Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
5
pubmed:dateCreated
2004-4-6
pubmed:abstractText
Recombinant Factor VIII (rFVIII) and alpha-amylase were used as model proteins to examine the effect of freeze-drying process conditions on the long-term stability of these proteins as freeze-dried solids. The same sucrose/glycine formulation was used for all treatments. Three freeze-drying protocols were used-an "aggressive" and a "conservative" cycle that both produced pharmaceutically acceptable product, and a protocol that produced a collapsed matrix. For rFVIII, there was no difference in the biological activity versus the time profile for product freeze-dried under the three different conditions when stored at 5 or 25 degrees C. At 40 degrees C, however, the stability of the collapsed product appeared to be better than that of product freeze-dried with no collapse. Also, the level of residual moisture in the collapsed product was higher than that of the product with no collapse. For alpha-amylase, there was no significant difference in the stability profile at any of the temperatures over the time course of the study. The results support the conclusion that collapse is not necessarily detrimental to the long-term stability of freeze-dried proteins.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
May
pubmed:issn
0022-3549
pubmed:author
pubmed:copyrightInfo
Copyright 2004 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 93:1253-1263, 2004
pubmed:issnType
Print
pubmed:volume
93
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
1253-63
pubmed:dateRevised
2008-11-21
pubmed:meshHeading
pubmed:year
2004
pubmed:articleTitle
Effect of collapse on the stability of freeze-dried recombinant factor VIII and alpha-amylase.
pubmed:affiliation
Process and Technology Development, Biological Products, Bayer Corporation, Berkeley, California 94701, USA. dq.wang.b@bayer.com
pubmed:publicationType
Journal Article