Sterilization of self-assembling peptides by irradiation
Assignee3-D Matrix, Ltd.
InventorsMarika G. Rioult, Eun Seok Gil, Elton Aleksi, Naoki Yamamoto
Life of this patent
Estimating the term…
Abstract
Gamma ray and e-beam irradiation provided efficient sterilization of certain self-assembling peptides (including RADA16 in solution) without substantial degradation of the major peptide, while, e.g., another self-assembly peptide, QLEL12 was significantly degraded following irradiation. Irradiation sterilization enhances the rheological property of, for example, RADA16 hydrogel once applied to tissue at a physiological pH. The rheological property increase can result in higher efficacy in a variety of biomedical applications.
Claims12
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 selected from the group consisting of RADA16 (SEQ ID NO:1), KLD12 (SEQ ID NO:2), and IEIK13 (SEQ ID NO:3), and capable of forming a hydrogel when applied to a biological tissue at about neutral pH;
- and
- (b) exposing the container to gamma ray, X-ray, and/or e-beam irradiation at a predetermined dose so that the self-assembling 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 5% w/v while its desired biological or physical properties are maintained substantially at the same level or improved;
- wherein the desired biological or physical properties are selected from the group consisting of:
- hemostatic, anti-adhesion, prevention of re-bleeding, anti-stenosis, tissue occlusion, mucosa elevation, wound healing, storage modulus, viscosity, and tissue void filling property.
Dependencies are inferred from the claim text.