Concurrent flow mixing methods and apparatuses for the preparation of gene therapy vectors and compositions prepared thereby
AssigneeSelective Genetics, Inc.
InventorsXian Chen, Mark J. D'Andrea
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Abstract
The invention relates generally to methods and apparatuses that are adapted for the preparation of gene therapeutic compositions, as well as the compositions formed thereby. The invention also relates to methods adapted for making mixtures and condensate compositions. In the various embodiments, the present invention provides controlled and uniform mixing of gene therapy vectors and gene therapy vector vehicles for improved reproducibility, scaleability, stability, and pharmaceutical efficacy. Such compositions are suitable for use in mediation of disease.
Claims28
A method for the preparation of a homogenous mixture comprising two or more molecular entities, comprising:
- concurrently and separately introducing at least a first molecular entity-containing solution and a second molecular entity-containing solution, each in a controlled and independent manner, into at least a first flow-through mixer such that the two solutions contact, mix, and form the homogenous mixture, such that said homogenous mixture exits from the flow-through mixer at a controlled rate, and wherein said first and second molecular entity-containing solutions collectively comprise at least one vector and at least one vehicle;
- wherein said vehicle is selected from the group consisting of a ligand, a polycation, and a matrix formulation.
A method of preparing uniform size particles comprising a DNA:condensing agent condensation complex of a predetermined size, comprising the steps of:
- a) providing i) a DNA-containing solution, ii) a condensing agent-containing solution, and iii) a flow-through mixer;
- and
- b) concurrently and separately introducing said DNA-containing solution and said condensing agent-containing solution, each in a controlled and independent manner, into said mixer such that the two solutions contact, mix, and form a mixed solution containing a DNA:condensing agent condensation complex of predetermined size thereby, and such that said condensation complex exits from the flow-through mixer at a controlled rate such that further reaction of said condensation complex with additional DNA- and/or condensing agent-containing solution is avoided.
A method for the preparation of a homogenous mixture comprising two or more molecular entities, comprising:
- concurrently and separately introducing at least a first molecular entity-containing solution and a second molecular entity-containing solution, each in a controlled and independent manner, into at least a first flow-through mixer such that the two solutions contact, mix, and form the homogenous mixture, such that said homogenous mixture exits from the flow-through mixer at a controlled rate;
- and
- isolating a resulting first molecular entity and second molecular entity composition from the resulting homogenous mixture,
- wherein said first and second molecular entity-containing solutions collectively comprise at least one vector and at least one vehicle;
- wherein said vehicle is selected from the group consisting of a ligand, a polycation, and a matrix formulation.
A method for the preparation of a homogenous mixture comprising two or more molecular entities, comprising:
- concurrently and separately introducing at least a first molecular entity-containing solution and a second molecular entity-containing solution, each in a controlled and independent manner, into at least a first flow-through mixer such that the two solutions contact, mix, and form the homogenous mixture, such that said homogenous mixture exits from the flow-through mixer at a controlled rate, and wherein said first and second molecular entity-containing solutions collectively comprise at least one vector and at least one vehicle;
- wherein said vector is a virus and said vehicle is a matrix formulation.
Dependencies are inferred from the claim text.