The basis of encapsulation is the design and development of the delivery system. A well-designed delivery system allows mRNA molecules to enter the body without being degraded by RNase, and then be effectively delivered to the target site, cross the cell membrane and be released intracellularly. Lipid nanoparticles (LNPs) are the optimal delivery systems available, with advantages in terms of encapsulation, delivery, and safety compared to other delivery systems. LNPs with nucleic acid fragments are easily swallowed into cells and form intracellular bodies. Once inside the cell, the acidic environment of the intracellular body protonates and positively charges the head of the ionized lipid, which fuses with the inner membrane of the intracellular body and releases the target nucleic acid into the cell for action.
Yaohai Bio-Pharma mRNA service continues to improve, and now can provide mRNA-LNP encapsulation service, optimize relevant critical process parameters, and improve the consistency and reproducibility of mRNA drug production.
Service | Service Details | Delivery Period (Workday) | Deliverables |
mRNA-LNP encapsulation | Preparation of water phase (mRNA) and lipid phase | 2 | mRNA-LNP drug product (DP) |
Microfluidic device mixing | |||
Ultrafiltration concentration | 1 | ||
Sterilizing filtration | |||
mRNA-LNP quality control | Encapsulation efficiency | 1 | Test Report |
Particle size and distribution detection | |||
Surface charge detection | |||
mRNA-LNP expression validation | 5-7 |
Fast synthesis speed, high R&D efficiency and pre-optimized solutions available.
mRNA-LNP encapsulation rate can reach more than 90%.
By changing the fluid injection rate and ratio, the LNP particle size is controlled between 80 and 100nm, and the particle size distribution is uniform (PDI<0.10).
mRNA-LNP is validated by in vitro cell expression and can express the target protein efficiently.
With the help of Yaohai Bio-Pharma's microfluidic encapsulation platform, we optimized the mRNA encapsulation conditions, including the ratio of each component of LNP, the ratio of aqueous phase to organic phase, and the flow rate of each microfluidic phase. The particle size and particle size distribution of the finished mRNA-LNP were then detected.
Experimental results show that through preparation formulation and process optimization, we control the LNP particle size to 80~100nm, and the dispersion coefficient (PDI) is 0.043, indicating that the LNP size distribution is uniform.
Analysis of a mRNA-LNP sample