Hassle-free Scale-up｜LNP 開發生態系

Sunny Suite by Unchained Labs represents a complete ecosystem for lipid nanoparticle (LNP) development, offering an integrated workflow from early-stage formulation screening through process optimization to GMP-compliant clinical production. This end-to-end platform addresses the critical challenges in nanomedicine development by providing consistent, scalable microfluidic mixing technology across all stages of development.

The Sunny Suite comprises three core instruments: Sunscreen for high-throughput formulation screening, Sunshine for process development and optimization, and Sunbather for GMP manufacturing. Each system utilizes identical precision pump technology and reusable Sunnies microfluidic mixing chips, ensuring seamless process transfer without the need for re-validation when scaling from discovery to clinical production.

Sunscreen enables automated screening of up to 96 unique LNP formulations in approximately 6 hours, with minimal sample consumption starting from just 105 µL input volume. The platform's automated needle and aspiration technology significantly reduces the consumption of expensive nucleic acid payloads and novel lipids during early development stages. Each experiment requires only 400 µL at a 3:1 flow rate ratio, with automated cleaning between experiments preventing cross-contamination.

Sunshine provides flexible process development capabilities, supporting volumes from 1 mL screening experiments to continuous flow production of tens of liters per day. Available in three configurations—Sunshine, Sunshine Lite, and Sunshine Single—the platform accommodates diverse workflow requirements. The full Sunshine configuration includes automated multi-experiment protocols, continuous flow mode, and integrated in-line dilution for comprehensive process optimization.

Sunbather delivers GMP-ready production with 21 CFR Part 11 compliant software featuring administrator and operator access levels, comprehensive audit trails, and password signoff for process-critical actions. The system provides up to 1.8 L/h throughput with fully replaceable flow paths, traceable wetted materials, extractables data, and complete IQ/OQ documentation for regulatory compliance.

Central to the Sunny Suite's performance are the Sunnies microfluidic mixing chips, precision-engineered glass devices with nanometer-level surface smoothness. Multiple chip geometries are available: Sunny Trident for controlled laminar flow mixing with integrated in-line dilution; Sunny X and Sunny T series offering cross-type and T-mixing configurations in 100 µm, 190 µm, and 275 µm channel sizes for induced chaotic flow; Sunny 150 3D providing three-dimensional flow focusing; and Sunny 50 Micromixer for achieving minimum particle sizes through highly chaotic flow at all flow rates.

The microfluidic mixing principle relies on the rapid change in solvent polarity when lipids in organic solvent meet nucleic acids in aqueous buffer. Faster mixing produces smaller particles, while uniform mixing ensures tight particle size distribution. The Sunnies chips' chemically inert glass construction with ultra-smooth channels enables reproducible particle assembly with typical particle sizes ranging from 40-200 nm, PDI values below 0.2, and encapsulation efficiency exceeding 90%.

Beyond the core synthesis instruments, the Sunny Suite ecosystem integrates with supporting technologies for complete LNP characterization and purification. Stunner AF provides high-throughput, low-sample-volume analysis of particle size, concentration, and encapsulation efficiency through a streamlined 1-step EE% measurement. Big Tuna and Unagi automated buffer exchange systems enable efficient removal of organic solvents and sample concentration with recovery rates of 96% or higher.

The Columbia University case study demonstrates the practical benefits of the Sunny Suite platform. Dr. Santiago Correa's Nanoscale Immunoengineering Lab at Columbia University adopted Sunshine to overcome limitations of manual nanoprecipitation and DIY microfluidic systems. The platform delivered substantially better consistency, reproducibility, and yield in LNP formulation while eliminating tedious hands-on processes, enabling the research team to explore alternative parameters and broaden the scope of their immunomodulatory nanoparticle research.

Key specifications across the Sunny Suite platform include total flow rate ranges from 0.1 to 30 mL/min depending on configuration, flow rate ratios from 1:1 to 10:1 (aqueous to organic), and compatibility with various nanoparticle types including LNPs, polymer nanoparticles, and liposomes. The chemically resistant flow path accommodates diverse solvents and reagent types, supporting the development of novel nanomedicines for mRNA therapeutics, gene therapy, and targeted drug delivery applications.