PMID- 19041094
OWN - NLM
STAT- MEDLINE
DCOM- 20090512
LR  - 20191210
IS  - 1873-3778 (Electronic)
IS  - 0021-9673 (Linking)
VI  - 1216
IP  - 13
DP  - 2009 Mar 27
TI  - Rapid high-performance liquid chromatographic analysis of adenovirus type 5 
      particles with a prototype anion-exchange analytical monolith column.
PG  - 2725-9
LID - 10.1016/j.chroma.2008.11.010 [doi]
AB  - To support effective process development there is a requirement for rapid 
      analytical methods that can identify and quantitate adenoviral particles 
      throughout the manufacturing process, from cellular lysate through to purified 
      adenovirus. An anion-exchange high-performance liquid chromatography method for 
      the analysis of adenovirus type 5 (Ad5) particles has been developed using a 
      novel quaternary amine monolithic column (Bio-Monolith QA, Agilent). The 
      developed method separates intact Ad5 from contaminating proteins and DNA, thus 
      allowing analysis of non-purified samples during process development. 
      Regeneration conditions were incorporated to extend the functional life of the 
      column. Once developed, the method was qualified according to performance 
      criteria of repeatability, intermediate precision and linearity. The linear 
      working range of analysis was established between 7.5 x 10(8) to at least 2.4 x 
      10(10) viral particles (3 x 10(10) to 9.6 x 10(11) viral particles/mL), with a 
      correlation coefficient of 0.9992. Relative standard deviations (RSDs) for intra- 
      and inter-day repeatability and precision for retention time and peak area were 
      less than 1 and 2.5%, respectively.
FAU - Whitfield, Robert J
AU  - Whitfield RJ
AD  - Eden Biodesign Ltd., National Biomanufacturing Centre, Estuary Business Park, 
      Liverpool, UK.
FAU - Battom, Suzanne E
AU  - Battom SE
FAU - Barut, Milos
AU  - Barut M
FAU - Gilham, David E
AU  - Gilham DE
FAU - Ball, Philip D
AU  - Ball PD
LA  - eng
PT  - Journal Article
PT  - Validation Study
DEP - 20081111
PL  - Netherlands
TA  - J Chromatogr A
JT  - Journal of chromatography. A
JID - 9318488
SB  - IM
MH  - Adenoviridae/*isolation & purification
MH  - Cell Line
MH  - Chromatography, High Pressure Liquid/*methods
MH  - Chromatography, Ion Exchange/*methods
MH  - Humans
MH  - Virion/*isolation & purification
EDAT- 2008/12/02 09:00
MHDA- 2009/05/13 09:00
CRDT- 2008/12/02 09:00
PHST- 2008/09/06 00:00 [received]
PHST- 2008/11/02 00:00 [revised]
PHST- 2008/11/04 00:00 [accepted]
PHST- 2008/12/02 09:00 [pubmed]
PHST- 2009/05/13 09:00 [medline]
PHST- 2008/12/02 09:00 [entrez]
AID - S0021-9673(08)01964-X [pii]
AID - 10.1016/j.chroma.2008.11.010 [doi]
PST - ppublish
SO  - J Chromatogr A. 2009 Mar 27;1216(13):2725-9. doi: 10.1016/j.chroma.2008.11.010. 
      Epub 2008 Nov 11.