The Production, Quality Control, and Characterization of ZED8, a CD8-Specific Zr-Labeled Immuno-PET Clinical Imaging Agent

Overview

Journal AAPS J

Specialty Pharmacology

Date 2020 Jan 5

PMID 31900688

Citations 12

Authors

Herman Gill

Richard Seipert

Vincent M Carroll

Alexandra Gouasmat

Jian Yin

Annie Ogasawara

Isabella de Jong

Minh Michael Phan

Xiangdan Wang

Jihong Yang

Ohad Ilovich

Jan Marik

Simon-Peter Williams

Affiliations

Soon will be listed here.

Abstract

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 Zr-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.

Citing Articles

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