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Article

Purification Process of a Recombinant Human Follicle Stimulating Hormone Biosimilar (Primapur®) to Yield a Pharmaceutical Product with High Batch-to-Batch Consistency

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Laboratory of Mammalian Cell Bioengineering, Institute of Bioengineering, Federal State Institution «Federal Research Centre «Fundamentals of Biotechnology» of the Russian Academy of Sciences», Leninsky Prospect, 33, Build. 2, 119071 Moscow, Russia
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IVFarma LLC, Nauchnyi Proezd, 20, Build. 2, 117246 Moscow, Russia
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State Research Institute of Genetics and Selection of Industrial Microorganisms of National Research Center «Kurchatov Institute», Dorozhniy Proezd, 1, 117545 Moscow, Russia
*
Authors to whom correspondence should be addressed.
Academic Editors: Alessandro Parodi and Dmitry Kostyushev
Pharmaceutics 2022, 14(1), 96; https://doi.org/10.3390/pharmaceutics14010096
Received: 29 November 2021 / Revised: 24 December 2021 / Accepted: 28 December 2021 / Published: 1 January 2022
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. View Full-Text
Keywords: biopharmaceuticals; biosimilars; recombinant human follicle stimulating hormone (r-hFSH); follitropin alpha; downstream; immunoaffinity chromatography; dynamic binding capacity (DBC); batch-to-batch consistency biopharmaceuticals; biosimilars; recombinant human follicle stimulating hormone (r-hFSH); follitropin alpha; downstream; immunoaffinity chromatography; dynamic binding capacity (DBC); batch-to-batch consistency
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MDPI and ACS Style

Sinegubova, M.; Vorobiev, I.; Klishin, A.; Eremin, D.; Orlova, N.; Orlova, N.; Polzikov, M. Purification Process of a Recombinant Human Follicle Stimulating Hormone Biosimilar (Primapur®) to Yield a Pharmaceutical Product with High Batch-to-Batch Consistency. Pharmaceutics 2022, 14, 96. https://doi.org/10.3390/pharmaceutics14010096

AMA Style

Sinegubova M, Vorobiev I, Klishin A, Eremin D, Orlova N, Orlova N, Polzikov M. Purification Process of a Recombinant Human Follicle Stimulating Hormone Biosimilar (Primapur®) to Yield a Pharmaceutical Product with High Batch-to-Batch Consistency. Pharmaceutics. 2022; 14(1):96. https://doi.org/10.3390/pharmaceutics14010096

Chicago/Turabian Style

Sinegubova, Maria, Ivan Vorobiev, Anatoly Klishin, Dmitry Eremin, Nadezhda Orlova, Natalya Orlova, and Mikhail Polzikov. 2022. "Purification Process of a Recombinant Human Follicle Stimulating Hormone Biosimilar (Primapur®) to Yield a Pharmaceutical Product with High Batch-to-Batch Consistency" Pharmaceutics 14, no. 1: 96. https://doi.org/10.3390/pharmaceutics14010096

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