Glenmark Pharmaceuticals has been granted a patent for a method to prepare viral-contaminant-free antibody solutions from cultured cells. The process involves treating the antibody material with high pH and filtration to remove impurities. The high target pH ranges from 10.2 to 11.0. GlobalData’s report on Glenmark Pharmaceuticals 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 Glenmark Pharmaceuticals, Nanoparticle drug conjugates was a key innovation area identified from patents. Glenmark Pharmaceuticals's grant share as of January 2024 was 28%. Grant share is based on the ratio of number of grants to total number of patents.

Method for purifying antibodies from cell cultures

Source: United States Patent and Trademark Office (USPTO). Credit: Glenmark Pharmaceuticals Ltd

A recently granted patent (Publication Number: US11884700B2) discloses a method for the removal of impurities from a clarified harvest antibody material. The method involves culturing host cells expressing an antibody, harvesting the antibody material, subjecting it to a clarification step, treating the resulting material with high pH to achieve a target pH between 10.2 to 11.0, and then filtering to remove impurities such as host cell proteins, nucleic acids, and cell debris. The high target pH can be specifically set at 10.8 or 11, and achieved using buffers like Tris, Histidine L-Arginine, phosphate, or NaOH.

Furthermore, the patent details a method that includes subjecting the clarified harvest antibody material to protein A chromatography, treating the resulting protein A eluate with high pH to reach a target pH between 10.2 to 11.0, and then filtering to remove impurities. The process may involve incubating the eluate with NaOH 0.5M to reach a target pH of about 11, holding it at this pH for at least 60 minutes at room temperature, and subsequently neutralizing the eluate. Variations in the target pH, incubation conditions, and neutralization steps are also described in the patent, providing flexibility in the purification process for antibody materials.

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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