Lipid Nanoparticle Delivery System Development

As part of our integrated CDMO offering in Pharmaceutical Development & Manufacturing → Drug Substance Development → Gene Therapy Vector Development, we also focus on non-viral delivery systems that reliably enable nucleic-acid and gene-editing modalities. Our lipid nanoparticle (LNP) platform development services translate bench-scale concepts into phase-appropriate, manufacturable vectors.

Formulation Design Service

We rationally design LNP compositions around ionizable or cationic lipid systems with tailored helper lipid ratios and PEG-lipid selection. Using DoE-guided screening and microfluidic mixing, we establish relationships among N/P ratio, total solids, organic/aqueous phase composition, and critical quality attributes (CQAs) such as particle size distribution, PDI, zeta potential, encapsulation efficiency, and residual solvent levels.

Payload Compatibility & Encapsulation Service

We align nucleic-acid properties with LNP design to maximize integrity and encapsulation. Services include sequence-agnostic payload assessment (mRNA, saRNA, siRNA, plasmid DNA; RNPs where applicable), buffer and counterion optimization, and shear-exposure studies across mixing regimes. We qualify gentle handling steps, define acceptable pH windows for ionizable lipid protonation, and implement nuclease-control strategies.

Process Development & Scale-Down Modeling Service

Focusing on the R&D phase, we establish lab-scale processes that anticipate scale-up. We develop microfluidic or impingement-jet mixing parameters (flow-rate ratios, total flow, channel geometry surrogates), hold-time studies, post-dilution conditioning, solvent exchange, sterile filtration compatibility, and fill–finish-relevant attributes (osmosmolality, viscosity). Scale-down models reflect equipment-independent dimensionless groups to preserve mixing similarity and enable scenario testing before larger-scale engineering runs.

Analytical Method Development & Characterization Service

We build an orthogonal method suite mapped to CQAs: particle sizing by DLS and orthogonal imaging, encapsulation and free-payload assays, lipid ratio verification, residual solvent and reagent profiles, nuclease/pyrogen assessments, pH and osmolality, PEG-shedding kinetics proxies, and stress-response fingerprints.

In-Vitro Potency & Transfection Assay Development Service

We configure well-controlled in-vitro assays to benchmark functional delivery using characterized cell systems and reporter constructs or qPCR-based readouts. Assay system suitability, reference LNP controls, and exposure paradigms are defined to reduce inter-assay variability. Readouts are linked back to physicochemical attributes, supporting formulation ranking, stability decision-making, and dataset packages for internal reviews and partner due diligence.