Effect of X-ray radiation exposure on lyophilized recombinant activated factor VII (formulated for storage at room temperature)

Abstract

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, Bagsværd, Denmark) lyophilized using in vitro study methodology, thus evaluating possible effects of exposure through airport security and airplane travel.

Research design and methods:

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

Main outcome measure:

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.

Conclusion:

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.

Key words: :

• Hemophilia
• NovoSeven RT
• Recombinant factor VIIa
• Stability
• X-ray radiation

Transparency

Declaration of funding

This study was funded by Novo Nordisk A/S.

Declaration of financial/other relationships

S.V., H.N., M.W.K., J.B., and A.M.N. have disclosed that they are all full-time employees of, and shareholders in Novo Nordisk. O.J. has disclosed that she is a full-time employee of Novo Nordisk.

Acknowledgments

The authors thank Soon Hatting Skibsted, Employees of Biopharm MDev API and DP Support, Novo Nordisk A/S, Gentofte, Denmark, the Factor VII QC Laboratory for technical assistance. This work, and editorial support from Emma Campbell and Janet Stephenson of Bioscript Stirling Ltd., London, United Kingdom, was funded by Novo Nordisk A/S.

Notes

*Trademark: NovoSeven RT in the United States, Australia and Turkey, and NovoSeven in Europe and other countries (Novo Nordisk A/S, Bagsværd, Denmark).