Translation of experience and knowledge for formulation of conjugation of conjugated monoclonal antibodies for labeling

Apostolova, Paulina and Arev, Marija and Janevik-Ivanovska, Emilija (2023) Translation of experience and knowledge for formulation of conjugation of conjugated monoclonal antibodies for labeling. In: 8th Congress of Pharmacy with International Participation, 27-30 April, 2023, Hotel Rila, Borovets, Bulgaria.

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Abstract

(I.) The aim of the study
The purpose of this study is to utilize previous research on the formulation of conjugated antibodies as radiopharmaceuticals utilizing beta emitters, and to apply this knowledge to the development of immunoconjugates suitable for labeling with alpha emitters.
(II.) Materials and methods
Monoclonal antibodies were chosen as the primary molecules for labeling due to their well-established pharmacokinetic and pharmacodynamic characteristics, as well as their targeted receptors for specific diseases. The process of formulating Rituximab or Trastuzumab immunoconjugate complexes involved purifying the antibodies, preparing concentrated antibody solutions, conjugating with chelators, and, if necessary, lyophilization.
(III.) Results
After the formulation of the immunoconjugates and labeling with radioisotope, our experience showed that the following parameters are crucial to be observed:
- the stability of used ligands and obtained radiolabeled complex;
- appropriate validated analytical methods used for quality control of radiolabeled immunoconjugates;
- in vivo stability and pharmacokinetics of radiolabeled immunoconjugates;
- in vitro determination of degradation products of radiolabeled immunoconjugates;
- in vitro cell studies for determination of immunoreactivity and binding radiolabeled immunoconjugates.
(IV.) Conclusion
Overall, while significant theoretical and experimental research has been conducted in this field, the labeling of monoclonal antibodies remains a challenging task. Future studies should primarily focus on obtaining formulations with high chemical and radiochemical stability through standardized labeling procedures. Based on our previous research, in vivo studies of biodistribution, pharmacokinetics, toxicity, dose prediction because of preclinical in vitro cell culture studies should be critical indicators for translation to the clinical trials.

Item Type:	Conference or Workshop Item (Poster)
Subjects:	Medical and Health Sciences > Basic medicine
Divisions:	Faculty of Medical Science
Depositing User:	Marija Arev
Date Deposited:	18 May 2023 10:21
Last Modified:	18 May 2023 10:21
URI:	https://eprints.ugd.edu.mk/id/eprint/31769

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