Sensitivity Study to Assess the Robustness of Primary Drying Process in Pharmaceutical Lyophilization

Author:

Adhikari Nirajan,Zhu Tong,Jameel Feroz,Tharp Ted,Shang Sherwin,Alexeenko Alina

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference14 articles.

1. Robustness testing in pharmaceutical freeze-drying: inter-relation of process conditions and product quality attributes studied for a vaccine formulation;Schneid,2011

2. Effect of product temperature during primary drying on the long-term stability of lyophilized proteins;Passot;Pharm Dev Technol,2007

3. Design space development for lyophilization using DOE and process modeling;Sundaram;Biopharm Int,2010

4. Freeze-drying simulation framework coupling product attributes and equipment capability: toward accelerating process by equipment modifications;Ganguly;Eur J Pharm Biopharm,2013

5. Quality by design in freezedrying: cycle design and robustness testing in the laboratory using advanced process analytical technology;Gieseler;Pharm Technol,2008

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1. Process development and quality attributes for the freeze-drying process in pharmaceuticals, biopharmaceuticals and nanomedicine delivery: a state-of-the-art review;Future Journal of Pharmaceutical Sciences;2023-11-07

2. Lyophilization scale-up to industrial manufacturing: A modeling framework including probabilistic success prediction;Chemical Engineering Research and Design;2023-04

3. LyoPRONTO: Deterministic and Probabilistic Modeling – Tutorial and Case Study;Principles and Practices of Lyophilization in Product Development and Manufacturing;2023

4. Lyophilization Process Understanding and Scaleup Using Ab Initio Vial Heat Transfer Modeling;Principles and Practices of Lyophilization in Product Development and Manufacturing;2023

5. Experimental and stochastic analysis of lyophilisation;European Journal of Pharmaceutics and Biopharmaceutics;2021-02

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