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View More Analytical Methods BioBusiness Cell Culture/Fermentation Continuous Processing Drug Delivery Fill/Finish Formulation Process Chromatography Process Control/PAT Process Development QA/QC Separation and Purification Single-Use Systems Supply Chain

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COVID-19 Update
Analytics
Development
Downstream Processing
Manufacturing
Outsourcing
Quality/GMPs
Upstream Processing

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Analytical Methods
BioBusiness
Cell Culture/Fermentation
Continuous Processing
Drug Delivery
Fill/Finish
Formulation
Process Chromatography
Process Control/PAT
Process Development
QA/QC
Separation and Purification
Single-Use Systems
Supply Chain

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Simona Bertolini

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Simona Bertolini is in R&D CMC at Chiesi and is a member of the AFI process validation working group.

Articles

Enhancing Process Validation for Sterile Liquid and Freeze-Dried Forms

AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.