Lipids for pharmaceutical applications

Merck:/Freestyle/PS-Process-Solutions/SMP-Small-Molecule-Pharmaceuticals/drug-delivery/lipids-graphic.pngYour 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, 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.

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 work with PEG lipids, Lipids for active targeting, and Specialty lipids.

Our 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

PEG Lipids

Both Polyethylene glycol (PEG) and Monomethoxypolyethyleneglycol (MPEG) have been used since many years as non toxic auxiliary material in cosmetics, foodstuffs and pharmaceuticals (FDA accepted).

The conjugation of PEGs or MPEGs with lipids leads to heterobifunctional PEG Lipids resp. MPEG Lipids.

MPEG derived lipids are used to produce PEGylated liposomes. Due to their enhanced stability against blood plasma they are also called Long Circulating Liposomes.

Lipids derived from difunctional PEGs are usually bearing a reactive group on the other end of the PEG chain. This reactive group is used to attach Peptides, Antibodies etc. to the Liposome surface. Such Immunoliposomes are used for cell specific targeting or in vaccines.

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Lipids for 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.

For use with Long Circulating Liposomes (PEGylated) antigen modified PEG-Lipids are needed in order to prevent shielding of the receptor antigen.

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Specialty Lipids

As a highly specialized manufacturer of novel excipients, MilliporeSigma focuses on the tailored manufacturing of synthetic lipids for our customers.

Our portfolio of synthetic lipids includes:

  • Phospholipids
  • Cationic lipids
  • Ionizable lipids
  • PEGylated lipids
  • others

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