RT Journal Article
SR Electronic
T1 A Biofunctional Assay to Study pRL-CMV Plasmid DNA Formulation Stability
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 314
OP 317
VO 53
IS 6
A1 Poxon, Scott W.
A1 Hughes, Jeffrey A.
YR 1999
UL http://journal.pda.org/content/53/6/314.abstract
AB The ability of a plasmid DNA formulation to code for a functional protein was assayed as a marker for plasmid DNA stability using a cotransfection method to measure transcription efficiency. This method shows increased sensitivity and reproducibility over single plasmid transfection methods. Method validation, by measuring DNA degradation rates, demonstrates that buffer choice may be of some importance in the pharmaceutical formulation of plasmid DNA. Degradation rates dependant on citrate buffer concentration were observed. This cotransfection method has proven superior to standard agarose gel electrophoresis in quantifying subtle pRL-CMV plasmid DNA damage and could be used to help predict stability of a final plasmid DNA dosage form.