In-Vivo Base Editing (iVBE) is a genetic medicine technology that allows for precise editing of genes within living cells in the body without cutting both strands of DNA, enabling one-time therapies to correct or switch off disease-causing genes.
iVBE addresses the need for targeted and efficient genetic modifications in living organisms to treat inherited diseases such as cardiovascular and metabolic disorders where traditional CRISPR-Cas9 methods might cause unintended edits due to off-target effects or require multiple treatments.
Lipid nanoparticles encapsulate a base-editor enzyme and guide RNA, which are then delivered directly into the target tissue via an injection. The base-editor converts a single DNA letter (nucleotide) at the precise location specified by the guide RNA, altering the gene's output without making double-strand breaks.
The manufacturing process involves the synthesis of guide RNA, production of lipid nanoparticles encapsulating base-editors and RNA, and formulation into a stable injectable solution. Quality control measures ensure purity and efficacy of the components before clinical use.
Components are synthesized or produced separately, then combined in a cleanroom environment under sterile conditions. The mixture is loaded into delivery devices for testing and eventual clinical trials.
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