Learning Relationships Between Chemical and Physical Stability for Peptide Drug Development.

Journal: Pharmaceutical research
Published Date: Feb 16, 2023

Abstract

PURPOSE OR OBJECTIVE: Chemical and physical stabilities are two key features considered in pharmaceutical development. Chemical stability is typically reported as a combination of potency and degradation product. Moreover, fluorescent reporter Thioflavin-T is commonly used to measure physical stability. Executing stability studies is a lengthy process and requires extensive resources. To reduce the resources and shorten the process for stability studies during the development of a drug product, we introduce a machine learning-based model for predicting the chemical stability over time using both formulation conditions as well as aggregation curves.

Authors

  • Jonathan Fine
    Department of Chemistry, Purdue University 560 Oval Drive West Lafayette IN USA hilkka@purdue.edu gchopra@purdue.edu.
  • Prageeth R Wijewardhane
    Department of Chemistry, Purdue University, West Lafayette, IN, USA.
  • Sheik Dawood Beer Mohideen
    Department of Chemistry, Purdue University, West Lafayette, IN, USA.
  • Katelyn Smith
    Analytical Research & Development, MRL, Merck & Co., Inc., Rahway, NJ, USA.
  • Jameson R Bothe
    Analytical Research & Development, MRL, Merck & Co., Inc., Rahway, NJ, USA.
  • Yogita Krishnamachari
    Sterile and Specialty Products, Pharmaceutical Sciences, MRL, Merck & Co., Inc., Rahway, NJ, USA.
  • Alexandra Andrews
    Analytical Research & Development, MRL, Merck & Co., Inc., Rahway, NJ, USA.
  • Yong Liu
    Department of Critical care medicine, Shenzhen Hospital, Southern Medical University, Guangdong, Shenzhen, China.
  • Gaurav Chopra
    Department of Chemistry, Purdue University 560 Oval Drive West Lafayette IN USA hilkka@purdue.edu gchopra@purdue.edu.

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