Fresenius SE & Co has patented a method using hydroxyapatite resin to purify adalimumab or biosimilars by binding impurities, resulting in a pharmaceutical composition with reduced impurities. The method involves specific conditions for binding, washing, and eluting the antibody. GlobalData’s report on Fresenius SE & Co gives a 360-degree view of the company including its patenting strategy. Buy the report here.

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According to GlobalData’s company profile on Fresenius SE & Co, was a key innovation area identified from patents. Fresenius SE & Co's grant share as of February 2024 was 59%. Grant share is based on the ratio of number of grants to total number of patents.

Purifying adalimumab using hydroxyapatite resin

Source: United States Patent and Trademark Office (USPTO). Credit: Fresenius SE & Co KGaA

A recently granted patent (Publication Number: US11919924B1) discloses a method for purifying antibodies with specific light and heavy chain sequences from a sample containing the antibody and impurities. The method involves contacting the sample with a hydroxyapatite resin, washing the resin to separate impurities, and eluting the purified antibody. The conditions for binding and elution are detailed, ensuring a lower level of impurities in the final eluate compared to the initial sample. The patent also covers the purification of adalimumab or its biosimilars, targeting impurities such as host cell proteins, nucleic acids, lipids, and aggregates of the antibody or its fragments.

Furthermore, the patent extends to a method for producing antibodies with the specified chain sequences by expressing them in CHO cells, followed by purification using the hydroxyapatite resin. The process involves binding the antibody to the resin, washing to remove impurities, and eluting the purified antibody. The elution buffer composition and conditions are crucial in achieving a high purity level in the final eluate. The patent emphasizes the reduction of aggregates and fragments in the eluate compared to the initial sample, ensuring a high-quality purified antibody product. Overall, the patented methods offer a precise and efficient way to purify antibodies with specific chain sequences, particularly targeting impurities and ensuring a high level of purity in the final product.

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData Patent Analytics tracks bibliographic data, legal events data, point in time patent ownerships, and backward and forward citations from global patenting offices. Textual analysis and official patent classifications are used to group patents into key thematic areas and link them to specific companies across the world’s largest industries.