Your browser doesn't support javascript.
loading
The Production, Quality Control, and Characterization of ZED8, a CD8-Specific 89Zr-Labeled Immuno-PET Clinical Imaging Agent.
Gill, Herman; Seipert, Richard; Carroll, Vincent M; Gouasmat, Alexandra; Yin, Jian; Ogasawara, Annie; de Jong, Isabella; Phan, Minh Michael; Wang, Xiangdan; Yang, Jihong; Ilovich, Ohad; Marik, Jan; Williams, Simon-Peter.
Afiliación
  • Gill H; Genentech Research and Early Development, South San Francisco, California, USA. hermang@gene.com.
  • Seipert R; Genentech Pharmaceutical Technical Development, South San Francisco, California, USA.
  • Carroll VM; inviCRO, Boston, Massachusetts, USA.
  • Gouasmat A; inviCRO, Boston, Massachusetts, USA.
  • Yin J; Genentech Pharmaceutical Technical Development, South San Francisco, California, USA.
  • Ogasawara A; Genentech Research and Early Development, South San Francisco, California, USA.
  • de Jong I; Genentech Pharmaceutical Technical Development, South San Francisco, California, USA.
  • Phan MM; Genentech Research and Early Development, South San Francisco, California, USA.
  • Wang X; Genentech Research and Early Development, South San Francisco, California, USA.
  • Yang J; Genentech Research and Early Development, South San Francisco, California, USA.
  • Ilovich O; inviCRO, Boston, Massachusetts, USA.
  • Marik J; Genentech Research and Early Development, South San Francisco, California, USA.
  • Williams SP; Genentech Research and Early Development, South San Francisco, California, USA.
AAPS J ; 22(2): 22, 2020 01 03.
Article en En | MEDLINE | ID: mdl-31900688
Immuno-PET is a molecular imaging technique utilizing positron emission tomography (PET) to measure the biodistribution of an antibody species labeled with a radioactive isotope. When applied as a clinical imaging technique, an immuno-PET imaging agent must be manufactured with quality standards appropriate for regulatory approval. This paper describes methods relevant to the chemistry, manufacturing, and controls component of an immuno-PET regulatory filing, such as an investigational new drug application. Namely, the production, quality control, and characterization of the immuno-PET clinical imaging agent, ZED8, an 89Zr-labeled CD8-specific monovalent antibody as well as its desferrioxamine-conjugated precursor, CED8, is described and evaluated. PET imaging data in a human CD8-expressing tumor murine model is presented as a proof of concept that the imaging agent exhibits target specificity and comparable biodistribution across a range of desferrioxamine conjugate loads.
Asunto(s)
Palabras clave
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Radioisótopos / Circonio / Leucemia de Células T / Linfocitos T CD8-positivos / Radiofármacos / Tomografía de Emisión de Positrones / Imagen Molecular / Anticuerpos Monoclonales Tipo de estudio: Guideline / Prognostic_studies Límite: Animals / Female / Humans Idioma: En Revista: AAPS J Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2020 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Radioisótopos / Circonio / Leucemia de Células T / Linfocitos T CD8-positivos / Radiofármacos / Tomografía de Emisión de Positrones / Imagen Molecular / Anticuerpos Monoclonales Tipo de estudio: Guideline / Prognostic_studies Límite: Animals / Female / Humans Idioma: En Revista: AAPS J Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2020 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos