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Last Updated: March 28, 2024

Claims for Patent: 10,124,024


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Summary for Patent: 10,124,024
Title:Ionizing irradiation sterilization of bacterial minicell-based biopharmaceuticals and methods of use
Abstract: Disclosed herein are methods of terminally sterilizing bacterial minicells or compositions comprising bacterial minicells by exposure to ionizing irradiation. Also disclosed are terminally sterilized bacterial minicells, pharmaceutical compositions comprising the bacterial minicells, and methods of use the bacterial minicells and pharmaceutical compositions.
Inventor(s): Giacalone; Matthew J. (San Diego, CA), Ward; Gary H. (San Diego, CA)
Assignee: Vaxiion Therapeutics, LLC (San Diego, CA)
Application Number:15/887,432
Patent Claims:1. A method of producing a terminally sterilized composition of bacterial minicells for pharmaceutical use, comprising exposing a composition comprising a plurality of bacterial minicells to gamma irradiation.

2. The method of claim 1, wherein said gamma irradiation is at a dose of about 5 kGy to about 40 kGy.

3. The method of claim 1, wherein the dose of the gamma irradiation is sufficient to sterilize the composition to a level conforming to USP <71> standards under version USP 38 NF 33.

4. The method of claim 1, wherein the composition is a pharmaceutical composition comprising a pharmaceutically acceptable excipient, a pharmaceutically acceptable diluent, or both.

5. The method of claim 4, wherein said pharmaceutically acceptable excipient is trehalose.

6. The method of claim 4, wherein said pharmaceutically acceptable diluent is sterile water for injection.

7. The method of claim 1, wherein said composition is in the form of a frozen suspension.

8. The method of claim 1, wherein said bacterial minicells display invasin, comprise perfringolysin O (PFO), or both.

9. The method of claim 1, wherein said composition is in the form of a frozen lyophile.

10. The method of claim 1, wherein said gamma irradiation is at a dose of about 25 kGy.

11. The method of claim 4, wherein said pharmaceutically acceptable diluent is sterile water.

12. The method of claim 8, wherein said invasin is an invasin from Yersinia pseudotuberculosis.

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