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Formulation of Neulasta (pegfilgrastim).

Deirdre Murphy Piedmonte1, Michael J Treuheit

  • 1Department of Pharmaceutics, Amgen Incorporated, One Amgen Center Drive, Thousand Oaks, CA 91320 USA.

Advanced Drug Delivery Reviews
|September 8, 2007
PubMed
Summary

Neulasta (pegfilgrastim) formulation development and stability studies show it is stable for two years when stored at 2-8 degrees C. This PEGylated protein therapeutic maintains integrity under various stress conditions.

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Area of Science:

  • Biopharmaceutical Formulation Development
  • Protein Stability Analysis
  • Analytical Chemistry

Background:

  • Neulasta (pegfilgrastim) is a PEGylated derivative of Filgrastim, designed for enhanced therapeutic properties.
  • Understanding the stability profile of Neulasta is crucial for its successful formulation and long-term storage.
  • Previous research focused on Filgrastim, necessitating specific studies for the PEGylated version.

Purpose of the Study:

  • To detail the formulation development process for Neulasta (pegfilgrastim).
  • To evaluate the stability of Neulasta (pegfilgrastim) under various stress conditions, including pH, temperature, and mechanical stress.
  • To identify optimal formulation parameters ensuring long-term stability and product integrity.

Main Methods:

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  • Formulation development involving systematic variation of pH, protein concentration, buffer type, tonicity modifiers, and surfactant concentration.
  • Stability assessment under accelerated conditions (elevated temperature) and long-term quiescent storage (2-8 degrees C).
  • Evaluation of stability against agitation and multiple freeze-thaw cycles using analytical techniques to monitor degradation.

    • Main Results:

    • The optimal formulation for Neulasta (pegfilgrastim) was determined to be 10 mg/mL protein concentration in 10 mM acetate buffer at pH 4.0.
    • This formulation includes 5% sorbitol as a tonicity modifier and 0.004% polysorbate 20 as a surfactant.
    • Neulasta (pegfilgrastim) in this specific formulation demonstrated stability for up to two years when stored at refrigerated temperatures (2-8 degrees C).

    Conclusions:

    • The developed Neulasta (pegfilgrastim) formulation is robust and stable under recommended storage conditions.
    • The study provides critical data supporting the two-year shelf-life of Neulasta (pegfilgrastim) at 2-8 degrees C.
    • The analytical methods employed are effective in monitoring the stability and degradation pathways of PEGylated proteins.