Open Access
Pharmaceutics, volume 14, issue 1, pages 96
Purification Process of a Recombinant Human Follicle Stimulating Hormone Biosimilar (Primapur®) to Yield a Pharmaceutical Product with High Batch-to-Batch Consistency
Sinegubova Maria V
1, 2
,
Vorobiev Ivan I
1
,
Klishin Anatoly
3
,
Eremin Dmitry
2
,
Orlova E A
1
,
Orlova Natalya
3
,
Polzikov Mikhail A.
2
2
IVFarma LLC, Nauchnyi Proezd, 20, Build. 2, 117246 Moscow, Russia
|
Publication type: Journal Article
Publication date: 2022-01-01
PubMed ID:
35056992
Pharmaceutical Science
Abstract
Recombinant human follicle stimulating hormone (r-hFSH) is widely used for infertility treatment and is subject to the development of biosimilars. There are different purification strategies that can yield r-hFSH of pharmaceutical quality from Chinese hamster ovary cell culture broth. We developed a purification process for r-hFSH centered on immunoaffinity chromatography with single-domain recombinant camelid antibodies. The resulting downstream process is simple and devoid of ultrafiltration operations. Studies on chromatography resin resource and ligand leakage showed that the immunoaffinity matrix employed was suitable for industrial use and stable for at least 40 full chromatography cycles, and the leaked single-domain antibody ligand was completely removed by subsequent purification steps. All chromatography resins employed withstood the same 40 cycles of use without significant changes in separation efficiency and product binding capacity. The resulting industrial purification process yielded batches of r-hFSH with consistent levels of purity and bioactivity.
Citations by journals
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1
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International Journal of Molecular Sciences
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International Journal of Molecular Sciences
1 publication, 33.33%
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FARMAKOEKONOMIKA Modern Pharmacoeconomics and Pharmacoepidemiology
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FARMAKOEKONOMIKA Modern Pharmacoeconomics and Pharmacoepidemiology, 1, 33.33%
FARMAKOEKONOMIKA Modern Pharmacoeconomics and Pharmacoepidemiology
1 publication, 33.33%
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Chemical Engineering Journal
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Chemical Engineering Journal
1 publication, 33.33%
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1
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Citations by publishers
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1
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Multidisciplinary Digital Publishing Institute (MDPI)
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Multidisciplinary Digital Publishing Institute (MDPI)
1 publication, 33.33%
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IRBIS
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IRBIS, 1, 33.33%
IRBIS
1 publication, 33.33%
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Elsevier
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Elsevier
1 publication, 33.33%
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1
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Sinegubova M. V. et al. Purification Process of a Recombinant Human Follicle Stimulating Hormone Biosimilar (Primapur®) to Yield a Pharmaceutical Product with High Batch-to-Batch Consistency // Pharmaceutics. 2022. Vol. 14. No. 1. p. 96.
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Sinegubova M. V., Vorobiev I. I., Klishin A., Eremin D., Orlova E. A., Orlova N., Polzikov M. A. Purification Process of a Recombinant Human Follicle Stimulating Hormone Biosimilar (Primapur®) to Yield a Pharmaceutical Product with High Batch-to-Batch Consistency // Pharmaceutics. 2022. Vol. 14. No. 1. p. 96.
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TY - JOUR
DO - 10.3390/pharmaceutics14010096
UR - https://doi.org/10.3390%2Fpharmaceutics14010096
TI - Purification Process of a Recombinant Human Follicle Stimulating Hormone Biosimilar (Primapur®) to Yield a Pharmaceutical Product with High Batch-to-Batch Consistency
T2 - Pharmaceutics
AU - Klishin, Anatoly
AU - Eremin, Dmitry
AU - Orlova, Natalya
AU - Sinegubova, Maria V
AU - Vorobiev, Ivan I
AU - Orlova, E A
AU - Polzikov, Mikhail A.
PY - 2022
DA - 2022/01/01 00:00:00
PB - Multidisciplinary Digital Publishing Institute (MDPI)
SP - 96
IS - 1
VL - 14
PMID - 35056992
SN - 1999-4923
ER -
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@article{2022_Sinegubova,
author = {Anatoly Klishin and Dmitry Eremin and Natalya Orlova and Maria V Sinegubova and Ivan I Vorobiev and E A Orlova and Mikhail A. Polzikov},
title = {Purification Process of a Recombinant Human Follicle Stimulating Hormone Biosimilar (Primapur®) to Yield a Pharmaceutical Product with High Batch-to-Batch Consistency},
journal = {Pharmaceutics},
year = {2022},
volume = {14},
publisher = {Multidisciplinary Digital Publishing Institute (MDPI)},
month = {jan},
url = {https://doi.org/10.3390%2Fpharmaceutics14010096},
number = {1},
pages = {96},
doi = {10.3390/pharmaceutics14010096}
}
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MLA
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Sinegubova, Maria V., et al. “Purification Process of a Recombinant Human Follicle Stimulating Hormone Biosimilar (Primapur®) to Yield a Pharmaceutical Product with High Batch-to-Batch Consistency.” Pharmaceutics, vol. 14, no. 1, Jan. 2022, p. 96. https://doi.org/10.3390%2Fpharmaceutics14010096.