Lipid NanoParticles (LNP) for mRNA Formulation

LNP Formulation Services

Comprehensive Lipid NanoParticle Formulation Development & Commercialization

Delivering the capabilities pharma needs to support its drug strategies, CordenPharma offers advanced LNP formulation technologies and forward-integrated sterile injectable manufacturing services to create a proven commercialization pathway.

We support requirements for Pre-filled Syringes (PFS), Vials, Ampoules and Lyophilized Vials, with a wide range of filling volumes and secure supply with highly compatible excipients and reliable synthesis.

Our cGMP processing and manufacturing strategies are based on ethanol injection, including in‐line T‐junction mixing (used to mix an organic and aqueous phase in a controlled manner) as well as a microfluidic mixing method.

These methods work using the same principle for the formation of LNPs:

  • >> Formed by a quick increase in polarity of the environment induced by rapid mixing of the two miscible phases. This rapid mixing induces supersaturation of lipid molecules.
  • >> Self‐assemble into the desired structure without the need for size‐reduction methods.

Creating Better Lipid NanoParticles for Vaccine Innovation

Lipid NanoParticles are liposome-like structures composed primarily of cationic lipids, along with other lipid ingredients. These typically include neutral phospholipid molecules especially geared towards encapsulating a broad variety of genetic payloads:

  • >> DNA-RNA based nucleic acids
  • >> siRNA, mRNA and saRNA
  • >> CRISPR / Cas9 genome‐editing

The Essentials to mRNA Development & Delivery

Proven essential to the safe, effective delivery of COVID-19 vaccines and other mRNA / xRNA-based Drug Products, our LNP Formulation services form mRNA delivery systems that help efficiently express the mRNA-encoded immunogen after intramuscular injection. A key player in the therapeutic performance of mRNA-based vaccines, Lipid NanoParticles support efficacy, potency, and vaccine reactogenicity.

LNPs are excellent drug delivery vehicles for transporting the therapeutic cargo of interest within a protective, outer layer of lipids, and can take a wide variety of forms in application.

Proven LNP Formulation & Commercialization Pathway

To enable the capabilities pharma needs to support today’s mRNA and any other x-RNA drug strategies, CordenPharma continues to invest in advanced LNP formulation technologies and sterile injectable manufacturing services:

  • >> Expanded R&D laboratory LNP Formulation & Analytical Characterization capabilities
  • >> Flexible & scalable cGMP LNP Formulation for clinical to commercial supply
  • >> Fully approved Sterile Injectable manufacturing site able to produce Drug Products from clinical to commercial stage

Integrated Sterile Injectable Drug Product Manufacturing

CordenPharma’s Injectable manufacturing services at CordenPharma Caponago cover both Terminal Sterilization and Aseptic Filling Technologies for Pre-filled Syringes (PFS), Vials, Ampoules and Lyophilized Vials, with a wide range of filling volumes. We offer a full range of capabilities including formulation development, manufacturing, clinical trials management (clinical trial kits preparation, randomization & logistics), and packaging.

Integrated Supply of Standard & Custom Lipids for Formulation Services

Standard Lipid Excipients Ideally Suited for mRNA-Based Delivery

CP BotaniChol®

We have developed a straightforward, short synthesis of highly pure plant-derived cholesterol called BotaniChol® used in the production of lipids for mRNA vaccines.

In addition, our standard phosphocholines, PEGylated and cationic lipids nicely complete our lipid offering for global partners involved in mRNA and other RNA-based drug development.

Other Key Standard Lipids ideally suited for mRNA applications:

View our list of standard lipids applicable for mRNA formulation & delivery.

Custom Lipids to Enable & Secure Your xRNA Development Supply Chain

We are experts in synthetic custom lipid process development, scale-up and large-scale manufacturing, enabling you to optimize your LNP formulation, as well as secure your long-term supply chain.

  • >> Drug Master Files (DMFs) for a range of custom lipids including Glycero-Phospholipids, Sphingolipids, Phosphocholines, Pegylated, and Cationic Lipids
  • >> Contact us to quote on development programs for innovative lipid design and development, as well as the large-scale manufacturing of high purity custom lipids

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