2006
DOI: 10.1007/s00216-006-0855-x
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Impact of residual moisture and formulation on Factor VIII and Factor V recovery in lyophilized plasma reference materials

Abstract: Residual moisture content and formulation are important parameters when preparing lyophilized reference materials containing labile proteins. The protection of Factor VIII and Factor V activities were monitored in a lyophilized plasma preparation following formulation with either no additional excipient, 40 mM Hepes (4-(2-hydroxyethyl)piperazine-1-ethanesulfonic acid), 10 mg/mL glycine or a combination of 40 mM Hepes and 10 mg/mL glycine. The preservation of Factor VIII activity during freeze-drying was improv… Show more

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Cited by 11 publications
(8 citation statements)
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“…Plastic microtubes showed an increase in moisture content on storage and a significant loss of FVIII activity. The impact of moisture content and formulation on FVIII stability has also previously been shown [10]. This also suggests that the issue lies with the integrity of the seal/closure.…”
Section: Discussionmentioning
confidence: 70%
“…Plastic microtubes showed an increase in moisture content on storage and a significant loss of FVIII activity. The impact of moisture content and formulation on FVIII stability has also previously been shown [10]. This also suggests that the issue lies with the integrity of the seal/closure.…”
Section: Discussionmentioning
confidence: 70%
“…However, the formulation with glycine and Hepes had least change in activity compared to other formulations studied. [74] Evaluating effect of solvent/ detergent treatment and lyophilization in proteome of plasma 2D gel electrophoresis and mass spectrometry were used to identify proteins.…”
Section: Description Of Study Parameters Considered Resultsmentioning
confidence: 99%
“…Residual moisture required for stability differs from protein to protein and thus secondary drying time also varies. [3133] In case of catalase formulations, after completion of 7 h secondary drying, all samples were found to contain residual moisture in the range of 1-2% (w/w).…”
Section: Resultsmentioning
confidence: 99%