Introduction to Biological and Small Molecule Drug Research and Development: Chapter 10. Recombinant human erythropoietin and its analogues

Introduction to Biological and Small Molecule Drug Research and Development: Chapter 10. Recombinant human erythropoietin and its analogues
ISBN-10
0128062002
ISBN-13
9780128062005
Series
Introduction to Biological and Small Molecule Drug Research and Development
Category
Science
Pages
472
Language
English
Published
2013-05-07
Publisher
Elsevier Inc. Chapters
Author
Wolfgang Jelkmann

Description

The renal hormone erythropoietin (Epo) is essential for the viability and proliferation of the erythrocytic progenitors generating reticulocytes in the bone marrow. Human Epo consists of a chain of 165 amino acid residues and four glycans. The synthesis of Epo is strongly stimulated by hypoxia. Epo deficiency is the primary cause of the anaemia in chronic kidney disease (CKD). For anaemia treatment recombinant human Epo (rhEpo/epoetin and epoetin) is very useful. The drug substance is generally manufactured in EPO complementary DNA (cDNA) transfected Chinese hamster ovary cell cultures. rhEpo therapy is beneficial not only for CKD patients but also for anaemic cancer patients receiving chemotherapy. The expiry of the patents for the first original rhEpo formulations has initiated the production of similar biological medicinal products (‘biosimilars’). The term ‘biosimilar’ should only be used for a medicinal product approved on a strict regulatory pathway (i.e. European Medicines Agency, Food and Drug Administration, etc.). Unfortunately, many claimed ‘biosimilars’ have not been through an approval authority. Furthermore, rhEpo analogues with prolonged survival in circulation (‘biobetter’) have been developed and synthetic Epo mimetic peptides have been developed for therapy. The biological role of Epo outside the bone marrow is the focus of current research.

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