DNA production methods

The use of HIC matrix purification and exonuclease treatment effectively addresses the need for high-purity pharmaceutical DNA compositions lacking bacterial origins and markers, ensuring therapeutic efficacy.

WO2026102108A1 Publication Date: 2026-05-15FLAGSHIP PIONEERING INNOVATIONS VII LLC
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Patent Information

Application Number
PCT/US2025/054340
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-11-07
Filing Date
2025-11-06
Publication Date
2026-05-15

AI Technical Summary

Technical Problem

There is a need for novel therapeutic modalities and methods to address unmet medical needs, particularly in the manufacturing of pharmaceutical DNA compositions that lack bacterial origins of replication and selectable markers, while ensuring high purity and efficiency.

Method used

A method involving hydrophobic interaction chromatography (HIC) is used to purify circular, double-stranded DNA (cdsDNA) molecules by contacting a solution containing these molecules with an HIC matrix, followed by collecting purified cdsDNA, which lacks bacterial origins of replication and selectable markers, and optionally subjecting the solution to exonuclease activity to enhance purity.

Benefits of technology

The method achieves high purity and efficiency in producing pharmaceutical DNA compositions with at least 85% cdsDNA, minimizing linear and concatemeric DNA, and eliminating endotoxins and proteins, suitable for therapeutic applications.

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Abstract

The disclosure provides, for example, a method of making a composition comprising purified DNA molecules. In some embodiments, the method comprises contacting a solution comprising a plurality of circular, double-stranded DNA molecules to a hydrophobic interaction chromatography matrix. In some embodiments, the circular, double-stranded DNA molecules lack one or both of a bacterial origin of replication and a selectable marker.
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