Primary Container Closure System Selection for Lyophilized Drug Products

Author:

Ovadia Robert,Lam Phillippe,Roehl Holger,Janssen Renaud,Asselta Roger

Publisher

Springer International Publishing

Reference58 articles.

1. Pikal MJ, Roy ML, Shah S. Mass and heat transfer in vial freeze-drying of pharmaceuticals: role of the vial. J Pharm Sci. 1984;73

2. Pikal MJ, Shah S. Moisture transfer from stopper to product and resulting stability implications. Dev Biol Stand. 1991;74:165–79.

3. Sreedhara A, et al. Challenges of using closed system transfer devices with biological drug products: an industry perspective. J Pharm Sci. 2020;109:22–9.

4. Ward K, Matejtschuk P, editors. Lyophilization of pharmaceuticals and biologicals: new technologies and approaches. New York: Humana Press/Springer; 2019.

5. Rey L, May JC. Freeze drying/lyophilization of pharmaceutical and biological products. 3rd ed. New York: Informa Healthcare; 2016.

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