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GMP grade cationic lipids for Nucleic Acid Delivery

In LNP formulations, cationic ionizable lipids are used to complex negatively charged RNA. Aside from playing a major role in the LNP formulation itself, cationic lipids also serve a major role in the biological administration of RNA to target cells.

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Cationic lipids

As crucial components in LNPs, new cationic ionizable lipids for Nucleic Acid Delivery are being investigated to optimize RNA complexation, endosomal membrane fusion and cargo release into the cytosol.

Cationic ionizable lipids must be engineered with a suitable apparent acid dissociation constant (pKa) in order to facilitate fusion of the LNP with the cell membrane. The apparent pKa of a cationic ionizable lipid is the likely pKa at the LNP surface. Currently, the cationic ionizable lipids in FDA-approved therapeutics all have an apparent pKa between 6-7. This is crucial for the cationic ionizable lipid to maintain a neutral charge while in systemic circulation (pH above the pKa of the lipid, pH ~7.5), as well as its ability to become positively charged in the endosome (pH ~6.5) and facilitate membrane fusion and subsequent cytosolic release.

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Support from concept to commercial

It starts with having the leading lipid technology experts in synthesis and formulation and approaching the discovery process in a collaborative nature, then having the expertise to transfer those learnings into a GMP manufacturing environment to support clinical development. And finally, having the commercial production capability to support launch and commercial supply.

Our full range of services include process chemistry, scale-up manufacturing, supply chain management with analytical and regulatory requirements. Our experienced staff of chemists and lipid analysts are ready to meet your development needs with pre-clinical through phase III and commercial launch, speak to one of our experts today!

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Lipid supporting services

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CDMO cGMP manufacturing

CDMO project management from R&D through to commercialization. Contract manufacturing of proprietary lipid products.
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Custom synthesis

Synthesis of research use materials for a variety of applications. Custom synthesis of reference standards or impurities.
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Formulation

Development of a suitable formulation for lipid-based delivery systems. Custom lipid blends for use in delivery or diagnostic applications.