Speaker Q&A: What Breaks First When You Scale Oligos from IND to Commercial?

10:30 am - Wednesday 19th August 2026

  • Which early-stage assumptions around CPPs and impurity control most commonly fail at commercial scale?
  • How to predict the point where oligo impurity complexity outpaces the existing analytical control strategy?
  • What elements of process design, raw material qualification, or method validation are most frequently reworked post-Phase II, and why?

Speakers:

Senior Engineer - Process Development & Scale up Lab
Amgen Inc.