LNP Drug Product
Addressing Challenges in LNP Encapsulation
mRNA is a promising therapeutic agent to prevent and treat various diseases. However, the instability of the mRNA structure makes it easy to degrade in vivo. Lipid nanoparticles (LNP) are one of the most commonly used delivery systems that allow mRNA to release safely and effectively in target organs.
With years of dedication to developing LNP delivery systems, Innoforce possesses a series of proprietary technologies and robust manufacturing processes.
Robust and Stable Process for LNP Encapsulation
01 Process development
Innoforce offers access to different LNP technologies. Customized to your projects, our process development team can work efficiently to develop best-matched technologies and processes.
02 GMP manufacturing
Innoforce has a large-scale capacity for LNP encapsulation, currently up to 500L, to support clinical and commercial supply. Incorporating proprietary LNP encapsulation technologies and expertise, Innoforce has successfully delivered 50L GMP lots of LNP drug products and is ready to support your project.
Proprietary Technology and Robust Process Empower your mRNA Programs
Case Study: Encapsulation
At Innoforce, we accept different formulations, or you could choose Innoforce's proprietary formulation to encapsulate your mRNA. Through our testing of different formulations, encapsulation efficiencies as high as 98% are achievable. Innoforce’s mRNA platform is highly stable and robust, with low deviations seen from batch to batch.
Encapsulation Efficiency (Innoforce Formulation)
Case Study: Drug product stability
The complexity of the LNP structure significantly influences the stability of LNP products. Problems in process or formulation can lead to incomplete encapsulation or instability of these LNP products. Innoforce’s proven LNP platform provides high stability of LNP drug products, as demonstrated by testing freeze-thaw stability and storage stability under different temperatures. The results demonstrated good freeze-thaw stability after five cycles and good storage stability at -80℃, -20℃, 2-8℃, and 25℃.
Freeze-thaw Stability
Case Study: High-Concentration-mRNA LNP Encapsulation Technology
When mRNA therapy is utilized for gene therapy or protein replacement, a high concentration of mRNA is required. However, sharp decreases in LNP encapsulation efficiency tend to occur as mRNA concentrations increase. Innoforce has developed a proprietary technology to address this critical issue plaguing the industry, thus allowing excellent LNP encapsulation efficiencies even with high mRNA concentrations.
Encapsulation efficiency remains at over 90% when mRNA concentrations are increased
Case Study: Encapsulation
Case Study: Drug product stability
Case Study: High-Concentration-mRNA LNP Encapsulation Technology
Analytical Capabilities
Innoforce has established robust and reproducible analytical methods based on the current regulatory environment and clients’ needs. We can perform more than 122 analytical assays and provide clients with multiple method options to balance efficiency, compliance, and costs.
Quality Attribute
General PropertiesAppearance (color and clarity)Visual Inspection
pH pH Meter
Fill Volume Gravimetrically Determined
Visible Particles Lamp Inspection
Sub-visible ParticleLight Obscuration
Osmolality   Osmometer
Key Physicochemical PropertiesParticle SizeMarlven
Zeta PotentialMarlven
ContentmRNA ConcentrationHPLC/UV/Ribogreen
Lipid Quantification (4)UHPLC-CAD
Lipid Identity (4)UHPLC-CAD
mRNA IntegrityCE/HPLC
Purity/ImpurityEncapsulation   EfficiencyRibogreen/HPLC
Organic Solvents 

 (Ethyl Alcohol)

SafetySterilityDirect Inoculation 
BioactivityIn Vitro PotencyFACS/ELSA

1500 Fannie Dorsey Road Sykesville, MD 21784 USA +1 (224) 430-0311 cdmo@innoforcepharma.com
No. 376 Fengtu Street, Xiaoshan District, Hangzhou, China +86 571 8281 6679 cdmo@innoforcepharma.com
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