선바이오(주)

Overview

CloudPEG™ is a dynamic, reversibly assembled polymer network that forms a highly hydrated, nanoscale protective “cloud” around biological interfaces. Unlike conventional covalently anchored PEGylation, CloudPEG operates through transient, non-covalent interactions, enabling the formation of a compliant and adaptive polymer layer that closely conforms to the underlying surface.

When applied to lipid nanoparticles (LNPs), CloudPEG establishes a steric and hydration barrier that mitigates interparticle interactions, thereby reducing aggregation, stabilizing particle size distribution, and preserving structural integrity under physiological conditions. This dynamic shielding is particularly advantageous in complex biological fluids, where protein adsorption and destabilization are common.

In the context of cell-based therapies, including CAR-T, NK, and MSCs, CloudPEG functions as a synthetic analog of the native glycocalyx. By forming a hydrated interfacial layer, it protects cell membranes from mechanical stress, immune recognition, and nonspecific binding events, while modulating cell–cell and cell–protein interactions in a controlled manner.

A defining feature of CloudPEG is its tunability. The architecture can be precisely engineered in terms of polymer chain length, branching, network density, and interfacial binding affinity, allowing control over layer thickness and surface coverage. Critically, the system also exhibits programmable dissociation kinetics. The reversible interactions that govern CloudPEG assembly enable auto-dissociation in vivo, whereby the protective layer gradually disassembles under physiological conditions—such as dilution, competitive binding, or local microenvironmental changes.

This auto-dissociation behavior allows CloudPEG to provide transient protection during critical phases—such as circulation, administration, or initial tissue exposure—followed by the restoration of the native biological surface and function. As a result, CloudPEG enables a balance between protection and functionality that is difficult to achieve with permanent surface modifications.

Overall, CloudPEG represents a tunable, self-regulating interfacial technology that integrates protective shielding with controlled reversibility, making it broadly applicable across nanoparticle delivery systems and advanced cell therapies.

Application I: LNP Stabilization

• Prevents aggregation and fusion
• Maintains structural integrity during storage and transport
• Compatible with lyophilization and RNA delivery systems

Application II: Cell Therapy Enhancement

Ex Vivo Preservation:

• Reduces membrane damage and aggregation
• Suppresses protein and complement adsorption
• Improves cryogenic and hypothermic stability

In Vivo Immune Shielding:

• Temporarily masks immunogenic epitopes
• Reduces complement activation and IBMIR
• Enables recovery of CAR/TCR function after dissociation

Key Advantages

• Tunable polymer cloud thickness and kinetics
• Dual function: stabilization + immune modulation
• Compatible with LNP and cell therapy workflows

Platform Summary

• Prevents aggregation and cell clustering
• Provides transient immune shielding
• Enables liquid and lyophilized stability
• Integrates with existing manufacturing systems

The CloudPEG platform is designed for seamless integration across both lipid nanoparticle (LNP) systems and Cell Therapy applications. It is fully compatible with existing LNP manufacturing and production workflows, requiring no process redesign or specialized equipment. Implementation is straightforward: CloudPEG is introduced by adding a small number of components directly into already formulated LNPs or into cell therapy preparations, enabling rapid adoption without disrupting established manufacturing protocols.

This plug-in capability allows CloudPEG to be deployed at late-stage processing, including post-formulation or pre-administration steps, which is particularly advantageous for scalable manufacturing and clinical translation.

Functionally, CloudPEG provides robust stabilization during storage and handling by forming a transient, hydrated protective layer that minimizes aggregation, surface degradation, and undesired interactions. In Cell Therapy contexts, this same protective effect extends to shielding cell membranes, enhancing viability, and reducing premature immune recognition during processing and administration.

Importantly, the system is engineered with controlled, reversible interactions that enable auto-dissociation in vivo. Following administration, the CloudPEG layer gradually disassembles under physiological conditions, allowing LNPs or therapeutic cells to recover and expose their native surface properties. This ensures that biological function—such as cellular interaction, targeting, or membrane signaling—is preserved at the point of action while still benefiting from upstream protection.

Together, these features position CloudPEG as a practical, scalable, and biologically adaptive platform for enhancing the stability and performance of both nanoparticle-based and cell-based therapeutics.