Predictive models of lyophilization process for development, scale-up/tech transfer and manufacturing

Author:

Zhu Tong,Moussa Ehab M.,Witting Madeleine,Zhou DeliangORCID,Sinha Kushal,Hirth Mario,Gastens Martin,Shang Sherwin,Nere Nandkishor,Somashekar Shubha Chetan,Alexeenko Alina,Jameel Feroz

Publisher

Elsevier BV

Subject

Pharmaceutical Science,General Medicine,Biotechnology

Reference28 articles.

1. Freeze drying – principles and practice for successful scale-up to manufacturing;Tsinontides;Int. J. Pharm.,2004

2. An industry perspective on the application of modeling to lyophilization process scale up and transfer;Tchessalov;Am. Pharm. Rev.,2017

3. Heat and mass transfer scale-up issues during freeze-drying, I: Atypical radiation and the edge vial effect;Rambhatla;AAPS PharmSciTech.,2003

4. Heat and mass transfer scale-up issues during freeze-drying, III: Control and characterization of dryer differences via operational qualification tests;Rambhatla;AAPS PharmSciTech.,2006

5. Principles of lyophilization cycle scale-up;Tchessalov;Am. Pharm. Rev.,2007

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