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Vol. 35, No. 3-4, 1991
Issue release date: 1991
Section title: Original Paper
Horm Res 1991;35:161–166
(DOI:10.1159/000181894)

Combination Ultrafiltration and 6 MUrea Treatment of Human Growth Hormone Effectively Minimizes Risk from Potential Creutzfeldt-Jakob Disease Virus Contamination

Pocchiari M.a · Peano S.b · Conz A.b · Eshkol A.c · Maillard F.d · Brown P.e · Gibbs, Jr. C.J.e · Xi Y.G.f · Tenham-Fisher E.g · Macchi G.g
aDipartimento di Biologia, Università di Lecce, Italia; bIntituto di Ricerche Biomediche ‘Antoine Marxer’, RBM, Ivrea, Torino, Italia; cAres-Serono, Geneva, Switzerland; dLaboratoire Serono, Aubonne, Switzerland; eLaboratory of CNS Studies, NINDS, NIH, Bethesda, Md., USA; fIntituto di Patologia Generale, Università Cattolica, Roma, Italia; gtituto di Neurologia, Università Cattolica, Roma, Italia

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Article / Publication Details

First-Page Preview
Abstract of Original Paper

Received: 9/27/1990
Accepted: 2/26/1991
Published online: 12/2/2008
Issue release date: 1991

Number of Print Pages: 6
Number of Figures: 0
Number of Tables: 0

ISSN: 1663-2818 (Print)
eISSN: 1663-2826 (Online)

For additional information: http://www.karger.com/HRP

Abstract

Although genetically engineered human growth hormone (hGH) is now commercially available, native pituitary-derived hGH is still used by physicians in many countries for the treatment of hormone deficiency states. We describe a method using ultrafiltration and 6 M urea that reduced infectivity in human pituitary tissue that had been deliberately contaminated with scrapie virus (an animal analogue of human Creutzfeldt-Jakob disease virus) from an initial level of 109.7 infectious units to just 5 infectious units. Based on estimates of the frequency of contamination and infectivity levels in batches of human pituitaries, the use of this protocol to prepare GH from cadaveric human glands yields a calculated probability of exposure to a contaminated vial of not greater than 1 in 3.2 million recipients; therefore, native hormone prepared by this method may be considered to be essentially risk-free. The same methodology may be useful in the preparation of other hormones, such as prolactin, for which no synthetic substitutes are currently available, as well as biological products derived from sheep or cattle, that may be infected with scrapie or bovine spongiform encephalopathy.

© 1991 S. Karger AG, Basel


  

Author Contacts

Dr. Maurizio Pocchiari, Istituto di Patologia Generale, Università Cattolica, Lgo. F. Vito, 1, I-00168 Rome (Italy)

  

Article Information

Received: September 27, 1990
Accepted: February 26, 1991
Published online: December 02, 2008
Number of Print Pages : 6

  

Publication Details

Hormone Research (From Developmental Endocrinology to Clinical Research)

Vol. 35, No. 3-4, Year 1991 (Cover Date: 1991)

Journal Editor: Czernichow P. (Paris)
ISSN: 0301–0163 (Print), eISSN: 1423–0046 (Online)

For additional information: http://www.karger.com/HRE


Article / Publication Details

First-Page Preview
Abstract of Original Paper

Received: 9/27/1990
Accepted: 2/26/1991
Published online: 12/2/2008
Issue release date: 1991

Number of Print Pages: 6
Number of Figures: 0
Number of Tables: 0

ISSN: 1663-2818 (Print)
eISSN: 1663-2826 (Online)

For additional information: http://www.karger.com/HRP


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Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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