American Pharmaceutical Review (2004) 1-4
Radiosensitivity Study of Freeze-dried Antibodies to Gamma Irradiation
I. Caballero, S. Altanés, A. Castillo, V. Deridder, T. Gomez, Y.
Miralles, V. Naydenov, E. Prieto, B. Tilquin
Center of Melecula Immunolgy, Cuba
Université Catholique de Louvain, Faculté de
Médecine, Bruxelles
Center of Applied Studies to Development of Nuclear Energy, Cuba
Analysis of degradation freeze-dried antibodies by 60 co gamma
irradiation was performed using the UV Scanning Spectroscopy, Gas
Chromatography, High Performance Liquid Chromatography and Electron
Paramagnetic Resonance techniques. The byproducts formed after
irradiation are in very low abundance. They were not detectedeven
when using high sensitivity GC and UV Scannin Spectroscopy. We
also anticipate that the formed byproducts will be similar to the
no-damaged product. The EPR spectra of all monoclonal antibodies
are asymmetric features centered around 332T. The signal
intensity depends on the irradiation dose linearly up to 15kGy, while
at higher doses the linearity disappears apparently by radical
recombination despite the low diffusion properties of the freeze-dried
compounds. The most radiosensitive antibodies were humanized
monoclonal antibodies and the glucose played a radioprotector
role. The HPLC results indicate that it is an adequate technique
to detect the byproducts. The formed radical are very stable and
they can be detected up to nine months.