3-D Matrix has been granted a patent for a method of sterilizing self-assembling peptides (SAPs) using gamma ray, X-ray, and/or e-beam irradiation. The method allows for efficient sterilization of certain SAPs without substantial degradation, while maintaining or improving their desired biological or physical properties. This sterilization process can enhance the rheological properties of SAP hydrogels, leading to higher efficacy in biomedical applications. GlobalData’s report on 3-D Matrix gives a 360-degree view of the company including its patenting strategy. Buy the report here.
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According to GlobalData’s company profile on 3-D Matrix, Cyclosporin derivatives was a key innovation area identified from patents. 3-D Matrix's grant share as of September 2023 was 31%. Grant share is based on the ratio of number of grants to total number of patents.
Sterilization of self-assembling peptide solution without degradation
A recently granted patent (Publication Number: US11738114B2) describes a sterilized solution of self-assembling peptide (SAP) and a method for sterilizing it without substantial degradation of the peptide. The method involves placing the SAP solution in containers and subjecting them to gamma ray, X-ray, and/or e-beam irradiation at a predetermined dose. The concentration of degradation products in the solution post-irradiation ranges from 0.1% to 5% w/v, while the desired biological or physical properties of the peptide are maintained or improved. The desired properties include hemostatic, anti-adhesion, prevention of re-bleeding, anti-stenosis, tissue occlusion, mucosa elevation, wound healing, storage modulus, viscosity, and tissue void filling property.
The dose of irradiation is preferably between 15-50 kGy, and X-ray or e-beam irradiation is used. In one specific embodiment, the peptide solution contains 2.5% w/v of RADA16 and is irradiated at a dose of 15-24 kGy. The amount of total peptides degraded after irradiation does not exceed 20% by weight of the initial amount of the self-assembling peptide. The pre-irradiation bioburden of the solution is 9 CFU or less, and the irradiation dose achieves a sterility assurance level (SAL) of at least 10^-6.
The pH of the solution both before and after irradiation ranges from about 1.8 to 3.5. The containers used for the SAP solution are plastic syringes. Post-irradiation, the storage modulus of the gelled solution is increased by at least 10%. The solution can also be subjected to shearing post-irradiation to reduce or restore its storage modulus. Additionally, the SAP solution exhibits a post-irradiation mass spectrometric (MS) profile with major Mz peaks at 836/1670, 1100, and 1513 m/z.
This patent provides a method for sterilizing self-assembling peptide solutions without significant degradation of the peptide. The sterilized solution maintains or improves its desired biological or physical properties, making it suitable for various applications such as hemostasis, wound healing, and tissue occlusion. The use of specific irradiation doses and techniques ensures the achievement of a high sterility assurance level while minimizing degradation. The patent also highlights the importance of controlling the pH of the solution and the potential for post-irradiation manipulation of the storage modulus. Overall, this invention offers a valuable contribution to the field of self-assembling peptide solutions and their sterilization.
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