Amgen has been granted a patent for anti-PCSK9 antibody crystals. The patent describes methods of making these crystals and formulations containing them. The crystals are made by combining a solution of the antibody with a crystallization reagent, which includes various salts at a pH of about 6 to about 8. GlobalData’s report on Amgen 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 Amgen, NSAID cancer drugs was a key innovation area identified from patents. Amgen's grant share as of September 2023 was 42%. Grant share is based on the ratio of number of grants to total number of patents.

Crystal formation of anti-pcsk9 antibody using specific reagents

Source: United States Patent and Trademark Office (USPTO). Credit: Amgen Inc

A recently granted patent (Publication Number: US11773184B2) describes a method for producing crystals of an anti-PCSK9 IgG antibody. The method involves combining a solution of the antibody with a crystallization reagent. The antibody used in the method contains specific sequences for both the light chain and heavy chain complementarity determining regions.

The crystallization reagent used in the method includes various salts such as sodium dihydrogen phosphate, di-potassium hydrogen phosphate, sodium chloride, ammonium sulfate, and others. The reagent is maintained at a pH level between 6 and 8. The concentration of salt in the reagent ranges from 0.1M to 10M.

Additionally, the crystallization reagent may also contain polyethylene glycol (PEG) with a molecular weight between 1,000 kDa and 5,000 kDa. The concentration of PEG in the reagent is between 10% and 50%. The presence of PEG aids in the formation of crystals.

After the crystals have formed, a portion of the crystallization reagent can be removed through centrifugation. The crystals can then be placed in a solution containing an organic additive, such as ethanol or isopropanol. An excipient, such as sucrose, trehalose, or sorbitol, may also be added to the solution.

The crystals can be dried through exposure to air, vacuum, or nitrogen gas. In one specific embodiment, the crystallization reagent includes sodium acetate trihydrate at a pH level between 6 and 8, along with PEG at a concentration of 11% to 13%.

The patent also describes alternative sequences for the light and heavy chains of the anti-PCSK9 IgG antibody. These alternative sequences can be used in the method to produce crystals.

In summary, the granted patent outlines a method for producing crystals of an anti-PCSK9 IgG antibody. The method involves combining the antibody solution with a specific crystallization reagent containing salts and PEG. The crystals can be further processed by removing the reagent, adding organic additives and excipients, and drying them. The patent also provides alternative sequences for the antibody's light and heavy chains.

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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