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- W2782906519 abstract "BACKGROUND: To advance 111In-BzDTPA-NLS-trastuzumab to a Phase I/II clinical trial, studies were conducted to develop a kit under GMP conditions to prepare clinical quality 111In-BzDTPA-NLS-trastuzumab injection. METHODS: Trastuzumab was buffer-exchanged into 0.1 M NaHCO3, then reacted with 10-fold molar excess of BzDTPA. The ICs were then buffer-exchanged into 0.1 M NaPO4 with 0.01% PS20. Purified BzDTPA-trastuzumab was reacted with 5-fold molar excess of sulfo-SMCC in 0.1 M NaPO4 with 0.01% PS20. Following re-purification, the ICs were reacted with 60-fold molar excess of NLS peptides. The BzDTPA-NLS-trastuzumab ICs were buffer-exchanged into 0.05 M NH4Ac with 0.01% PS20. Unit dose kits meeting specifications for pharmaceutical quality were prepared. MicroSPECT/CT was performed in mice with SK-OV-3 human ovarian cancer xenografts. RESULTS: Three kits that met specifications for pharmaceutical quality were manufactured. Tumor xenografts were imaged by microSPECT/CT.CONCLUSION: Careful selection of reaction conditions was required to obtain kits that met all specifications.%%%%M.Sc." @default.
- W2782906519 created "2018-01-26" @default.
- W2782906519 creator A5079298811 @default.
- W2782906519 date "2017-06-01" @default.
- W2782906519 modified "2023-09-23" @default.
- W2782906519 title "Formulation of a Kit for the Preparation of 111In-BzDTPA-NLS-trastuzumab Injection under Good Manufacturing Practices (GMP): An Auger Electron-emitting Radioimmunotherapeutic Agent for HER2-positive Breast Cancer" @default.
- W2782906519 hasPublicationYear "2017" @default.
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