July 1, 2016 | News & Notices Our paper of monoclonal antibody bioanalysis “nSMOL™” selected as the cover article in Biological and Pharmaceutical Bulletin.

Our paper, Noriko Iwamoto et al., Technology Research Laboratory, SHIMADZU Corporation, has been selected as the cover article in Biological and Pharmaceutical Bulletin, vol.39, No.7 of The Pharmaceutical Society of Japan.
This report is one of the collaboration studies of National Cancer Center in Japan.

We have reported the novel method, nSMOL™ (nano-surface and molecular orientation limited) proteolysis, in 2014. And our group has been continuing the R&D for practical and validated purpose.

We have disclosed the research paper for the validated bioanalysis of monoclonal antibodies using nSMOL™ and LC-MS/MS in accordance with the Guideline on Bioanalytical Method Validation in Pharmaceutical Development from Notification 0711-1 of the Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, the Ministry of Health, Labour and Welfare.

This paper in Biol. Pharm. Bull. indicates the bioanalytical validation of Rituximab, anti-human CD20 chimeric antibody (mouse/human).
We hope to make a contribution to the bioanalysis development in the field of clinical pharmacokinetics and therapeutic drug monitoring by our nSMOL™ strategy independent of a variety of antibodies.

The practical bioanalysis by Fab-selective limited proteolysis. (Reproduced in part with permission from Biol. Pharm. Bull. Vol. 39 No. 7. Copyright 2016 The Pharmaceutical Society of Japan)

Validated LC/MS bioanalysis of Rituximab CDR peptides using nano-surface and molecular-orientation limited (nSMOL) proteolysis.
Noriko Iwamoto, Megumi Takanashi, Akinobu Hamada, and Takashi Shimada
Biol. Pharm. Bull. 2016, vol.39, No.7