Risk Assessment of Quality Attributes of Synthetic Oligonucleotides Targeted at Silencing Gene Expression

Time: 3:50 pm


  • Assessment of quality attributes of drug substance and drug product for their criticality that are impacted by process and/or its molecular properties that may affect their stability and potency
  • Defining the degradation pathways and thereby monitoring the propensity of formation of different degradants through accelerated stress, short-term and long-term stability studies
  • Develop phase-appropriate stability indicating methods for characterizing the degradants and having process control parameters thereby gaining better understanding of the drug as it progresses to the later phases. Present case studies to explain the process of evaluation of the quality attributes of synthetic oligoribonucleotides