Development of a Venofer AUC Analysis protocol and comparison between Venofer and Biosimilar


  • The study aimed to develop an Analytical Ultracentrifugation (AUC) protocol to compare commercial Venofer with a Biosimilar candidate in alignment with the FDA's guidelines on Iron Sucrose.
  • Challenges faced included the high sucrose concentration in the buffer which can affect sedimentation, the high analyte concentration leading to non-ideality, light scattering affecting optical signals, and rotor speeds affecting diffusion and sedimentation balances.


  • A rotor speed of 13,000 rpm was adopted, which minimized the effects of sucrose gradient formation and achieved a balance between diffusion and sedimentation.
  • Wavelength optimization was conducted, with 300 nm selected for optimal observation, reducing light scattering while maintaining good Xenon lamp efficiency.
  • Different dilutions were tested, and a range of 1:2000 to 1:6000 was found optimal, addressing the issues of concentration-dependent non-ideality.
  • The effects of aging and sonication on the samples were also examined to ensure the validity of the results.


  • A robust AUC protocol was successfully developed to compare Venofer with the Biosimilar candidate.
  • By addressing the inherent challenges of high sucrose and analyte concentrations, light scattering, and rotor speeds, the study ensures accurate, reproducible results that align with FDA guidelines.
  • Future comparisons should utilize this protocol for consistent results.
Comparability Studies
Material Science (metal nanoparticles, synthetic polymers, drug compounds)

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