Aggregate Forms of Recombinant Human Erythropoietin With Different Charge Profile Substantially Impact Biological Activities

Ghezlou, Mansoureh; Mokhtari, Farzad; Kalbasi, Alireza; Riazi, Gholamhossein; Kaghazian, Hooman; Emadi, Rahmatollah; Aref, Amir Reza

doi:10.1016/j.xphs.2019.05.036

Cited by 5 publications

(2 citation statements)

References 31 publications

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“…The I index, which takes into account the proportion of each isoform in the CE profile, calculated from the pattern obtained using the European Pharmacopoeia CE method, was used to this aim. The results showed that there was not a correlation between the I index and the biological activity and that other factors, mainly aggregation, affects the EPO biological activity [50].…”

Section: Therapeutic Drugsmentioning

confidence: 84%

“…When EPO is contained in biological samples (i.e., blood, urine, or cell cultures) the sample preparation is usually more complicated. For instance, when EPO is analyzed in CHO cell cultures [50] or from human urine samples [51] several purification steps involving affinity chromatography, size exclusion chromatography and ultra-filtration must be performed.…”

Section: Sample Preparationmentioning

confidence: 99%

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Biosimilars: development and investigation using achievements in modern biotechnology

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Biosimilars are biological drug products that have an equivalent clinical profile with innovator biotherapeutics but are developed under a reduced program. To this end, specific comparability approaches are followed based on reverse engineering that involves a thorough analysis of the innovator biotherapeutics and the development of the version of the latter, which should be as much as possible similar with respect to structural and functional characteristics with the innovator. This approach includes the evaluation and comparison between the biosimilar and innovator biologic with respect to the molecular structure and impurity profile and of biological activity in in vitro settings as well as pharmacokinetic, pharmacodynamic, and immunogenicity characteristics on human subjects. Where considered necessary, animal studies or phase 3 clinical studies might be performed when residual uncertainties remain in terms of biosimilarity, that could not have been resolved in the previous tests and trials. Any potentially inevitable differences should be insignificant for safety and efficacy. The state-of-the-art methods of biotechnology and analytics, when applied in line with the appropriate scientific and regulatory requirements, can allow developing similar biologics where no difference in the clinical profile exists with the respective innovator product. Available experience demonstrates the lack of major problems due to the incomparability between the biosimilar and corresponding reference biologics when applicable scientific standards and regulatory recommendations are met.

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Aggregate Forms of Recombinant Human Erythropoietin With Different Charge Profile Substantially Impact Biological Activities

Cited by 5 publications

References 31 publications

Capillary electrophoresis of glycoproteins

Capillary electrophoresis of glycoproteins

Advances and applications of capillary electromigration methods in the analysis of therapeutic and diagnostic recombinant proteins – A Review

Biosimilars: development and investigation using achievements in modern biotechnology

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