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BioNanoVesicles (BioNVs) represent a groundbreaking advancement in targeted drug delivery. Derived from allogenic cells, these vesicles are engineered from induced pluripotent stem cells (iPSCs) that possess remarkable properties. By imbuing iPSCs with allogenic, anti-phagocytic, check point inhibition, and anti-cytotoxic properties, we've created a versatile platform for integrating targeting moieties, such as Chimeric Antigen Receptor (CAR) constructs.

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The process begins with the integration of CAR constructs into the iPSC line, which is then differentiated into the desired lineage. This optimized lineage ensures superior BioNV tissue penetration and cellular targeting. Through our proprietary protocols, these cells are activated for drug delivery and processed using a specialized serial extrusion method, enabling the mass production of mini-CAR BioNVs.

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What sets the mini-CAR BioNV apart is its unique composition. With a higher concentration of lipid variants and a significantly increased surface density of critical proteins compared to extracellular vesicles, it offers unparalleled potency in targeting, cellular adhesion, uptake, and endosomal release. This advancement represents a significant leap forward in the field of targeted drug delivery, promising more effective and precise treatments for a wide range of diseases.

BioNanoVesicles: Revolutionizing Targeted Drug Delivery

Immunological
Synapse

Lytic
Granules

Lymphocyte

Cancer Cell

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The mini-CAR BioNV represents a significant advancement in targeted drug delivery, with its key differentiator being the CAR construct. Unlike other targeting approaches, such as antibodies or ligands, the CAR construct offers a dual advantage. First, it leverages the activating features of its intracellular domains to induce the cellular expression of a desired gene, enabling the production of therapeutic proteins or RNA - an achievement unattainable with a simple targeting ligand lacking a signaling domain. Second, the CAR construct's ability to form an immunological synapse (IS) is pivotal. This feature allows us to meticulously select CAR constructs with optimal binding and cellular uptake properties, ensuring precise targeting of the diseased cell while significantly reducing off-target effects. These effects, which may lead to adverse events like cytokine release syndrome (CRS) and inflammation, are mitigated through the CAR construct's specific binding mechanism. Additionally, we use cutting-edge Artificial Intelligence programming that enables rapid assessment of the CAR construct's quality on its intended cellular target within the designated patient population, ensuring the safest and most efficacious outcomes. This comprehensive approach underscores our commitment to advancing the field of targeted drug delivery for the benefit of patients worldwide.

Catalyzing Precision Medicine: The Power of AI Designed CAR Constructs in Mini-CAR BioNVs

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Many delivery technologies face significant challenges in scalability and manufacturing, limiting their potential impact. Issues such as poor yield, lack of homogeneity, high cost, limited drug loading, and batch inconsistency plague many existing methods, including AAVs, Anellovirus, LNPs, and various types of EVs such as exosomes, microsomes, and viral pathway secreted vesicles. Mini-CAR BioNVs, however, represent a paradigm shift in overcoming these hurdles. With a clear pathway to GMP manufacturing for commercialization, mini-CAR BioNVs offer a scalable solution with unmatched efficiency.

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Compared to EVs, mini-CAR BioNVs can be produced in significantly higher quantities, thereby considerably offsetting costs associated with upstream cellular growth and expansion systems. In contrast to AAVs, mini-CAR BioNVs can carry multiple large biomolecule payloads due to their sizeable lumen volume. Furthermore, mini-CAR BioNVs outperform LNPs by avoiding cytotoxic effects and eliminating the need for additional targeting chemistry.

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Mini-CAR BioNVs can be loaded with biologic medicines through expression during the upstream cellular stages of processing or by intrachamber injections during the specialized extrusion process, thereby setting them apart as a highly versatile and efficient delivery system.

Scaling New Heights: Mini-CAR BioNVs Pioneer Next-Gen Drug Delivery Manufacturing

30x to 150x
 

Increase in Product Yield
Compared to EVs

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