Formulation

Lipid Nanoparticle Services

End-to-end manufacturing bringing your therapeutics 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.

We are motivated to being the best LNP CDMO for our present and future clients. 

We are able to produce proprietary lipid formulations and support analytical testing. Contact us for more on how we can support your formulation goals.

Lipid Nanoparticle Formulation Optimization

Lipid nanoparticles (LNPs) play a crucial role in the safe and efficient delivery of nucleic acids to cells, protecting RNA molecules within a lipid-based structure. Usually composed of a number of distinct lipids, these particles require precise formulation and manufacturing techniques. Our expertise addresses key technical challenges, including: 

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 and optimized manufacturing processes
  • Ensuring long-term stabilization and storage of LNPs

Process development for LNP formulation

  • 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 LNP-CDMO capabilities can adapt to changing requirements, whether you require small-scale batches or larger quantities. 

cGMP Manufacturing Capabilities

From process development to GMP 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
  • Long term and accelerated stability studies

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
  • Our QC department can support method development for other desired analytical tests.