Emily Guinn is an Associate Senior Consultant Engineer in the Particle Design Lab at Eli Lilly. Emily’s work focuses on developing isolation processes for peptides and oligonucleotides. Emily obtained her PhD in physical chemistry from the University of Wisconsin-Madison, where she developed a thermodynamic model to predict effects of solutes on protein and nucleic acid processes. In her postdoctoral work at the University of California-Berkeley, she studied effect of environmental conditions on protein folding thermodynamics and kinetics.
Peptides are an important class of drug molecules due to their involvement in many physiological signaling pathways. However, isolation of peptides is difficult because most peptide isolation options generate amorphous material without the benefits of crystalline structure.
In this presentation, Emily Guinn and Kyle Blakely of Eli Lily discuss the development of a precipitation processes for several therapeutic peptides and the identification of critical risks, including:
- Sticking to the reactor
- Glassing upon isolation
- Poor control of particle size
- Difficulty controlling residual solvents
Development of processes to help mitigate these risks will be discussed including the use of Process Analytical Technology (PAT), in-process microscopy, Focused Beam Reflectance Measurement (FBRM) and Raman spectroscopy to better understand peptide precipitation processes and mitigate the risks posed by these difficulties.
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