US 12,083,243 B2
Sterilization of self-assembling peptides by irradiation
Marika G. Rioult, Cambridge, MA (US); Eun Seok Gil, Acton, MA (US); Elton Aleksi, West Roxbury, MA (US); and Naoki Yamamoto, Hokuto (JP)
Assigned to 3-D Matrix, Ltd., Tokyo (JP)
Filed by 3-D Matrix, Ltd., Cambridge, MA (US)
Filed on Jul. 5, 2023, as Appl. No. 18/346,895.
Application 18/346,895 is a continuation of application No. 17/981,445, filed on Nov. 6, 2022, granted, now 11,738,113.
Application 17/981,445 is a continuation of application No. 17/217,911, filed on Mar. 30, 2021, granted, now 11,534,528, issued on Dec. 27, 2022.
Claims priority of provisional application 63/002,882, filed on Mar. 31, 2020.
Prior Publication US 2023/0338613 A1, Oct. 26, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61L 2/08 (2006.01); A61L 2/00 (2006.01); A61L 2/26 (2006.01); A61L 27/22 (2006.01); C07K 7/08 (2006.01); C12N 5/00 (2006.01); A61K 38/00 (2006.01)
CPC A61L 27/227 (2013.01) [A61L 2/0035 (2013.01); A61L 2/081 (2013.01); A61L 2/26 (2013.01); C07K 7/08 (2013.01); C12N 5/0068 (2013.01); A61K 38/00 (2013.01)] 12 Claims
 
1. A method of sterilizing a self-assembling peptide (SAP) solution, the method comprising:
(a) placing one or more containers with the solution of self-assembling peptide into an irradiation machine, said self-assembling peptide capable of forming a hydrogel when applied to a biological tissue at about neutral pH; and
(b) exposing the one or more containers to gamma ray, X-ray and/or e-beam irradiation at a predetermined dose so that the peptide solution is sterilized to a pre-determined Sterility Assurance Level (SAL) without substantial degradation of the peptide, wherein the concentration of the degradation products of a full-length peptide in the solution post-irradiation ranges from 0.1% to 20% by weight relative to the weight of the full-length peptide prior to the irradiation, while its desired physical properties are maintained substantially at the same level or improved;
wherein the full-length peptide is selected from the group consisting of RADA16 (SEQ ID NO:1), KLD12 (SEQ ID NO:2), and IEIK13 (SEQ ID NO:3); and
wherein the desired physical properties are storage modulus and/or viscosity.