Module 9 2021

Module 3 structure may vary with the product

In-vivo transduction

Part S

Part P

2.1.S.2.3

2.1.P

2.1.S.2 & 2.1.S.4

= Viral vector

Viral vector in final formulation medium and container for administration =

Packaging cell bank

Drug Substance

Drug Product

Vector

+

+ Target Cells

= Transduced cells

=

Plasmids

Transduced cells in final formulation medium and container for administration

IMPD – MODULE 3

2.1.S.2.3

2.1.S.2 & 2.1.S.4

2.1.P

Part P

Part S

Ex-vivo transduction

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

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