Freeze-drying/lyophilization of pharmaceutical and biological products.

Author(s) : REY L., MAY J. C.

Type of monograph: Book


The technology of freeze-drying first gained wide application in the food industry, but recent technological advances means that there are now important uses of freeze-drying in the pharmaceutical industry because of the increasing promise of stability of product at the molecular level throughout the entire manufacturing process. This handbook, published in the "Drugs and the pharmaceutical sciences" series, provides state-of-the-art information on freeze-drying using nonaqueous cosolvent systems. Extract from the table of contents: glimpses into the realm of freeze-drying; structural and dynamic properties of bulk and confined water; mechanisms of protein stabilization during freeze-drying and storage; freezing- and drying-induced perturbations of protein structure and mechanisms of protein protection by stabilizing additives; freezing and annealing phenomena in lyophilization; molecular mobility of freeze-dried formulations as determined by NMR relaxation, and its effect on storage stability; formulation characterization; practical aspects; closure and container considerations in lyophilization; critical steps in the preparation of elastomeric closures for biopharmaceutical freeze-dried products; advanced glassware for freeze-drying; development of new concept for bulk freeze-drying; regulatory control of freeze-dried products; freeze-drying of biological standards; industrial freeze-drying for pharmaceutical applications; technical procedures for operation of cleaning-in-place/sterilization-in-place process for production freeze-drying equipment; lyophilization process validation; lyophilizer qualification: some practical advice; some leading edge prospects in lyophilization; irradiation of freeze-dried vaccine and other select biological products.


  • Original title: Freeze-drying/lyophilization of pharmaceutical and biological products.
  • Record ID : 2006-1574
  • Languages: English
  • Publication: Marcel dekker - United kingdom/United kingdom/United states/United states
  • Publication date: 2004
  • Collection:
  • ISBN: 0824748689
  • Source: Source: ed. 2; vol. 137; 613 p. (15.5 x 23.5); fig.; phot.; tabl.; ref.; index; GBP 115.
  • Document available for consultation in the library of the IIR headquarters only.