Assessing the Impact of Charge Variants on Stability and Viscosity of a High Concentration Antibody Formulation.

@article{Sule2017AssessingTI,
  title={Assessing the Impact of Charge Variants on Stability and Viscosity of a High Concentration Antibody Formulation.},
  author={Shantanu V Sule and Jason E Fernandez and Vincent J Mecozzi and Yana Kravets and William C Yang and Pamela Feng and Suli Liu and Li Zang and Allan D. Capili and Tia B Estey and Kapil Gupta},
  journal={Journal of pharmaceutical sciences},
  year={2017},
  volume={106 12},
  pages={
          3507-3514
        }
}
Characterizing molecular charge variants or isoforms is essential for understanding safety, potency, and bioavailability of antibody therapeutics. However, there is little information on how they influence stability and viscosity-properties governing immunogenicity and delivery. To bridge this gap, we studied antibody stability as a function of charge variant content generated via bioreactor process. We were able to systematically vary acidic variant levels as a function of bioreactor harvest… CONTINUE READING