Excipients for Stabilising Viral Particles, Polypeptides or Biological Material

1 . A solution, which solution is provided in a sealed container and comprises:

an aqueous solvent;

viral particles or a physiologically active polypeptide;

an excipient selected from a polyethyleneimine; a compound of formula (I) or a physiologically acceptable salt or ester thereof

wherein:

R 1 represents hydrogen or C 1-6 alkyl; and

R 4 represents hydrogen; or

R 1 and R 4 together with the atoms to which they are attached form a pyrrolidine ring;

R 2 represents hydrogen, C 1-6 alkyl or —(CH 2 ) 2-5 NHC(O)(CH 2 ) 5-15 CH 3 ; and

R 3 represents C 1-6 alkyl; or

a compound of formula (II) or a physiologically acceptable salt or ester thereof

wherein:

X represents —S(O) 2 — or —S + (R c )—;

R a and R b independently represent C 1-6 alkyl; and

R c represents C 1-6 alkyl substituted with a carboxylate anion and with an amine (—NH 2 ) moiety; and

optionally, one or more sugars; and

wherein (a) said solution is a sterile pharmaceutically acceptable aqueous solution and said solvent is a pharmaceutically acceptable solvent, or (b) said solution is a ready-to-use, storage-stable aqueous solution.

2 . A solution according to claim 1 which comprises viral particles.

3 . A solution according to claim 2 wherein (a) the viral particles are composed of a live virus or killed virus, or (b) the viral particles are composed of a live virus or killed virus and the live virus is whole virus or live attenuated virus, or (c) the solution comprises a virus selected from Adenoviridae, Orthomyxoviridae, Paramyxoviridae, Parvoviridae, Picornoviridae and Poxviridae, or (d) the solution comprises a virus selected from Adenoviridae, Orthomyxoviridae, Paramyxoviridae, Parvoviridae, Picornoviridae and Poxviridae which is selected from an adenovirus, vaccinia virus, influenza virus or measles virus.

4 . (canceled)

5 . A solution according to claim 1 which comprises a physiologically active polypeptide.

6 . A solution according to claim 5 wherein the polypeptide is:

(a) a hormone, growth factor, peptide or cytokine;

(b) an antibody or antigen- or ligand-binding fragment thereof;

(c) an oxidoreductase, a transferase, a hydrolase, a lyase, an isomerase or a ligase;

(d) a vaccine immunogen;

(e) a tachykinin peptide, a vasoactive intestinal peptide, a pancreatic polypeptide-related peptide, an opioid peptide or a calcintonin peptide;

(f) a monoclonal antibody or fragment thereof;

(g) a chimeric, humanized or human antibody, or fragment thereof;

(h) an oxidoreductase, a transferase, a hydrolase, a lyase, an isomerase or a ligase; or

(i) a full-length viral or bacterial protein, glycoprotein or lipoprotein; or a fragment thereof.

7 . (canceled)

8 . A solution according to claim 1 , wherein the excipient is:

a polyethyleneimine having a number-average molar mass (M n ) between 20 and 1000 kDa or between 1 and 10000 Da;

(b) an N,N-di(C 1-6 alkyl)-, N,N,N-tri(C 1-6 alkyl)-, or N—C 1-6 alkyl-glycine or a physiologically acceptable salt or ester thereof;

(c) N,N-dimethylglycine, N,N,N-trimethylglycine, or N-methylglycine or a physiologically acceptable salt or ester thereof; or

(d) N-methylglycine, N,N-dimethyglycine or N,N,N-trimethylglycine or a hydrochloride salt thereof;

(e) N,N-dimethylglycine or a physiologically acceptable salt or ester thereof;

(f) a compound of formula (IA) or a physiologically acceptable salt or ester thereof

wherein R 5 and R 6 independently represent C 1-4 alkyl and R 7 represents C 1-4 alkyl or —(CH 2 ) 2-5 NHC(O)(CH 2 ) 5-15 CH 3 ;

(g) a compound of formula (IB) or a physiologically acceptable salt or ester thereof:

wherein R 8 and R 9 independently represent C 1-4 alkyl;

(h) a compound of formula (IIA) or a physiologically acceptable salt or ester thereof:

wherein R c and R d independently represent C 1-4 alkyl;

(i) a compound of formula (IIB) or a physiologically acceptable salt or ester thereof:

wherein R e and R f independently represent C 1-4 ; and R g represents C 1-4 alkyl substituted with a carboxylate anion and with an amine moiety; or

(j) dimethylsulfone, N-methyl-glycine, N,N-dimethyl-glycine, N,N,N-trimethylglycine, cocamidopropyl betaine, proline betaine or S-methyl-L-methionine.

9 - 13 . (canceled)

14 . A solution according to claim 1 in which (a) sucrose is present, or (b) sucrose is present and raffinose is also present.

15 . A solution according to claim which is suitable for parenteral administration.

16 . A solution which comprises:

an aqueous solvent;

viral particles;

an N—(C 1-6 alkyl)-, N-N-di(C 1-6 alkyl)- or N,N,N-tri(C 1-6 alkyl)-glycine or a physiologically acceptable salt or ester thereof; and

a sulfone compound of formula (IIC):

wherein R a and R b independently represent C 1-6 alkyl; and

optionally, one or more sugars; and

wherein (a) said solution is a sterile pharmaceutically acceptable aqueous solution and the solvent is a pharmaceutically acceptable aqueous solvent; or (b) said solution is a ready-to-use, storage-stable aqueous solution and is provided in a sealed container.

17 . The solution according to claim 16 (a), wherein (i) the concentration of the N—C 1-6 alkyl-, N,N-di(C 1-6 alkyl)- or N,N,N-tri(C 1-6 alkyl)-glycine or salt or ester thereof is from 0.1 to 1.5M, and/or (ii) the sulfone compound of formula (IIC) is methylsulfonylmethane, and/or (iii) the concentration of the sulfone compound of formula (I) is from 0.1 to 1.5M, and/or (iv) the aqueous solution comprises a non-reducing sugar or sugar alcohol, and/or (v) the aqueous solution comprises sucrose or mannitol, and/or (vi) the sugar concentration of the aqueous solution is from 0.05 to 1M, and/or (vii) the solution is provided in a sealed container.

18 . A solution according to claim 1 , which further comprises:

an adjuvant;

a physiologically acceptable buffer; and/or

a tonicity adjustment agent; and/or

a preservative.

19 . A solution according to claim 1 , which is (a) isotonic, and/or (b) is provided in a sealed container under nitrogen.

20 . A solution according to claim 1 wherein (a) the solution is provided in a sealed vial, ampoule, syringe, cartridge, flexible bag or glass bottle, and/or (b) a unit dosage amount of the viral particles or polypeptide is present.

21 - 39 . (canceled)

40 . The solution according to claim 16 (b), wherein (i) the concentration of the N—C 1-6 alkyl-, N,N-di(C 1-6 alkyl)- or N,N,N-tri(C 1-6 alkyl)-glycine or salt or ester thereof in said solution is from 0.1 to 1.5M, and/or (ii) the concentration of the sulfone compound of formula (IIC) in said solution is from 0.1 to 1.5M, and/or (iii) the said solution comprises a non-reducing sugar or sugar alcohol, and/or (iv) the solution comprises sucrose or mannitol, and/or (v) the sugar concentration in said solution is from 0.05 to 1M.

41 . The solution according to claim 16 (b), wherein (i) the said solution further comprises an adjuvant; a physiologically acceptable buffer; and/or a tonicity adjustment agent; and/or a preservative, and/or (ii) the said solution is isotonic, and/or (iii) said sealed container is a sealed vial, ampoule, syringe, cartridge, flexible bag or glass bottle, and/or (iv) the said solution is provided under nitrogen, and/or (v) a unit dosage amount of the viral particles is present in said solution.

42 - 48 . (canceled)

49 . An aqueous solution which comprises (i) a sample taken from a human or animal, (ii) an excipient as defined in claim 1 , and (iii) optionally one or more sugars.

50 . An aqueous solution according to claim 49 which is sealed in a container and optionally stored in a refrigerator or freezer.

51 - 52 . (canceled)