@article{oai:repo.qst.go.jp:00085108,
 author = {Hiroki, Matsumoto and Chika, Igarashi and Tomoko, Tachibana and Fukiko, Hihara and Atsuo, Waki and Zhang, Ming-Rong and Sei, Yoshida and Kenichiro, Naito and Hiroaki, Kurihara and Makoto, Ueno and Kimiteru, Ito and Tatsuya, Higashi and Yukie, Yoshii and Hiroki, Matsumoto and Chika, Igarashi and Tomoko, Tachibana and Fukiko, Hihara and Atsuo, Waki and Zhang, Ming-Rong and Tatsuya, Higashi and Yukie, Yoshii},
 issue = {1},
 journal = {Pharmaceutics},
 month = {Jan},
 note = {Objectives: Early diagnosis of pancreatic cancer using current imaging modalities remains challenging. We have developed a new approach to identify the tumor lesions ≥ 3 mm in the pancreas by positron emission tomography (PET) with intraperitoneally administered 64Cu-labeled new anti-epidermal growth factor receptor (EGFR) antibody (encoded as NCAB001), called 64Cu-NCAB001 ipPET. Generally, in clinical research, radiometal-antibody complex must be prepared immediately before use at imaging site. To make 64Cu-NCAB001 ipPET become available to daily clinical practices sustainably, the NCAB001-chelator conjugate and 64Cu-NCAB001 must be characterized and stabilized. Methods: NCAB001 was manufactured under cGMP conditions. The conjugation of NCAB001 with bifunctional chelator (p-SCN-Bn-PCTA) was conducted, and the antibody-chelator conjugate (PCTA-NCAB001) was characterized by LC/MS and ELISA. Thereafter, to manufacture 64Cu-NCAB001 effectively, we developed a new formulation to stabilize the PCTA-NCAB001 and 64Cu-NCAB001. Results. An average of three PCTA chelators were conjugated per molecule of NCAB001. The relative binding potency of PCTA-NCAB001 was comparable to cetuximab. The formulation consisting of acetate buffer, glycine, and polysorbate-80 stabilized the PCTA-NCAB001 for a year-long storage. Additionally, this formulation enabled the stabilization of 64Cu-NCAB001 for up to 24 h after radiolabeling with sufficient radioactivity concentration for clinical use. Conclusion: These results may accelerate the future use of 64Cu-NCAB001 ipPET in the clinical settings for the early diagnosis and treatment of pancreatic cancer.},
 title = {Characterization and stabilization of a new 64Cu-labeled anti-EGFR antibody NCAB001 for the early detection of pancreatic cancer with positron emission tomography},
 volume = {14},
 year = {2022}
}