Merck

Synthetic Lipids

Cross-section view of liposome used in drug product development and manufacturing

Synthetic Lipids for Pharmaceutical Applications

We are highly specialized in synthesizing top-quality, GMP lipids for pharmaceutical applications and gene therapy, focusing on tailored manufacturing to meet your specific needs. We also offer a standard portfolio with optimized stability, solubility, and handling characteristics. If lipid blends are needed, we can provide lyophilization and spray drying.

Benefits of our lipids include:

  • Support in every phase of development and marketing
  • cGMPs and site standards that follow ICH Q7 concepts
  • Consistent, high product quality from grams to tons
  • Stability studies and analytical method development and validation
  • Regulatory expertise and counsel from a dedicated team
  • An excellent track record of customer and FDA audits

In addition to portfolio lipids, we offer custom manufacturing and complete support pertaining to lipids manufacture through all phases of development, from R&D to commercial. We excel at synthesizing:

  • Ionizable/cationic lipids
  • Lipids conjugates
  • PEGylated lipids
  • Lipids for passive and active targeting, leveraging our patents/licenses and deep knowledge

*These lipids may require a license from our partners
**These products are typically used in COVID-19 mRNA vaccine formulations

Lipids for mRNA delivery and formulation

Lipid-based particles such as lipid nanoparticles (LNP) are commonly used for mRNA delivery and are the most advanced delivery method for mRNA therapeutics and vaccines. Each lipid nanoparticle consists of four different lipids allowing the mRNA to be carried in it and protected from degradation.

Our portfolio includes CDMO services and all the raw materials required for mRNA lipid nanoparticle formulation development.



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