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

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...

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Autores principales: Sinegubova, Maria, Vorobiev, Ivan, Klishin, Anatoly, Eremin, Dmitry, Orlova, Nadezhda, Orlova, Natalya, Polzikov, Mikhail
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8781808/
https://www.ncbi.nlm.nih.gov/pubmed/35056992
http://dx.doi.org/10.3390/pharmaceutics14010096
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author Sinegubova, Maria
Vorobiev, Ivan
Klishin, Anatoly
Eremin, Dmitry
Orlova, Nadezhda
Orlova, Natalya
Polzikov, Mikhail
author_facet Sinegubova, Maria
Vorobiev, Ivan
Klishin, Anatoly
Eremin, Dmitry
Orlova, Nadezhda
Orlova, Natalya
Polzikov, Mikhail
author_sort Sinegubova, Maria
collection PubMed
description 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.
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spelling pubmed-87818082022-01-22 Purification Process of a Recombinant Human Follicle Stimulating Hormone Biosimilar (Primapur(®)) to Yield a Pharmaceutical Product with High Batch-to-Batch Consistency Sinegubova, Maria Vorobiev, Ivan Klishin, Anatoly Eremin, Dmitry Orlova, Nadezhda Orlova, Natalya Polzikov, Mikhail Pharmaceutics Article 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. MDPI 2022-01-01 /pmc/articles/PMC8781808/ /pubmed/35056992 http://dx.doi.org/10.3390/pharmaceutics14010096 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Sinegubova, Maria
Vorobiev, Ivan
Klishin, Anatoly
Eremin, Dmitry
Orlova, Nadezhda
Orlova, Natalya
Polzikov, Mikhail
Purification Process of a Recombinant Human Follicle Stimulating Hormone Biosimilar (Primapur(®)) to Yield a Pharmaceutical Product with High Batch-to-Batch Consistency
title Purification Process of a Recombinant Human Follicle Stimulating Hormone Biosimilar (Primapur(®)) to Yield a Pharmaceutical Product with High Batch-to-Batch Consistency
title_full Purification Process of a Recombinant Human Follicle Stimulating Hormone Biosimilar (Primapur(®)) to Yield a Pharmaceutical Product with High Batch-to-Batch Consistency
title_fullStr Purification Process of a Recombinant Human Follicle Stimulating Hormone Biosimilar (Primapur(®)) to Yield a Pharmaceutical Product with High Batch-to-Batch Consistency
title_full_unstemmed Purification Process of a Recombinant Human Follicle Stimulating Hormone Biosimilar (Primapur(®)) to Yield a Pharmaceutical Product with High Batch-to-Batch Consistency
title_short Purification Process of a Recombinant Human Follicle Stimulating Hormone Biosimilar (Primapur(®)) to Yield a Pharmaceutical Product with High Batch-to-Batch Consistency
title_sort purification process of a recombinant human follicle stimulating hormone biosimilar (primapur(®)) to yield a pharmaceutical product with high batch-to-batch consistency
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8781808/
https://www.ncbi.nlm.nih.gov/pubmed/35056992
http://dx.doi.org/10.3390/pharmaceutics14010096
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