Formulations


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

Let us help you do amazing things with our lipids!

The product development cycle generally has the following steps prior to product launch.

  • Technology Transfer
    Liposome with an API in its aqueous core
  • Formulation Screening and Optimization
  • R&D Material Production
  • Process Development and Scale-up
  • Production of Clinical Materials
  • Further Process Scale-up and Optimization
  • Manufacturing of Commercial-scale Bulk Product

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 Formulations Team has considerable experience working with Avanti lipids to produce lipid formulations 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 lipid-based drug delivery system 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 formulation expertise and assist in the design of lipid-based formulations
  • Provide the full Avanti lipid catalog for custom formulations as small as 25 mg
  • Provide custom synthesis of lipids for your formulation
  • Make custom lipid formulations to meet your specifications or prepare custom lipid blends
  • Provide lipid-based drug delivery systems that encapsulate, conjugate, or complex APIs, nucleic acids, proteins, and small molecules.
    Microfluidics device
  • Produce 1 mL – 50 L lipid formulations using:
      1. Extrusion
      2. High-pressure Homogenization
      3. Sonication
      4. High-shear Homogenization
      5. Microfluidics


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 – 55 L batches)
  • Manufacture materials for clinical trials in our animal product-free, cGMP adjuvant manufacturing suite
  • Manufacture adjuvant-containing liposomes or nanoparticles in our 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, and regulatory 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 lipid formulation 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 50 years
  • Seamless transition to commercial drug product manufacturing

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