Effect of X-ray radiation exposure on lyophilized recombinant activated factor VII (formulated for storage at room temperature).
OBJECTIVE
To investigate effects of air transport and X-ray radiation exposure through airport security of a new room temperature-stable rFVIIa formulation (NovoSeven/NovoSeven RT, Novo Nordisk A/S, Bagsvaerd, Denmark) lyophilized using in vitro study methodology, thus evaluating possible effects of exposure through airport security and airplane travel.


METHODS
The effect of X-ray radiation exposure of rFVIIa and the solvent histidine at two different doses (400 microSv and 2000 microSv) was examined immediately after exposure, and post-exposure after storage at 30 degrees C for 1 month. References samples, not exposed to X-ray radiation, were used for comparison.


METHODS
Stability of rFVIIa after X-ray radiation exposure.


RESULTS
All product parameters analyzed were within the acceptance criteria as well as within shelf life specification limits for the selected parameters for each product.


CONCLUSIONS
The product rFVIIa and solvent histidine are therefore not expected to be affected as a consequence of airplane traveling and X-ray exposure during airport security check using hand luggage scanners.
Vestergaard
Susanne
S
Novo Nordisk A/S, Hagedornsvej, Gentofte, Denmark. suve@novonordisk.com
Nedergaard
Hanne
H
Jonasdottir
Oktavia
O
Wagner Kristiansen
Morten
M
Mette Nøhr
Anne
A
Bjerre
Jens
J
D002626:Chemistry, Pharmaceutical / Q000379:methods; D004355:Drug Stability; D004356:Drug Storage / Q000379:methods; D015942:Factor VIIa / Q000737:chemistry / Q000528:radiation effects*; D005612:Freeze Drying; D006801:Humans; D011994:Recombinant Proteins / Q000737:chemistry / Q000528:radiation effects; D013696:Temperature; D014186:Transportation; D014965:X-Rays / Q000009:adverse effects
D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa