Alpha Therapeutic Begins Distribution of Additional Albumin Product Lots From North Filling Suite; Full Portfolio of Plasma Products Now Available to Meet Critical Needs.
LOS ANGELES--(BW HealthWire)--July 10, 2001
As a result of a recent inspection by the U.S. Food and Drug Administration (FDA), 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 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 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. "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 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, this separation process also includes treating the plasma with heat, detergents and filters to inactivate 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."
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.
|Printer friendly Cite/link Email Feedback|
|Date:||Jul 10, 2001|
|Previous Article:||LAWA Receives Seventh Straight Financial Reporting Award.|
|Next Article:||Thor Ventures Corp. Announces Investigation of Oil and Gas Resources Business Opportunities.|