Drug – bio-affecting and body treating compositions – Immunoglobulin – antiserum – antibody – or antibody fragment,... – Free from infectious agents
Patent
1996-06-28
1998-06-23
Ivy, C. Warren
Drug, bio-affecting and body treating compositions
Immunoglobulin, antiserum, antibody, or antibody fragment,...
Free from infectious agents
424530, 514 2, 514723, 514772, 530380, 530381, 530382, 530383, 530384, 5303871, 5303901, 530830, A61K 39395, A61K 3516
Patent
active
057701997
DESCRIPTION:
BRIEF SUMMARY
DESCRIPTION
This application is the national phase of PCT/EP94/03298, field Oct. 6, 1994, issued as WO95/09657 on Apr. 13, 1995.
The invention relates to a pharmaceutical preparation comprising a plasma protein which is obtainable by a highly effective method for the inactivation of infectious agents under maintenance of the biological activity.
The invention also encompasses a method for the production of the mentioned pharmaceutical preparation which inactivates detectable, potentially present viruses.
BACKGROUND OF THE INVENTION
Plasma proteins are proteins which can be obtained from human or animal blood and/or plasma. The plasma proteins are intended for pharmaceutical preparations for therapeutic, prophylactic or diagnostic use. Such preparations can contain enzymes, proenzymes including coagulation factors, enzyme cofactors, enzyme inhibitors, immunoglobulins, albumin, plasminogen, fibrinogen, fibronectin, t-PA, urokinase, prourokinase or plasma. Recombinant polypeptides, which are equivalent to the mentioned plasma proteins based on their properties, are also understood as plasma proteins.
Pharmaceutically applicable preparations which are of biological origin, i.e. are obtained from natural sources or cell cultures and/or are produced recombinantly, are understood as biological preparations.
However, immunoglobulin preparations, monoclonal antibodies or fragments thereof, supernatants from cell cultures and ascites fluid from mice are also numbered among biological preparations.
An infection risk from potentially present agents such as hepatitis or AIDS viruses exists with the administration of a biological preparation, especially a plasma protein containing preparation. Therefore, the method of preparation of these preparations must encompass suitable inactivation measures.
Pathogenic agents which can be transferred from one organism to another organism, for example viruses or prions, are understood as infectious agents.
Extensive literature is known which deals with the inactivation of infectious agents in pharmaceutical preparations.
The heating of plasma proteins in solution is one of the most effective methods for inactivation of viruses. It is known that a virus-safe albumin containing preparation can be produced by heating an aqueous albumin solution at a temperature of 60.degree. C. for 10 hours. The biological activity of the albumin is not adversely influenced therewith since albumin is a relatively stable plasma protein.
An increase of the virus inactivation capability of a heat treatment of blood products in solution by the addition of ammonium sulfate is known in the art (EP 124 506). Thereby, the problem of simultaneous inactivation of plasma proteins is known and for this reason it is proposed to add protein stabilizing substances such as glycine. However, a desired stabilization of the plasma proteins simultaneously signifies an undesired stabilization of the infectious agents. Hence, the attempt is to exclude infectiousness of the preparation, and simultaneously, to considerably maintain its biological activity.
Addition of stabilizers to plasma protein containing solutions is known for example from EP 292 003. Saccharides or sugar alcohols and neutral salts such as acetates, phosphates and sulfates are added as stabilizers. Here, salts have a stabilizing effect.
A virus inactivating effect of salts is also described in WO 90/07524. Antibodies against protein C are stable at 22.degree. C. for at least 2 hours in the presence of at least 2.6M guanidine or 2M calcium thiocyanate. Such a treatment is also proposed in order to inactivate potentially present viruses. Due to their chaotropic behavior, the compounds mentioned have an inactivating effect not only with respect to viruses, but also with respect to proteins. Therefore, it is important that the antibodies can be incubated with these compounds for a certain time at room temperature with these compounds without loosing their affinity to protein C.
A method for the inactivation of viruses by addition of sodium thiocyanate to
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Barrett Noel
Dorner Friedrich
Eibl Johann
Huang Evelyn
Immuno Aktiengesellschaft
Ivy C. Warren
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