Module 9 2021

Manufacturing

Viral vector based gene therapy

Drug Product

Drug Substance

Ex-vivo gene therapy

Packaging cell thawing

DS thawing

Cell thawing

Packaging Expansion

Positive selection

Pooling

Production phase

Upstream Downstream

Transduction

Bulk harvest

Sterile filtration

Cell expansion

Clarification

Harvest and washes

Drug Product ?

Drug Substance ?

AEC / CEX

Filling

Formulation and filling

Ultra/Diafiltration

DS storage

DP storage

Cryopreservation

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

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