Process for the inactivation of viruses

• Main Authors: THOMAS NOWAK, GERHARDT KUMPE, ECKHARD SCHULER
• Format: Patent
• Language: English
• Published: 06.05.2004
• Edition: 7
• Subjects: BEER; BIOCHEMISTRY; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, ORSURGICAL ARTICLES; CHEMISTRY; COMPOSITIONS THEREOF; CULTURE MEDIA; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; ENZYMOLOGY; HUMAN NECESSITIES; HYGIENE; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICALARTICLES; MEDICAL OR VETERINARY SCIENCE; METALLURGY; METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS INGENERAL; MICROBIOLOGY; MICROORGANISMS OR ENZYMES; MUTATION OR GENETIC ENGINEERING; ORGANIC CHEMISTRY; PEPTIDES; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES; PROPAGATING, PRESERVING OR MAINTAINING MICROORGANISMS; SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS; SPIRITS; VINEGAR; WINE

A process (I) for the treatment of a plasma protein solution to inactivate and/or eliminate enveloped and/or nonenveloped viruses comprising precipitating viruses with an ammonium salt, is new. A process (I) for treating a plasma protein solution to inactivate and/or eliminate enveloped and/or nonenveloped viruses comprises: (a) incubating the solution with 13-22 wt.% of an ammonium salt at room temperature and alkaline pH; (b) removing the precipitate; (c) removing the ammonium salt to reduce the residual ammonium salt concentration to less than 0.5 mole/liter; (d) pasteurizing the solution at about 60 degrees C for several hours; and (e) processing the solution to obtain a therapeutically usable plasma protein preparation. Independent claims are also included for the following: (1) a process (II) for treating a plasma protein solution to inactivate and/or eliminate enveloped and/or nonenveloped viru comprising: (a) incubating the solution with 13-22 wt.% of an ammonium salt at room temperature and alkaline pH; (b) removing the precipitate; (c) increasing the ammonium salt concentration to 24-27 wt.%; (d) incubating the solution again; (e) collecting the resulting virus-free precipitate; (f) removing the ammonium salt to reduce the residual ammonium salt concentration to less than 0.5 mole/liter; (g) pasteurizing the precipitate at about 60 degrees C for several hours; and (h) processing the precipitate to obtain a therapeutically usable plasma protein preparation; and (2) a plasma protein preparation obtainable by process (I) or (II).