Establishment and standardization of a technology for the production of ready-to-use cold kit formulations for labelling DOTA-Rituximab and peptide-based conjugates with Lu-177 and Y-90

Janevik-Ivanovska, Emilija (2012) Establishment and standardization of a technology for the production of ready-to-use cold kit formulations for labelling DOTA-Rituximab and peptide-based conjugates with Lu-177 and Y-90. [Project]

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Abstract

The purpose of this investigation was to introduce a technology for ready to use production of cold kit formulation of DOTA-Rituximab and peptide based radiopharmaceuticals (Substance P) for labeling with lu-177 and Y-90, to establish and to standardize the methods for synthesis and conjugation. In the same time using a model system comprised in both isolated cell cultures and animal model the radiolabeled yield, biological properties and pharmacokinetic behavior of 177Lu-DOTA Rituximab and Supstance P to compare and to determine toxicities and therapeutic efficacies. The work for Substance P has the goal to obtain the peptide available for the labeling with lu-177 was necessary to start from the model already used for labeling with Tc-99m and Re-188. For this purpose we synthesized Substance P modified for Tc-99m and Re-188 labeling and examine the characteristics including biodistribution studies in normal mice (Peptide No.1 - Cys-Cys-SP /PCN for Tc-99m labeling and Peptide No.2 - Cys-Cys-SP /PCN for Re-188 labeling). The other part of our work is to establish the procedure of freeze drying to obtain the final kit formulation for the antibody, ready for labeling. The procedure of freeze drying should provide stable formulation identically available for preclinical investigation as the freshly prepared solution. The freeze dried formulation should have the same immunoreactivity of the conjugated antibody before conjugation and after conjugation in the liquid formulation. For this reason the most important steps in which we were working in our first part of the project was to establish the protocol and to estimat the Freeze-Drying Time for Lyophilized Formulations of Monoclonal Antibody in each phase – Prefreezing, Primary Drying and Secondary Drying.

Item Type: Project
Subjects: Medical and Health Sciences > Health sciences
Divisions: Faculty of Medical Science
Depositing User: Emilija Janevik
Date Deposited: 01 Feb 2013 10:06
Last Modified: 01 Feb 2013 10:06
URI: http://eprints.ugd.edu.mk/id/eprint/5305

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