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Formulations

The Avanti Formulations Team can help develop a suitable formulation for your liposome or nanoparticle. With the vast library of Avanti lipids and state-of-the-art equipment at their disposal, our experienced team can produce surface-labeled, PEGylated, fluorescent, and other liposome formulations, while working closely with our Lipid Analysts to ensure Avanti quality.

Let us help you do amazing things with our lipids!

From Research & Discovery > Through Clinical Trials > To Commercialization

The product development cycle generally takes the following path to product launch.

  • Technology Transfer
  • Liposome Development
  • R&D Material Production
  • Process Scale-up
  • Manufacturing of Phase I through III Materials
  • Further Process Scale-up
  • Manufacturing of Commercial-scale Pharmaceuticals

Avanti can assist at any point along this path. Contact our formulation experts to discuss how Avanti can help you translate your product ideas into reality.

At the R&D Stage

The process starts at the R&D stage. Our Formulation Team has considerable experience working with Avanti lipids to produce nanoparticles with the exact properties you need for a successful project. Whether you have developed your own formulation and need help scaling up the process, or you want Avanti to design a nanoparticle to achieve your product goals, we have the capability to design and deliver any formulation imaginable. And if the perfect lipid for your formulation does not currently reside in our extensive catalog, chances are our outstanding lipid synthesis team can prepare it.

R & D Process

  • Offer liposome expertise, free technical consulting, and assist in the design of liposomes
  • Provide the full Avanti lipid catalog for custom formulations as small as 25 mg
  • Provide custom synthesis of lipids for your formulation
  • Make custom liposome formulations to meet your specifications, or prepare custom lipid blends for hydration
  • Produce 0.1 mL – 1 L liposomes and nanoparticles using:
    • Extrusion
    • Emulsification
    • Sonication

At the Clinical Stage

The clinical process starts with the assignment of a dedicated Project Manager, ensuring that your project is completed within your expected timeline. Your Project Manager works in partnership with you through the following process.

Clinical Process

  • Transfer our small-scale manufacturing to larger-scale (1 L – 200 L batches) with minimal process changes
  • Manufacture materials for clinical trials in our animal product-free, cytotoxin-free cGMP manufacturing area
  • Manufacture adjuvant-containing liposomes or nanoparticles by emulsification in our dedicated cGMP adjuvant manufacturing suite
  • Assist in the identification and selection of a sterile-filtration facility for parenteral products
  • Coordinate inter-departmental efforts including analytical method development, qualification and validation, stability protocol, and drug master file support

At the Commercial Stage

Our Formulations Division offers complete product cycle services that support oral formulations for commercial production. For parenteral products, we have established relationships with sterile liposomal product manufacturers for a seamless transfer of your product to aseptic commercial production.

Commercialization Process

  • Scale up manufacturing to support your product needs
  • Promise to give your product the same care that is given to our lipids, still the best in the industry after 46 years
  • Seamless transition to commercial drug product manufacturing

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