Module 9 2021

Starting materials – regulatory landscape

EU regulatory environment (Directive 120/2009 EC, EMA/CAT/671639/2008 rev1)

US regulatory environment

GTMPs: master virus seed or plasmids vector, packaging cells,

Critical components

gene editing tool (Cas9, sgRNA...)

SCBM: structural components, cells

Produced and controlled as an API • GMP production • Cell source and history and generation documented • Method validation • Full details and documentation in the Dossier

Novartis Pharma AG- Business use only- not for further distribution

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