Lipids for pharmaceutical applications
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. 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 an off-the-shelf catalog with optimized stability, solubility, and handling characteristics. If lipid blends are needed, we can provide lyophilization and spray drying. For formulation support, contact us .
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.
Lipids are the most commonly used delivery method for RNA therapeutics and vaccines, and lipid nanoparticles could prove a game changer for COVID-19 and many other diseases. Learn more here.
We are highly specialized in manufacturing synthetic lipids and mRNA for pharmaceutical applications. Our portfolio includes CDMO services and all the raw materials required for mRNA lipid nanoparticle formulation development. Find out more.
More information on our overall relevant product and service offering for COVID-19 can be found here.
- 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
- Regulatory expertise and counsel from a dedicated team
- An excellent track record of customer and FDA audits
As a highly specialized manufacturer of novel excipients, we focus on the tailored manufacturing of synthetic lipids for our customers.
Our portfolio lipids include synthetic lipids with higher stability, solubility, and improved handling characteristics. All of our lipids are being used in various clinical trials, and some also in marketed drug products!
Request Information on Specialty Lipids
Our portfolio of GMP lipids includes:
- Synthetic cholesterol**
- Isomeric Mix 1,2/1,3-GDO
- (R,S)-DOTAP Cl
- (R)-DOTAP Cl*
- (S)-DOTAP Cl*
- (R)-DOTMA Cl
- ALC-0315*, **
- mPEG 2k DSG
- mPEG 2k DMG**
- ALC-0159*, **
- Palmitic acid
*These lipids may require a license from our partners.
**These products are typically used in COVID-19 mRNA vaccine formulations
Besides off-the-shelf lipids, we also offer custom manufacturing and complete support pertaining lipids manufacture through all phases of development, from R&D to commercial. We especially excel at synthesizing:
- Ionizable/ Cationic lipids
- Lipids conjugates
- PEGylated lipids
- Targeted lipids
Lipids for passive and active targeting
Surface modification on liposomes is a very effective method to control their physical and biological behaviors. Specific receptor antigens such as antibodies, peptides or sugar moieties can make liposomes preferentially target certain tissues or cell types. Such immunoliposomes are used in both, therapeutic and diagnostic applications. The targeted lipids could also be modified with antigens for immunological applications.
We have patents/ licenses and deep knowledge to make lipid conjugates, that could be utilized for active targeting.
For passive targeting, we offer PEGylated lipids that could be used for long circulating liposomes.