Vaccine compositions that may be administered to a subject via the buccal and/or sublingual mucosa are provided. Methods for administration and preparation of such vaccine compositions are also provided.

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.

Methods of assembling modified adenoviruses, libraries of adenoviral gene modules and compositions thereof are provided herein.

The present invention relates to a method for virus assay. More closely the invention relates a method for total quantification of adenovirus in a sample as well as total and functional (active) adenovirus in a sample. The method for determining adenovirus concentration in a sample comprises subjecting said sample to SPR (surface plasmon resonance) assay with immobilized FX (Factor X) and/or immobilized CAR (coxsackievirus and adenovirus receptor) on a sensor surface, wherein the adenovirus concentration is determined from sample binding to immobilized FX and/or immobilized CAR. CAR can be replaced by an ligand binding to adenovirus fiber, such as an anti-adenovirus fiber antibody. FX can be replaced by a ligand binding to adenovirus hexon, such as an anti-adenovirus hexon antibody. The method can be used for quality control in an adenovirus purification process, for example for gene therapy.

The present invention provides a method of manufacturing vectors containing a heterologous gene-editing protein comprising providing (a) transforming a host system with a nucleic acid cassette containing a promoter operably linked to a gene encoding a gene-editing protein, wherein the host system also contains a heterologous inhibitor for the gene-editing protein, (b) incubating the host system for a time sufficient for vector production and to release the recombinant vector, and (c) recovering the recombinant vector. Also provided herein are cell lines for expressing vectors containing a gene-editing protein with an inhibitor of the gene-editing protein to prevent leaky expression of the gene-editing protein comprising constitutive expression of an inhibitor of a gene-editing protein.

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 production of gene transfer vectors that have been designed as replication deficient constructs can be inefficient, thus limiting their broad use in medicine. The present invention provides a solution to this problem. It describes how the production efficiencies can be enhanced for gene transfer vectors that are produced by the transfer of DNA and RNA into production cells. The present invention lies m the use of cell cycle control in optimizing the production of gene transfer vectors. The subject of this patent is the modification of cell growth and physiology to enhance the efficiency of vector production. An example is given for the effect of certain media components on the cell cycle and production rate of a fully deleted helper virus independent adenoviral vector. Other applications of this technology are listed.

A method of purifying a composition comprising a group B adenovirus, for example comprising a purification step of: subjecting a composition comprising said group B adenovirus to diafiltration employing a diafiltration-buffer with a conductivity of at least 180 mScm.sup.−1, for example a conductivity of 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, or 290 mScm.sup.−1. Also provided is a composition obtained using the purification method disclosed herein.

This disclosure relates generally to process filtration systems, and more particularly to systems utilizing tangential flow filtration.

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.