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

Pharmaceutics

Mikhail Polzikov¹  Dmitry Eremin¹  Maria Sinegubova²  Nadezhda Orlova²  Ivan Vorobiev²  Natalya Orlova³  Anatoly Klishin³ 

[1] IVFarma LLC, Nauchnyi Proezd, 20, Build. 2, 117246 Moscow, Russia;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;State Research Institute of Genetics and Selection of Industrial Microorganisms of National Research Center «Kurchatov Institute», Dorozhniy Proezd, 1, 117545 Moscow, Russia;

关键词: biopharmaceuticals;    biosimilars;    recombinant human follicle stimulating hormone (r-hFSH);    follitropin alpha;    downstream;    immunoaffinity chromatography;   

DOI  :  10.3390/pharmaceutics14010096

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown