A Risk‑Based Strategy for Process Characterization: Integrating Quality by Design, DOE, & Clinical Manufacturing Experience to Deliver a Robust BLA Data Package on an Accelerated Timeline

• Developing risk assessments to justify and guide process characterization strategy
• Designing and executing statistically sound experiments (DOE) to identify critical process parameters (CPPs) and establish Proven Acceptable Ranges (PARs)
• Applying real‑world lessons learned to anticipate challenges and avoid common process characterization pitfalls

Speakers:

Schuyler Mesen

Associate Principal Engineer

Cabaletta Bio