived products were filled in the company's South Filling facility in the months since it resumed operations on Feb. 23, 2000. Under routine operations, individual lots of plasma products must be submitted to and released by the FDA before they may be distributed. Products filled in the aseptic aseptic /asep·tic/ (-tik) free from infection or septic material. a·sep·tic adj. Of, relating to, or characterized by asepsis. South Filling facility include clotting factors Clotting factors Substances in the blood that act in sequence to stop bleeding by forming a clot. Mentioned in: Partial Thromboplastin Time clotting factors, n. (Factor VIII factor VIII n. A factor in the clotting of blood, a deficiency of which is associated with hemophilia A. Also called antihemophilic factor, antihemophilic globulin, antihemophilic globulin A, and Factor IX) and immune globulin Immune globulin Serum containing antibodies against a specific infection. Mentioned in: Maternal to Fetal Infections intravenous (IGIV IGIV Immune Globulin Intravenous ). Alpha had been instructed by the FDA to suspend operations at the Los Angeles plant in August 1999, pursuant to a Consent Decree A settlement of a lawsuit or criminal case in which a person or company agrees to take specific actions without admitting fault or guilt for the situation that led to the lawsuit. A consent decree is a settlement that is contained in a court order. . Since resuming operations this year, the company has been distributing products from inventory that were manufactured prior to August 1999 and released by the FDA. Now that certain requirements have been met, the company will begin submitting 2000 inventory from the South Filling facility to the FDA for review and release consideration. "This is a major step forward, not only for Alpha, but also for the patients who depend on these life-saving therapies," said Edward A. Colton, president and chief executive officer. "We have made major improvements to our facilities and everyone at Alpha is fully committed to compliance with Good Manufacturing Practices." For the last several weeks, Alpha has been making additional improvements in the flow of personnel and material in the South Filling facility as part of routine, scheduled construction activity and expects to resume normal filling operations in December 2000. Alpha is a leading developer of plasma-derived biopharmaceutical products including coagulation factors, immune globulin and albumin. With headquarters in Los Angeles, Alpha is committed to providing high-quality, safe and cost-effective therapeutics for improved patient care worldwide. Additional company information and full prescribing information for all products are available at www.alphather.com or by calling 800/421-0008. |
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