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.