	US 11,849,721 B2
	Methods of preparing pH-stabilized and heat-sterilized organ preservation and/or perfusion solutions
Anne-Li Sigvardsson, Gothenburg (SE); and Elin Sjöqvist, Gothenburg (SE)
Assigned to XVIVO PERFUSION AB, Gothenburg (SE)
Filed by XVIVO Perfusion AB, Gothenburg (SE)
Filed on Mar. 18, 2022, as Appl. No. 17/655,485.
Application 16/181,659 is a division of application No. 15/654,763, filed on Jul. 20, 2017, abandoned.
Application 17/655,485 is a continuation of application No. 16/181,659, filed on Nov. 6, 2018, abandoned.
Application 15/654,763 is a continuation of application No. PCT/EP2017/050881, filed on Jan. 17, 2017.
Prior Publication US 2022/0202006 A1, Jun. 30, 2022
Int. Cl. A01N 1/02 (2006.01); A61K 31/721 (2006.01); A61K 31/70 (2006.01); A61M 39/08 (2006.01)

CPC A01N 1/0226 (2013.01) [A01N 1/021 (2013.01); A01N 1/0221 (2013.01); A01N 1/0247 (2013.01); A61K 31/70 (2013.01); A61K 31/721 (2013.01); A61M 39/08 (2013.01); A61M 2210/12 (2013.01)]

15 Claims

1. A method of preparing an organ preservation and/or perfusion solution for an isolated tissue or organ in a sterile container, the organ preservation and/or perfusion solution having a pH of 6.6 to 7.8 at 25° C. following heat sterilization, the method comprising steps of:

(1) preparing an initial solution comprising dextran, glucose at 0.5 to 5 g/L, calcium ions at 0.3 to 1.5 mM, and tris(hydroxymethyl)aminomethane (TRIS) buffer at 1 to 15 mM in water;

(2) if the pH of the initial solution at 25° C. is not 7.0 to 7.8, then adjusting the pH of the initial solution to 7.0 to 7.8 at 25° C.; and

(3) subjecting the initial solution having a pH of 7.0 to 7.8 at 25° C. to heat sterilization at 115 to 130° C. for at least 5 minutes to achieve an F0 of at least 10, wherein the initial solution is in a container during the heat sterilization, thereby obtaining the organ preservation and/or perfusion solution in the sterile container.