Quality by Design in the Secondary Drying Step of a Freeze-Drying Process
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چکیده
منابع مشابه
Freeze-drying Process Development for Protein Pharmaceuticals
This chapter provides an overview of the impact of protein formulation variables on different stages of the protein freeze-drying process and offers guidance for selection of critical process parameters during protein freeze-drying cycle development, optimization, and scale-up. There is particular focus on practical considerations including large-scale process development, scale-up challenges, ...
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1. Freezing: the product to be dried is put over shelves in a chamber and its temperature is lowered so that the water (or the other solvent) is frozen. Unfortunately, not all the solvent freezes forming ice crystals, but a certain amount (sometimes significant) remains bonded to the product and must be finally desorbed. In some cases the product (the drug and the excipients) does not crystalli...
متن کاملCirculating-Gas Freeze Drying
WAGMAN, JACK (U.S. Army Biological Laboratories, Frederick, Md.) AND EDWARD J. WENECK. Preservation of bacteria by circulating-gas freeze drying. Appl. Microbiol. 11:244-248. 1963.-Water-washed Serratia marcescens and Escherichia coli were freeze dried in a circulating-gas system at atmospheric pressure. This convective procedure resulted in a substantially higher survival of organisms than cou...
متن کاملPreservation of enteroviruses by freeze-drying.
A method was developed for freeze-dry stabilization of poliovirus type 3. An ultrafiltration procedure was used to remove salts from infected tissue culture fluid, and the virus was freeze-dried after suspension in an alkaline organic buffer. This method was further tested with other picornaviruses including poliovirus types 1 and 2, coxsackieviruses A9, A20, B2, and B5, echovirus 11, and the e...
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Transplantation brings hope for many patients. A multidisciplinary approach on this field aims at creating biologically functional tissues to be used as implants and prostheses. The freeze-drying process allows the fundamental properties of these materials to be preserved, making future manipulation and storage easier. Optimizing a freeze-drying cycle is of great importance since it aims at red...
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ژورنال
عنوان ژورنال: Drying Technology
سال: 2012
ISSN: 0737-3937,1532-2300
DOI: 10.1080/07373937.2012.704466