Elution mobile phase and process for immunoaffinity chromatography of viruses

1. A process for virus isolation and purification via immunoaffinity chromatography wherein the process comprises:

(i) binding an antibody to a chromatographic stationary phase; the antibody is specific for a surface protein of the virus which will be subjected to the purifying process; the binding is realized by covalent binding which results in formation of the column for immunoaffinity chromatography;

(ii) then the chromatographic column from the step (i) is:

(a) equilibrated by flushing it with a solution of binding buffer consisting of: 20 mM of 3-(N-morpholino) propanesulfonic acid, 0.15 M sodium chloride at pH=7.2-7.4; followed by

(b) loading of the starting suspension of contaminated viruses which is intended to be purified onto such equilibrated chromatographic column;

(iii) washing of contaminants and non-bonded viruses out of the column by flushing it with the same binding buffer from the step (ii); and

(iv) the elution of the purified virus bounded on the stationary phase of the column is realized by the use of a mobile phase for elution in the immunoaffinity chromatography of viruses that is a solution comprising:

(a) one or more amino acids;

(b) one or more ingredients: L-arginine, glycine, imidazole, or their salts with pharmaceutically acceptable acids;

(c) one or more pharmaceutically acceptable pH adjusting agents, acid or base, for correcting the pH value of the mobile phase to pH=6.0-8.0; and

(d) purified water; up to 100% w/w of the mobile phase composition;

wherein the amino acids (i) are selected from the group consisting of: L-serine <1>, L-asparagine <2>, L-glutamine <3>,

or their salts with pharmaceutically acceptable acids, yielding an eluate in the form of a suspension of purified virus in said mobile phase.

2. A method for purification of viruses by using a mobile phase for elution in immunoaffinity chromatography of viruses that is a solution comprising:

(i) one or more amino acids;

(ii) one or more ingredients: L-arginine, glycine, imidazole, or their salts with pharmaceutically acceptable acids;

(iii) one or more pharmaceutically acceptable pH adjusting agents, acid or base, for correcting the pH value of the mobile phase to pH=6.0-8.0; and

(iv) purified water; up to 100% w/w of the mobile phase composition;

wherein the amino acids (i) are selected from the group consisting of: L-serine <1>, L-asparagine <2>, L-glutamine <3>,

or their salts with pharmaceutically acceptable acids.

3. The method according to claim 2 for purification of infectious from non-infectious viral particles by immunoaffinity chromatography.

4. The method according to claim 2 for purification of viruses selected from the group consisting of:

(a) Avulaviruses;

(b) Morbilliviruses;

(c) Respiroviruses;

(d) Rubulaviruses;

(e) Metapneumoviruses; and

(f) Orthopneumoviruses.

5. The method according to claim 4 , wherein the viruses are selected from the group consisting of: mumps virus, measles virus, and viruses from the family of Paramyxoviridae.

6. The method according to claim 2 , for purification and/or concentration of viral vectors.

7. The method according to claim 2 for purification of viruses selected from the group consisting of:

(a) Newcastle disease virus;

(b) Measles virus;

(c) Human parainfluenza virus 1;

(d) Human parainfluenza virus 3;

(e) Sendai virus;

(f) Human parainfluenza virus 2;

(g) Human parainfluenza virus 4;

(h) Mumps virus;

(i) Parainfluenza virus 5;

(j) Human metapneumovirus; and

(k) Human respiratory syncytial virus.