Separation of recombinant erythropoietin and human serum albumin without the use of sophisticated equipment.

Autor: Zybin DI; PHARMAPARK LLC, 117246, Moscow, Russia. Electronic address: mithtchem@gmail.com., Klishin AA; PHARMAPARK LLC, 117246, Moscow, Russia., Orlova NV; PHARMAPARK LLC, 117246, Moscow, Russia., Zyryanov DА; PHARMAPARK LLC, 117246, Moscow, Russia., Prostyakova AI; M.M. Shemyakin and Yu.A. Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of Sciences, 117997, Moscow, Russia., Kapustin DV; M.M. Shemyakin and Yu.A. Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of Sciences, 117997, Moscow, Russia.
Jazyk: angličtina
Zdroj: Analytical biochemistry [Anal Biochem] 2025 Jan; Vol. 696, pp. 115673. Date of Electronic Publication: 2024 Sep 13.
DOI: 10.1016/j.ab.2024.115673
Abstrakt: A number of drugs based on recombinant erythropoietin contain human serum albumin as an auxiliary component. The presence of this protein hinders the proper control of the drug quality in accordance with the requirements of regulating agencies. We propose the novel method for separation of recombinant erythropoietin (epoetin beta) and human serum albumin. It is based on the subsequent use of hydrophobic sorbent and anion exchange resin placed in gravity flow columns (without the use of spin-columns). The proposed approach makes it possible to concentrate and purify the preparations containing the epoetin beta both at high and at minimal concentrations (the ratio of the amount of albumin and erythropoietin in the used preparations can reach 125:1). The average yield of epoetin beta after the use of hydrophobic sorbent and anion exchange resin was 75 % and 97 %, respectively. It was shown that the determined conditions of sample preparation had no affect on the content of the epoetin beta in the product.
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Zybin reports a relationship with Pharmapark LLC that includes: employment. Orlova reports a relationship with Pharmapark LLC that includes: employment. Klishin reports a relationship with Pharmapark LLC that includes: employment. Zyryanov reports a relationship with Pharmapark LLC that includes: employment. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2024 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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