Selection of Isolation Process for Drug Substance for Peptides & Oligonucleotides Using a Six-Sigma Approach

Time: 2:00 pm
day: Day One


  • Assessing current oligonucleotide and peptide DS isolation form selection strategies – based on available options at various CMOs
  • Challenges selecting fastest possible and lowest cost option during DS scale-up and DP manufacturing
  • Changes to isolation form during late stages of development leads to comparability challenges between DS forms and consequently for DP process
  • Utilizing different selection strategies through a systemic approach and phase appropriate decision making process to reduce challenges for DS scale-up, DP manufacturing and comparability risk