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Journal article

Formulation development and manufacturing of a gastrin/CCK-2 receptor targeting peptide as an intermediate drug product for a clinical imaging study.

Abstract:

A DOTA-gastrin analogue (APH070) which, when labelled with (111)In, has high affinity for the gastrin/CCK-2 receptor (3nM) and low tumour to kidney ratio in animal models, has been formulated and manufactured for a clinical study. Oxidation of the peptide methionine residue greatly reduces receptor affinity, therefore development work focused on producing a stable intermediate drug product (iDP) whilst ensuring that the formulation, container, closure and manufacturing process did not inhibit...

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Publisher copy:
10.1016/j.ejps.2007.02.007

Authors


Sosabowski, JK More by this author
Dekker, BA More by this author
Simmons, BP More by this author
More by this author
Institution:
University of Oxford
Department:
Oxford, MSD, NDORMS
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Journal:
European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences
Volume:
31
Issue:
2
Pages:
102-111
Publication date:
2007-06-05
DOI:
EISSN:
1879-0720
ISSN:
0928-0987
URN:
uuid:b2bfda11-2d7b-4419-85f0-059ccc169621
Source identifiers:
504372
Local pid:
pubs:504372

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