Developing Robust and Scale-able Peptide Isolation Processes
Identify, Understand and Mitigate Risks During Peptide Precipitation
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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About the Presenters
Emily Guinn
Eli Lilly
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.
Kyle Blakely
Eli Lilly
Kyle Blakely is a Consultant Engineer within the Particle Design Lab at Eli Lilly. Kyle earned his bachelor’s degree in chemical engineering magna cum laude from the University of Illinois and then joined Lilly. At Eli Lilly, his responsibilities include both synthetic process and drug product design and development. As a member of the Particle Design Lab, his work focuses on isolation process development, including crystallization process design, particle engineering, techniques for bioavailability improvement of poorly water-soluble drug candidates and isolation of peptides.
