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Cell Therapy Manufacturing

 Philip G. Vanek Ph.D
  28th-Jul-2016
Description: Manufacturing complexity for autologous cells is a challenge to be overcome: Similarities to bioprocess manufacturing: Requires cell culture technology, Regulated as a drug, Manufactured in sterile facilities, Scaled production with automation. Unique to Cell and Gene Therapy (Immunotherapy): Mass customization/ parallel processing, Critical custody management, Care pathways connected to entire process, Flexible factories (multiple products through same/similar line), May persist - potentially curative, Complex distribution driven by product shelf-life.
Views: 1519
Domain: Medical
Category: Biotech/Pharma
Contributing Organization: World Stem Cell Summit
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Contents:
Cell Therapy Manufacturing
Industrial and digital considerations
Philip G. Vanek, Ph.D.
GM Cell Therapy Technologies
GE Healthcare
WSCS15
Atlanta
Imagination at work

Manufacturing Considerations for
Commercialization

1
2

Make sure the biology
works!
Close processing unit
operations

De-risk
Save time
Save materials

3

Physically integrate unit
operations

4

Digitally integrate unit
operation ... See more

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