The Laboratory and Clinical Guide to RNA Therapeutic Analysis and Patient Management: Advanced Analytical Techniques and Nursing Considerations for the Physicochemical, Functional, and Safe Clinical Application of RNA Therapeutics
Abstract
Background: The success of messenger RNA (mRNA) vaccines has established RNA as a foundation therapeutic modality. The field of RNA therapeutics, however, extends far beyond vaccines and includes heterogeneous molecules like small interfering RNAs (siRNAs), antisense oligonucleotides (ASOs), and circular RNAs (circRNAs), each with its respective set of analytical challenges.
Aim: The aim of this review is to outline advances from 2015-2025 to provide an overall view of the laboratory toolkit required to ensure the identity, purity, potency, and safety of the broad diversity of RNA therapeutics. Furthermore, this review briefly outlines the critical role of nursing professionals in the clinical administration and patient monitoring of these sophisticated therapeutics.
Methods: We conducted a systematic review of the literature, spanning analytical techniques for the analysis of the RNA molecule itself—its primary sequence, integrity, and higher-order structure—and its delivery vehicles, with a focus on lipid nanoparticles (LNPs). Key in vitro and in vivo bioassays for determining biological activity were also discussed.
Results: The analysis delineates a sophisticated, multi-dimensional toolkit. Techniques such as mass spectrometry and capillary electrophoresis determine RNA identity and purity, while methods such as SHAPE probing identify important higher-order structures. Lipid nanoparticle characterization relies on dynamic light scattering and cryo-electron microscopy for parameters like size and encapsulation efficiency. Functional potency is finally verified with cell-based assays and animal models.
Conclusion: A robust and in-depth analytical strategy is the foundation for the development of next-generation RNA drugs. This review is a beginning to address challenges in RNA analysis with a view to guaranteeing the safety and efficacy of such novel drugs.
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Authors
Copyright (c) 2024 Laila Hafez Hakami, Ateyah Laheg Nami Alhadri, Abduallaziz Jarallah Obied Alenzi, Salem Osaimer H Almutairi, Albanderi Enad Alotaibi, Maryam Sushil Alneaimy, Bishi Ahmad Mohammad Moukli, Hind Mohammed Ghaythan Alshehri, Ahlam Motashar Alanazi, Ibrahim Ali Mdarbesh, Khalid Eid Alfaris, Dhifallah Azeeb Alzahrani, Faihan Saud Obaid Al-Otaibi
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