A process for assaying viral vector manufactured by large-scale viral vector manufacturing processes to assure the resulting vector has acceptable purity and potency. The process entails three different types of assays, each one of which is optionally useful on a stand-alone basis, and which together provide the first system able to assure the quality of viral vector produced by large-scale vector manufacturing processes.

The present application provides a method for producing recombinant adenovirus. The method comprises expansion of the recombinant adenovirus packaging cells from the Working Cell Bank and re-expansion of the cells after inoculation in a packed bed bioreactor in order to obtain a re-expanded recombinant adenovirus. The present application also provides the use of a packed bed bioreactor for recombinant adenovirus production.

The present invention relates to a method for stabilising viruses or bacteria, the method comprising embedding the viruses or bacteria in an aqueous solution, wherein the solution comprises: (i) at least three different amino acids; or (ii) at least one dipeptide or tripeptide and wherein the solution is free or substantially free of sugar(s), silanes and protein(s).

Methods for rapidly confirming production of infectious viral vectors, for use in clinical grade personalized neo-antigen vaccines for subjects in need thereof, are provided.

The present invention relates generally to recombinant adenoviral pharmaceutical formulations. More particularly, the present invention relates to SiO.sub.2-gel-based controlled release recombinant adenoviral pharmaceutical formulations.

Disclosed herein is an optogenetics-based gene therapy that involves channelrhodopsin fusion proteins having an inner mitochondrial membrane-mitochondrial localization signal (IMM-MLS) that can effectively target the fusion protein to an inner mitochondria membrane, and a channelrhodopsin ion channel domain that can change the mitochondrial membrane potential (m) when light is present. The disclosed optogenetics-based gene therapy system can in some embodiments further involve luciferase fusion proteins to stimulate the channelrhodopsin without reliance on external light that has an outer mitochondrial membrane-mitochondrial localization signal (OMM-MLS) that can effectively target the luciferase fusion protein to an outer mitochondrial membrane, and a luciferase protein that can produce a bioluminescence in the presence of a luciferase substrate.

The present invention relates to novel adenovirus strains with a high immunogenicity and very low pre-existing immunity in the general human population. The absence of detectable neutralizing antibodies is due to novel hypervariable regions in the adenoviral capsid protein hexon. The present invention provides nucleotide and amino acid sequences of these novel adenovirus strains, as well as recombinant viruses, virus-like particles and vectors based on these strains. Further provided are pharmaceutical compositions and medical uses in the therapy or prophylaxis of a disease, and methods for producing an adenovirus or virus-like particles utilizing the novel sequences, recombinant viruses, virus-like particles and vectors.

Viruses, and particularly genetically engineered, replication deficient viruses such as adenoviruses, poxviruses, MVA viruses, and baculoviruses which encode one or more antigens of interest, such as TB, malarial, and HIV antigens, are spray dried with a mannitol-cyclodextrin-trehalose-dextran (MCTD) to form a powder where the viability of the viruses are maintained at a suitable level for mass vaccinations after spray drying, and where the viability of the viruses are maintained at suitable level over a period of storage time, even in the presence of humidity.

Immunogenic compositions comprising viral vectors and surfactants are provided. Methods for administration and preparation of such compositions are also provided.

Provided are compounds that enhance the efficacy of viruses by increasing spread of the virus in cells, increasing the titer of virus in cells, or increasing the antigen expression from a virus, gene or trans-gene expression from a virus, or virus protein expression in cells. Other uses, compositions and methods of using same are also provided.