The importance of formulation in the successful lyophilization of influenza reference materials.
File(s)
Published version
Author(s)
Duru, C
Swann, C
Dunleavy, U
Mulloy, B
Matejtschuk, P
Type
Journal Article
Abstract
Lyophilized Influenza antigen reference reagents are a critical resource in the quality control of influenza vaccines. A standard formulation has been used successfully at NIBSC for many years however, following the unexpected occurrence of a collapsed appearance in a particular batch a study was carried out to establish the impact of the sugar concentration in the formulation using modulated differential scanning calorimetry (mDSC) and nuclear magnetic resonance spectroscopy (NMR). There was a correlation between the presence and size of the mDSC eutectic temperature events and the freeze dried appearance of the cakes, which became progressively worse with increasing amounts of sugar. NMR spectroscopy could be used to positively identify and quantify the sugars in the formulations. MDSC can rapidly predict if the freeze dried appearance will be acceptable so as to assure the successful lyophilization of influenza reference preparations.
Date Issued
2015-01-20
Date Acceptance
2014-12-10
Citation
Biologicals, 2015, 43 (2), pp.110-116
ISSN
1095-8320
Publisher
Elsevier
Start Page
110
End Page
116
Journal / Book Title
Biologicals
Volume
43
Issue
2
Copyright Statement
Crown Copyright © 2014 Published by Elsevier Ltd on behalf of The International Alliance for Biological
Standardization. This is an open access article under the CC BY-NC-SA license (http://creativecommons.
org/licenses/by-nc-sa/3.0/).
Standardization. This is an open access article under the CC BY-NC-SA license (http://creativecommons.
org/licenses/by-nc-sa/3.0/).
Identifier
PII: S1045-1056(14)00121-3
Subjects
DSC
Formulation
Influenza antigen
Lyophilization
NMR
PBS
Antigens, Viral
Freeze Drying
Humans
Influenza Vaccines
Reference Standards
Publication Status
Published