Speaker Spotlight: Managing Solid Form Transformation in Drug Product: Analytical & Biopharmaceutical Considerations

Spotlight Speaker(s)

• 

  Umesh Kestur, PhD

  Scientific Director
  Bristol-Myers Squibb Company
  New Brunswick, New Jersey

Moderator(s)

• 

  Amit Tiwari, PhD (he/him/his)

  Professor and Associate Dean
  University of Arkansas for Medical Sciences
  Little Rock, Arkansas

Solid form transformation could occur from use of high energy forms to overcome solubility challenges or stresses from manufacturing processes. Guidelines on how to handle a risk of solid form transformation including test procedures, acceptance criteria and justification of specification is highlighted in the ICH Q6A document. This presentation will use the ICH Q6A guideline as a basis to provide a more comprehensive and actionable workflow to evaluate solid form transformation and help establish a control strategy to maintain drug product quality. The presentation will also highlight transformation risk evaluation methodologies/ tools for different types of transformations. This will include discussion on the pros and cons of different analytical methodologies for detection and quantification of a transformation. Additionally, biopharmaceutical workflow to gauge the level and severity of risk at both the drug substance and drug product stages will be presented. Finally, a few case studies will be discussed that capture how the workflow can be used to manage transformation risk.