Lipids for pharmaceutical applications from Merck - Millipore Sigma

Lipids are the most widely used delivery system for mRNA therapeutics. Lipid nanoparticles (LNPs) provide a safe and effective drug delivery system to target COVID-19 and other diseases. Watch Merck’s animated video about lipid nanoparticles and lipids here:

Your global partner for the manufacturing of synthetic lipids

A GMP-scalable process which yields a high-quality lipid is essential to lipidic drug product development and manufacturing. Merck is highly specialized in synthesizing top-quality GMP lipids for pharmaceutical applications and gene therapy, focusing on tailored manufacturing to meet your specific needs. They also offer an off-the-shelf catalog with optimized stability, solubility, and handling characteristics. If lipid blends are needed, they can provide lyophilization and spray drying.

Our sites all over the world, including Western Europe, meet the high regulatory demands for the manufacture of synthetic lipids, using ICH Q7-compliant quality systems. Committed to consistently high product quality, reliability of supply, and short delivery timelines, we assist you through all phases of clinical development and commercialization and help you meet your development milestones.

We manufacture portfolio lipids, PEGylated lipids, cationic/ ionizable lipids, and targeted lipids.

Merck’s Offerings:

Support in every phase of development and marketing
cGMPs and site standards that follow the concepts of ICH Q7
Consistently 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

Merck‘s portfolio of GMP lipids includes:

Neutral lipids	Cationic lipids	PEG lipids	Phospholipids	Others
Synthetic cholesterol** Isomeric mixture 1,3 and 1,2-GDO Tripalmitin	(R,S)-DOTAP Cl or (R)/(S) (R)- DODMA (R)- DOTMA** MoChol*	DSG PEG 2000 DMG PEG 2000	DOPC DPPC DOPE DSPC**	Squalene** Fatty acid: Palmitic acid CHEMS

*Some applications of these lipids may require a license from Merck’s partners.
**These products are typically applied in COVID-19 vaccine formulations

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