Abstract
Lyophilization is the process of dehydrating a material at low temperature and reduced pressure. It is used to extend the shelf life of many biologic drug products. This paper discusses two systems essential to these products: container systems and reconstitution (i.e., rehydrating) systems.
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Acknowledgments
Mix2Vial® and MixJect® are registered trademarks of West Pharma. Services IL, Ltd., a subsidiary of West Pharmaceutical Services, Inc. FluroTec®, LyoTec®, LyoSeal®, Verisure®, are trademarks or registered trademarks of West Pharmaceutical Services, Inc. FluroTec® and Daikyo Crystal Zenith® technology are licensed from Daikyo Seiko, Ltd. Daikyo Crystal Zenith® and Plascap® are trademarks or registered trademarks of Daikyo Seiko, Ltd. TopPac® is a registered trademark of Schott AG.
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McAndrew, T.P., Hostetler, D., DeGrazio, F.L. (2019). Container and Reconstitution Systems for Lyophilized Drug Products. In: Ward, K., Matejtschuk, P. (eds) Lyophilization of Pharmaceuticals and Biologicals. Methods in Pharmacology and Toxicology. Humana Press, New York, NY. https://doi.org/10.1007/978-1-4939-8928-7_9
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DOI: https://doi.org/10.1007/978-1-4939-8928-7_9
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Publisher Name: Humana Press, New York, NY
Print ISBN: 978-1-4939-8927-0
Online ISBN: 978-1-4939-8928-7
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