Comparability Assessment Protocols
Source: Cytiva
Certain CMC changes require comparability assessments, others don’t. But if you promise one, regulators will hold you to it whether required or not. In this segment of the Bioprocess Online Live event Regulatory Harmonization Meets CMC Realities, former Pfizer Head of Business Strategy and Operations and current CEO of InScope Coaching & Consulting Steffi Pluschkell, Ph.D. and Alira Health Senior VP of CMC Steven Chamow, Ph.D. discuss when comparability assessments are truly necessitated.
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