OPKO Health has been granted a patent for a polypeptide combining chorionic gonadotropin and coagulation factor, along with related polynucleotides. The patent also covers pharmaceutical compositions and methods of use. The claim specifies a highly modified form of Factor VIIa with specific characteristics. GlobalData’s report on OPKO Health gives a 360-degree view of the company including its patenting strategy. Buy the report here.
According to GlobalData’s company profile on OPKO Health, Peptide pharmacophores was a key innovation area identified from patents. OPKO Health's grant share as of May 2024 was 47%. Grant share is based on the ratio of number of grants to total number of patents.
Human chorionic gonadotropin-modified factor viia polypeptide
A recently granted patent (Publication Number: US11976106B2) discloses a novel human chorionic gonadotropin carboxy terminal peptide (CTP)-modified human active Factor VII (FVIIa) polypeptide. This modified polypeptide consists of three CTP molecules attached in tandem to the C-terminal end of FVIIa, ensuring a substantially pure and active form. The CTP-modified FVIIa exhibits specific characteristics, including a high sialic acid content, high glycosylation form, low oxidized form, high percentage of carboxylated glutamic acid residues, charged N-glycans, and a potency of at least 10,500 U/mg. The amino acid sequence of this modified polypeptide is specified in SEQ ID NO: 7, with a purity level of at least 90%.
Furthermore, the patent claims detail the manufacturing process of the CTP-modified FVIIa, involving steps such as stably transfecting cells with an expression vector, obtaining overexpressing cell clones, expanding and harvesting these clones, filtering the solution, and purifying the CTP-modified FVIIa to achieve a desired concentration. The method ensures a high level of expression and secretion of the modified polypeptide, with a potency ranging from 15,563 U/mg to 23,608 U/mg. Notably, the manufacturing process is animal-free and results in a highly glycosylated, sialylated, and O-glycan content CTP-modified FVIIa, with specific glycosylation patterns and charged N-glycan percentages. The purification steps involve various chromatography columns and virus inactivation methods, ultimately yielding a purified CTP-modified FVIIa with a viral log reduction factor (LRF) of about 22. The patent also includes a composition comprising the CTP-modified FVIIa and a pharmaceutically acceptable carrier, highlighting the potential therapeutic applications of this novel polypeptide.
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