Lipid Nanoparticle Manufacturing & Formulation |CordenPharma

Lipid Excipients

CordenPharma stands as a global CDMO leader in pioneering specialized lipid-based products for research and pharmaceutical development. With a remarkable track record spanning four decades, CordenPharma has collaborated extensively with the research, pharmaceutical and diagnostic sectors, delivering cutting-edge solutions that push the boundaries of science and contribute to enhancing and saving lives.

Standard Lipids
ADME and DMPK
SORT - Coated LNPs
Blend by Spray Drying
LNP Starter Kits

Standard Lipids

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Lipid excipients are the cornerstone of drug development in a wide variety of therapeutic applications. CordenPharma experts are renowned for contract lipid manufacturing by mastering the total chemical synthesis of complex lipid derivatives from multi-gram to multi-kilogram scale.

Our standard catalog list presents a vast selection of readily available derivatized lipids, pegylated lipids, phospholipids, ionisable & cationic lipids, and BotaniChol^® (cholesterol from plant origin) for purchase in convenient 25 mg to 10 g pack sizes. We are continuously expanding our diverse portfolio of high-purity lipids, which are well-suited for Research & Discovery but representative of commercial-grade material.

ADME and DMPK

Understanding a drug’s ADME (Absorption, Distribution, Metabolism, and Excretion) properties is vital for evaluating its pharmacokinetics and pharmacodynamics, influencing effectiveness and safety.

DMPK (Drug Metabolism & Pharmacokinetics) studies aid in optimizing drug candidates, predicting drug behavior, assessing drug-drug interactions, and establishing dosing regimens. Radio-labeled compounds, particularly labeled lipids like deuterated lipids and dye-conjugated lipids, serve as valuable tools for ADME studies during drug development.

CordenPharma offers specialized lipids to support comprehensive drug development efforts, as well as assist in understanding the behavior of the drug in preclinical studies to optimize its path towards effective and safe human use.

SORT - Coated LNPs

CordenPharma has introduced a methodology known as Selective Organ Targeting (SORT), which involves the systematic engineering of nanoparticles to precisely deliver therapeutic molecules to both hepatic and extrahepatic tissues. These SORT LNPs incorporate an additional lipo-peptide that aids in redirecting LNPs and enhancing cellular uptake in target organs through an inherent targeting mechanism of action.

Blend by Spray Drying

Recent innovations in liposome preparation, such as freeze drying, stable plurilamellar vesicles, and dry, free-flowing granular products, have advanced the field. To address bulk production of liposomes, CordenPharma employs the spray drying technique to stabilize preformed liposomes and their contents during storage. This technique is scalable for bulk preparation of dried lipid mixtures for subsequent liposome production.

With expertise and advanced equipment, CordenPharma provides comprehensive support from early development to commercial production.

LNP Starter Kits

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Lipid NanoParticle (LNP) Starter Kits are important for effective xRNA formulation in the development of xRNA-based therapeutics such as mRNA vaccines or gene therapies. The starter kits provide researchers and developers with the essential components needed to create and optimize their own LNPs for xRNA delivery.

The lipids and ratios involved in our kits are derived from already existing formulations that we have either tested in our LNP formulation facility, or from proven formulations that demonstrate efficiency in clinical trials or commercial applications.

Want to experiment with an immersive liposome lipid bilayer created from our 3D model?

A liposome is a spherical vesicle of concentric self-assembling lipid bilayers. The liposome can be used as a vehicle for administration of pharmaceutical drugs or nutrients.

Liposomes are most often composed of biocompatible and biodegradable lipids excipients such as sphingomyelin, phosphatidylcholine, glycerophospholipids and cholesterols, but may also include other lipids excipients, so long as they are compatible with lipid bilayer structure. Cholesterol, another pharmaceutical additive, can increase stability of a liposome and prevent leakage of a bilayer because its hydroxyl group can interact with the polar heads of the phospholipid bilayer.

Speed to Market
Quality and Compliance
Flexibility and Transparency

Speed to Market

In pharmaceutical development money is time, and time is of the essence. We understand the urgency of producing critical medicines, and are here to support the management of your supply chain timelines, regardless of the development phase.

Our expert teams have decades of experience using cutting-edge technologies across our integrated facility network to help bring your complex modalities to market quickly.

Quality and Compliance

Quality is the most important ingredient for therapeutic effectiveness, and thus, commercial success. Our commitment to seek the highest standards of quality and compliance is at the core of CordenPharma.

By continuing to invest heavily in ongoing compliance programs with budgeted investments in improvements such as compliance-enhancing IT solutions, we make no compromises in this area. Our objective is to not only meet, but surpass applicable regulatory requirements and legislations to provide services that elevate and ensure product integrity for you and the patients you serve.

Flexibility and Transparency

Navigating through your drug development lifecycle can present challenges. CordenPharma understands that a successful CDMO / pharma innovator partnership requires regular touchpoints of insight, feedback and alignment along the way.

With this in mind, we have made a collaborative commitment across the entire organization, from executive leadership and project management teams to facility operators, to react with flexibility and transparency to your changing needs and strive every day to steer your project towards our common goal: the health and well being of your patients.