Formulation
Lipid Nanoparticle Services
End-to-end manufacturing bringing your API to the clinic. From formulation development to conducting clinical trials and commercial production, we collaborate closely with clients and partners, working side-by-side throughout the entire drug formulation and development process to bring groundbreaking therapies to fruition.
Lipid Nanoparticle Formulation Optimization
Lipid nanoparticles (LNPs) play a crucial role in the safe and efficient delivery of nucleic acids to cells, protecting delicate RNA molecules within a lipid-based structure. Usually composed of four/five distinct lipids, these particles require precise formulation and manufacturing techniques. Our expertise addresses key technical challenges, including:
- Cationic/Ionizable lipids in-house manufacturing capabilities
- Selecting the appropriate formulation parameters, buffer types and compositions for optimal results, ensuring technology transfer to our in-house GMP manufacturing site
- Developing advanced characterization methods
- Establishing efficient manufacturing processes
- Ensuring long-term stabilization of LNPs
Process development for LNPs
- Mixing Technologies: Microfluidics and T/Y rapid mixing
- Pressure driven pumps: Syringe Pumps, Peristaltic Pumps, Gear Pumps, Piston and diaphragm pumps.
- Tangential Flow Filtration System: (Repligen KrosFlo®KR2i/KMPi and FS500)
- Lyophilization Capabilities (FreeZone® 18L Console and LyoStar® 3.0 ) for R&D and process development.
LNPs Manufacturing Flexibility and Scalability
Our manufacturing capabilities can adapt to changing requirements, whether you require small-scale batches or larger quantities.
cGMP Manufacturing Capabilities
From process development to cGMP clinical production, our state-of-the-art facility offers an extensive range of capabilities:
State-of-the-Art Cleanrooms
- Multiple cGMP Grade C Cleanrooms and One Grade B Aseptic Filling Room
- Minimizes cross-contamination
- Reduces production turnaround times
Wide Range of Validated Vial Configurations
- Available sizes: 2R, 6R, and 10R with various fill volume capabilities
Comprehensive Quality Control
- In-Process Testing
- Reliable Product Release Procedures
Analytical Testing for LNPs
- Particle Size distribution (PDI): Dynamic Light Scattering
- Zeta Potential
- Encapsulation Efficiency
- Nucleic Acid Concentration and Integrity: Fluorescent-based assays (RiboGreen) and Capillary Gel Electrophoresis.
- Lipid Composition (HPLC)
- Osmolality
- pH
- Residual solvent content
- Endotoxin
- Bioburden