Characterization of differences in isoelectric focusing behavior of α1-proteinase inhibitor products [6]

Transfusion

Volumn 46, Issue 5, 2006, Pages 872-873

  Marszal, Ewa ^a   Shrake, Andrew ^a  

^a CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

LETTER; PH MEASUREMENT; QUALITY CONTROL; STANDARDIZATION; TEMPERATURE DEPENDENCE; THROMBOCYTE; THROMBOCYTOPHERESIS;

ALPHA 1-ANTITRYPSIN; BLOOD COAGULATION DISORDERS, INHERITED; HUMANS; ISOELECTRIC FOCUSING; ISOELECTRIC POINT;

EID: 33646269250     PISSN: 00411132     EISSN: 15372995     Source Type: Journal    
DOI: 10.1111/j.1537-2995.2006.00809.x     Document Type: Letter

References (7)

1. Re: Biochemical difference in alpha-1 antitrypsin ("AAT") augmentation therapy drug Aralast® from normal pooled human AAT [memo on the Internet] Miami (FL) Alpha-1 Foundation 2005 Jan 11 Available from:
2. American Thoracic Society/European Respiratory Society Statement. Standards for the diagnosis and management of individuals with alpha-1 antitrypsin deficiency Am J Res Crit Care Med 2003 168 818 900
3. 1-antitrypsin variants in plasma with the use of proteomic technology Clin Chem 2001 47 2012 22
4. Chirino AJ Mire-Sluis A Characterizing biological products and assessing comparability following manufacturing changes Nat Biotechnol 2004 22 1383 91
5. Summary basis of approval [monograph on the Internet] Rockville (MD) U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER) 2001 Aug 31 Available from:
6. AlphaNet [homepage on the Internet] Coconut Grove (FL) AlphaNet c2005 Services; [about 1 screen]. Available from:
7. Product approval information - licensing action [monograph on the Internet] Rockville (MD) U.S. Food and Drug Administration. Center for Biologics Evaluation and Research (CBER) 2005 Sep 9 Available from: