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Standards Development
This document provides minimum requirements for the characterization lipid nanoparticle (LNP)- based RNA delivery systems. It provides general attributes as well as key considerations for method selection, measurement process, data analysis, and reporting.
This document is applicable to use of lipid nanoparticle based-mRNA delivery systems for health (vaccine, therapeutics) and non-health sectors, as well as those used as molecular biology such as genome editing.
Part of this series focus on lipid nanoparticle based gene delivery systems. The primary gene of interest is RNA. LNP-mRNA has seen enormous success in recent vaccine development, with the core principle behind mRNA as a technology for vaccination is to deliver the transcript of interest, encoding one or more immunogen(s), into the host cell cytoplasm where expression generates translated protein(s) to be within the membrane, secreted or intracellularly located. LNP based delivery systems are being develop for other therapeutic and nontherapeutic applications, including in genome editing.
Consensus is needed due to the current lack of consistency between terminology and data from different companies and laboratories. Transferring products from a client to a manufacturer while maintaining quality is difficult and often requires a change in methodology. Currently, companies are relying upon comparability studies, which are insufficient. Additionally, due to needed changes in methodology for the assessment and quantification gene delivery systems, historical data is often lost without proper standards.
The current system is inefficient and difficult for research and manufactures. Comparability, consistency terminology, and application of fit for purpose measurements as well as robust reporting schemes would speed up the manufacturing and development process, lower the cost, and support translation of emerging biotechnology products.
Modern and emerging biotechnology is underpinned by the ability to manipulate the genes and genomes of living system. Gene delivery systems are foundational to genome engineering. Gene delivery technology is evolving rapidly with numerous types of gene delivery systems providing a comprehensive set of tools and capability for in vitro or in vivo targeted delivery.
ISO/IS 16921consists of multiple parts to provide common understanding, guides, and analytical method for characterizing these emerging biotechnology tools.
- Part 1: Vocabulary
- Part 2: Viral vectors
- Part 3: Lipid nanoparticles
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