Vacuum Induced Surface Freezing as an effective method for improved inter- and intra-vial product homogeneity

Author:

Arsiccio AndreaORCID,Barresi Antonello,De Beer Thomas,Oddone Irene,Van Bockstal Pieter-JanORCID,Pisano RobertoORCID

Publisher

Elsevier BV

Subject

Pharmaceutical Science,General Medicine,Biotechnology

Reference61 articles.

1. The freezing step in lyophilization: Physico-chemical fundamentals, freezing methods and consequences on process performance and quality attributes of biopharmaceuticals;Kasper;Eur. J. Pharm. Biopharm.,2011

2. The importance of freezing on lyophilization cycle development;Patapoff;BioPharm,2002

3. The impact of the freezing stage in lyophilization: Effects of the ice nucleation temperature on process design and product quality;Pikal;Am. Pharm. Rev.,2002

4. The ice nucleation temperature determines the primary drying rate of lyophilization for samples frozen on a temperature-controlled shelf;Searles;J. Pharm. Sci.,2001

5. Department of health and human services, US FDA, pharmaceutical cGMPs for the 21st century: A risk-based approach, August 2002.

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