Stabilization of herpes virus preparations

Details Stabilization of herpes virus preparations Stabilization of herpes virus preparations

1999-04-26

2001-07-10

Salimi, Ali R. (Department: 1648)

Drug, bio-affecting and body treating compositions

Antigen, epitope, or other immunospecific immunoeffector

Virus or component thereof

C424S230100, C424S280100, C435S005000, C435S014000, C435S040500

Reexamination Certificate

active

06258362

ABSTRACT:

FIELD OF THE INVENTION
This invention relates to preparations of viruses, e.g. for vaccine or other pharmaceutical or research use, to their stabilisation, and to processes of producing such preparations, as well as to their use, e.g. as vaccines or as virus vectors.
BACKGROUND OF THE INVENTION AND PRIOR ART
It is known to freeze and/or lyophilise viable virus preparations for laboratory or vaccine use in order to preserve their activity.
Numerous methods are known for producing live virus preparations, e.g. herpesvirus preparations, for vaccine and other purposes.
U.S. Pat. No. 5,024,836 (Jun. 18, 1991) (Merck & Co Inc: W J McAleer et al) describes a stable lyophilized live herpes virus vaccine that comprises from about 0.5% to about 8% moisture, and claims a gas injected lyophilized live attenuated varicella virus vaccine which comprises 2% to 8% moisture.
U.S. Pat. No. 5,075,110 (Dec. 24, 1991) and EP 0353108 (Institut Merieux: A J Francon et al) describe stabilization of attenuated lyophilized vaccines with amide or thioamide lyophilization excipients, e.g. urea.
EP 0048194 (Merck & Co Inc.: M R Hillemanet al) describes lyophilization processes in which lyophilization time and expense are reduced by shell freezing liquid vaccine prior to lyophilization by rotating the vial on its side in a liquid bath maintained at a temperature below the eutectic point of the vaccine.
U.S. Pat. No. 4,338,335 (Jul. 06, 1982) and EP 0028563 (Merck & Co Inc: W J McAleer et al) describe stabilizer for liquid vaccines, and stabilized liquid live viral vaccine containing live virus, partially hydrolyzed gelatin, a monosaccharide or disaccharide, a cell culture medium, L-glutamic acid, L-arginine and buffer to maintain pH at from about 6.0 to about 6.5.
EP 0008255 (Merck & Co. Inc.: W J McAleer et al) describes herpes virus vaccine and its preparation, especially Marek's Disease vaccine. The virus is lyophilized in the presence of a pH controlled buffered stabilizer, so that the vaccine can be reconstituted with distilled water.
EP 0295043 (Dec. 14, 1988) (Kitasato Institute: S Makino et al) describes stabilized live attenuated vaccine comprising at least one live attenuated plain virus selected from measles, mumps or rubella virus and, as a stabilizing agent, lactose, saccharose, D-sorbitol, sodium glutamate and gelatin hydrolysate.
EP 0252059 (Smithkline Biologicals S.A.: E D'Hondt) describes stabilizers for attenuated vaccines, containing lactose, sorbitol, dextran, casein hydrolysate, L-glutamate, EDTA and buffer at a pH 6.7-7.2.
WO 96/29096 (Hisamitsu Pharmaceutical Co., Inc.: H Kuma et al) describes production of gene transfer preparations by freeze-drying a mixture of a recombinant virus vector with at least one additive selected among arginine, glutamic acid (or sodium salt thereof), serine, glucose, inositol, lactose, mannitol, sorbitol, trehalose and xylose.
U.S. Pat. No. 4,985,244 (Jan. 15, 1991) (Kitasato Institute: S Makino et al) describes stabilized live attenuated vaccine with improved thermal stability, which comprises live attenuated plain measles, mumps or rubella virus vaccine grown in a medium-199 for cell culture, or a combined live attenuated vaccine, stabilized with lactose, saccharose, D-sorbitol, sodium glutamate and gelatin hydrolyzate.
U.S. Pat. No. 4,622,222 (Nov. 11, 1986) (Phylaxia Oltoanyagtermelo Vallalat: E Horvth et al) describes lyophilized vaccine against duck virus hepatitis using attenuated virus, and its production using infected duck embryos, including lyophilising the sterile virus material with collidone, gelatin, glucose and sucrose.
U.S. Pat. No. 4,500,512 (Feb. 19, 1985) (Institut Pasteur:, M Barme) describes stabilized vaccines containing live viruses, especially for yellow fever virus, and stabilizers comprising phosphate buffer, calcium and magnesium ions, lactose, sorbitol and amino acid selected from histidine, alanine, valine, threonine, arginine, methionine, hydroxyproline, lysine, isoleucine, phenylalanine, serine, preferably histidine and alanine. The stabilized vaccine is lyophilized.
U.S. Pat. No. 3,985,615 (Osaka Res Foundation: T Kubo et al) describes production of live attenuated varicella virus for vaccine use by culture comprising passage in guinea pig primary embryonic tissue cells. U.S. Pat. No. 5,024,836 (Merck: W J McAleer et al) relates to production of lyophilized vaccine preparations based thereon.
U.S. Pat. No. 5,792,643 (Mar. 28, 1997) and WO 95/10601 (Viagene: S M Hermann et al) disclose preservation of infectious recombinant viruses using a saccharide, high molecular weight structural additive, a buffer and water, and cooling the mixture to below the eutectic or glass transition point, and removing water by sublimation to less than 10% water content.
WO 93/18790 (L K Csatary) describes lyophilised viral vaccines (e.g. MDV vaccines) with modified starch such as hydroxyethyl starch mw 100,000-300,000 added as protective colloid prior to lyophilisation.
JP06234659 (Aug. 23, 1994) (Z H Handai Biseibutsubyo Kenkyukai) discloses stabilised live vaccine containing attenuated or recombinant live varicella virus and a stabiliser free from Ca2+ion and Mg2+ion, preferably with gelatin or gelatin hydrolysate or a chelating agent such as EDTA.
EP 0290197 (Nov. 09, 1988) (Merck & Co Inc: R Z Maigetter wet al) discloses stable gas injected lyophilised live herpes virus vaccine comprising 0.5-8% moisture permitting storage at standard refrigerator conditions, i.e. 5 deg. C., rather than freezer conditions (−20 deg. C.). Gas injection during the primary cycle of the lyophilisation process and drying to higher moisture levels reduces the lyophilisation time, typically to 7-11 hrs for combined primary and secondary cycles.
DD-209738 (Cent Cerc Bioprep: I V Patrascu) illustrates production of of herpesvirus vaccine against Marek's disease by (a) culturing embryo cells on dextran microspheres; (b) inoculating the culture at 80% confluence with turkey herpes virus strain FC-126; (c) collecting the infected cells in SPGA medium (sucrose, phosphate, glutamate, bovine albumin fraction V) when the cytopathic effect is 80%; (d) ultrasonic pulsing and centrifugation to recover a first crop of vaccine; (e) resuspending the sediment in SPGA medium and repeating step (d) to obtain a second crop of vaccine (to increase vaccine yield); (f) freezing the combined vaccines at −100 deg. C. prior to determining the virus titre; and (g) diluting with SPGA medium and freeze drying.
JP06234659-A (Z H Handai Biseibutsubyo Kenkyukai) describes, in an example, production of herpesviral vaccine on human diploid fibroblast MRC-5 cells cultured in MEM medium at 37 deg. C.; comprising inoculation of varicella virus Oka strain seed virus at a MOI of 0.03 to MRC-5 cells and culture at 37 deg. C. for 2 days. Virus is then suspended in a solution containing NaCl, KCl, Na2HPO4, KH2PO4, sucrose, L-glutamate, gelatin, gelatin hydrolysate and EDA-3Na.
EP 0 573 107, U.S. Pat. No. 5,360,736 and U.S. Pat. No. 5,607,852 (Merck: P A Friedman et al) describe processes for production of attenuated varicella zoster virus vaccine.
WO 98/28000 (Merck & Co., Inc., Rahway, N.J., U.S.: D B Volkin et al.) describes vaccine formulations (e.g. measles, mumps, rubella, VZV or herpes simplex) comprising 6-carbon polyhydric alcohol, disaccharide and buffer.
U.S. Pat. No. 3,915,794 (Recherche et Industrie Therapeutique, Belgium: Z Nathan and J Petermans) describes stable virus preparations comprising group B herpes virus (e.g. turkey hepersvirus) and a buffered aqueous solution pH 6.5-7.5 comprising polyvinylpyrrolidone, sugar, glutamate and chelating agent.
U.S. Pat. No. 4,147,772 (Apr. 03, 1979) (Merck & Co. Inc: W J McAleer et al) describes a lyophilised vaccine with pH between about 6.0 and 6.5 and comprising live virus, partially hydrolysed gelatin (M.Wt. about 3,000), a 6-carbon polyhydric alcohol, cell culture medium and acidic buffer.
U.S. Pat. No. 5,665,362 and WO 92/05263 (Cantab Pharmaceuticals Research Ltd: S C Inglis et al) and U.S. Pat. No. 5,837,

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