Connect Conference & Show Floor Educational Sessions

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  • Drug Product Development and Biophysical Characterization of Protein Therapeutics

    • Haripada Maity Ph.D.  |  Research Advisor, Formulation Development, CMC Development, Eli Lilly and Company
    • Arvind Srivastava Ph.D.  |  Research Advisor, Formulation Development, CMC Development, Eli Lilly and Company
    Location:  113B
    Track: Drug Development
    Pass Type: Connect Delegate, VIP Attendee - Get your pass now!
    Vault Recording: TBD

    Protein instability may occur at different stages of development, including bioprocessing, purification, formulation, and during storage and delivery. Enthalpy-entropy compensation makes protein structure to be marginally stable and it is stabilized by higher enthalpic contribution to the free energy of unfolding. A major physical degradation pathway of a therapeutic protein during its life cycle is aggregation which strongly depends on both conformational (thermodynamic) and colloidal stabilities. Higher free energy of unfolding corresponds to higher conformational stability and higher colloidal stability of a protein solution corresponds to higher protein-protein repulsive electrostatic interactions compared to attractive interactions (Derjaguin-Landau-Verwey-Overbeek theory). The primary objective of a robust formulation development is to reduce the rate of change of both physical and chemical degradation of a protein by optimizing conformational and colloidal stabilities. Uncluttered experimental strategy using both biophysical and analytical methods and correct understanding of complex data are critical for optimal formulation development and characterization of proteins. In addition, dosage form selection, container closure integrity, and in-use stability are critical for the overall drug product development.

    This presentation will address the following:
    • Stability challenges in protein therapeutics
    • Rational formulation development strategy
    • Selection of biophysical and analytical methods
    • Utility of these multidimensional approaches and the connectivity of these data in terms of thermodynamic/conformational stability and kinetic stability of protein.
    • Characterization of Higher Order Structure (HOS) and its effect on protein stability
    • Dosage form selection
    • Container closure selection and drug wastage
    • Temperature excursion
    • In-use stability