Alpha Therapeutic Begins Distribution of Additional Albumin Product Lots From North Filling Suite; Full Portfolio of Plasma Products Now Available to Meet Critical Needs.
Business Editors & Health/Medical Writers
LOS ANGELES--(BW HealthWire)--July 10, 2001
As a result of a recent inspection by the U.S. Food and Drug Administration (FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. ), Alpha Therapeutic Corp. may begin distributing albumin product lots manufactured since February 2001, when the company resumed operations in the North Filling suite of its Los Angeles Los Angeles (lôs ăn`jələs, lŏs, ăn`jəlēz'), city (1990 pop. 3,485,398), seat of Los Angeles co., S Calif.; inc. 1850. plant.
Albumin is a plasma therapy used in emergency settings to treat shock. This means that Alpha is now fully operational and is distributing its entire product portfolio, which also includes coagulation factors for bleeding disorders and immune globulin Immune globulin
Serum containing antibodies against a specific infection.
Mentioned in: Maternal to Fetal Infections for primary immune deficiencies. Additionally, the FDA has lifted some of the redundant testing and third party review it had required prior to releasing individual product lots for distribution. All product lots will continue to be submitted for FDA review and release prior to distribution.
"We are pleased that our ongoing efforts to improve our operations have shown results," said Edward Colton, president & CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "Now that we are back in full production and distribution, we are looking forward to providing a consistent supply of our life-saving products for the people who depend on us."
Alpha collects human blood plasma blood plasma
The yellow or gray-yellow, protein-containing fluid portion of blood in which the blood cells and platelets are normally suspended. from donors across the United States. After screening and testing for blood borne viruses, the plasma is pooled and its protein components are separated into a variety of products. Called fractionation fractionation /frac·tion·a·tion/ (frak?shun-a´shun)
1. in radiology, division of the total dose of radiation into small doses administered at intervals.
2. , this separation process also includes treating the plasma with heat, detergents and filters to inactivate in·ac·ti·vate
1. To render nonfunctional.
2. To make quiescent.
in·acti·va or remove viruses.
In addition to resuming distribution of all its finished plasma products, Alpha also received FDA clearance to distribute "intermediates" or partially processed material which is sold to other fractionation companies for processing.
"Resuming full operations is an important step in the vitality of our company," said Colton. "We have the support of our parent, Welfide Corp., and we are poised for growth. Among other milestones, we are excited about our plans to file an application this year with the FDA for approval of our newest plasma product, alpha-1 antitrypsin, for treatment of hereditary emphysema emphysema (ĕmfĭsē`mə), pathological or physiological enlargement or overdistention of the air sacs of the lungs. A major cause of pulmonary insufficiency in chronic cigarette smokers, emphysema is a progressive disease that commonly ."
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 is available at www.alphather.com.