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Provenance attestation of human cells using physical unclonable functions

使用物理不可克隆功能证明人类细胞的来源

基本信息

批准号：
10603174
负责人：
ALEXANDER PERTSEMLIDIS
金额：
$ 36.16万
依托单位：
SYNTAXISBIO, INC.
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-19 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10603174
关键词：
Accountability Advanced Development Authorization documentation Bar Codes Biological Models CRISPR/Cas technology Cell Culture Techniques Cell Line Cells Clustered Regularly Interspaced Short Palindromic Repeats Custom DNA DNA delivery Data Development Disease model Ecosystem Electroporation Engineering Ensure Foundations Freezing Funding Agency Future Genetic Genetic Services Genome Genomics Government Government Agencies Growth Health Human In Vitro Institution Intellectual Property Investments Journals Karyotype determination procedure Laboratories Lead Legal patent Libraries Lipids Location Measurement Measures Medical Medical Research Methodology Modeling Monoclonal Antibodies Output Ownership Phase Play Population Pre-Clinical Model Process Production Property Protocols documentation Publishing Quality Control Reading Reporting Reproducibility Reproducibility of Results Research Role Science Security Services Short Tandem Repeat Small Business Technology Transfer Research Source Technology Texas Therapeutic Time Transact Universities Vaccine Research Validation Variant Viral base base editor experimental study falls follow-up genetic technology genome editing insight interest machine learning algorithm novel nuclease operation personalized medicine pre-clinical repaired research and development success technology validation trustworthiness virtual

项目摘要

Project Summary The use of clustered regularly interspaced short palindromic repeats (CRISPR) technologies has spurred myriads of applications critically relevant to human health and, pertinent to the topic of this project, an ecosystem of companies, universities, and governmental laboratories that either offer or are in need of custom CRISPR-based cell line engineering has started to emerge. Foreseeably, in the near future, for each cell line model there will exist hundreds of customized versions, each requiring research and development investment on behalf of the producer and constituting a valuable asset on behalf of the user. Considering the significance of the medical and biomedical applications wherein such cell lines are used, as well as the importance of ensuring accuracy and reproducibility of the corresponding results, this ecosystem could benefit from mechanisms which can protect the intellectual property associated with the production of custom engineered cell lines and can ensure their quality. Unfortunately, effective cell line provenance attestation solutions are not currently available in this ecosystem. Besides limiting the ability of cell line producers to capitalize on their investment, lack of such solutions also results in numerous cell line issues including cross- contamination, misidentification, and procurement from dubious or undocumented sources, which in turn undermine robustness, repeatability and, ultimately, overall efficiency of medical research. To fill this void, herein we focus on one of the most fundamental security primitives which can support integrity and accountability of cell line procurement, namely the ability to associate a unique, robust and unclonable identifier with each transacted product. Herein, SyntaxisBio and its research partner The University of Texas at Dallas (UTD) aim to develop and validate a technology that will enable provenance attestation protocols to introduce accountability in cell line distribution networks. The patent-pending technology termed genetic Physical Unclonable Functions (PUFs) was recently developed in UTD (to appear in Science Advances) and is used to introduce a unique, robust and unclonable identifier in cells. We posit that genetic PUFs can enable a provenance attestation protocol which can be used not only for protecting the intellectual property of a cell line producer but also for bolstering the confidence of a customer in the source and, thereby, the quality of a procured cell line. Specifically, the genetic PUF technology enables the producer of a valuable cell line to insert a unique, robust and unclonable signature in each legitimately produced and authenticated copy of a cell line. The producer of the cell line can ensure that anyone who publicly claims ownership or usage of a copy of this cell line has acquired it legitimately. At the same time, the user of the cell line can be assured of its source and quality, as the producer explicitly confirms its origin and assumes responsibility for its production.

项目总结