Astellas Pharma. has been granted a patent for a stable pharmaceutical composition that includes a labeling moiety-anti-human antibody Fab fragment conjugate. The formulation features specific buffering agents, stabilizers, and a nonionic surfactant, maintaining a pH of 6.7 to prevent the formation of multimers and insoluble particles. GlobalData’s report on Astellas Pharma 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 Astellas Pharma, Cancer treatment biomarkers was a key innovation area identified from patents. Astellas Pharma's grant share as of July 2024 was 50%. Grant share is based on the ratio of number of grants to total number of patents.
The granted patent US12065503B2 describes a pharmaceutical composition that includes a labeling moiety-anti-human antibody Fab fragment conjugate, a buffering agent, a stabilizer, and a nonionic surfactant, all formulated to a pH of 6.7. The anti-human antibody Fab fragments are specifically derived from either CEACAM5 or MUC1 antibodies, with detailed amino acid sequences provided for both heavy and light chains. Notably, the heavy chain fragments may undergo modifications, such as the conversion of glutamic acid or glutamine into pyroglutamic acid. The composition may also incorporate a labeling moiety represented by a specific formula, and it can be presented in various forms, including liquid, frozen, or lyophilized formulations.
Additionally, the patent outlines methods for diagnosing colorectal and breast cancers using the described pharmaceutical composition, particularly emphasizing the detection of the conjugate containing the labeling moiety. The production method for the composition involves specific steps, including the addition of citric acid as a buffering agent, sucrose or glycerin as stabilizers, and Polysorbate 80 as a nonionic surfactant, with precise concentrations and pH adjustments. The patent further specifies the use of sucrose or glycerin as stabilizers at defined concentrations, ensuring the stability of the labeling moiety-anti-human antibody Fab fragment conjugate within the formulation.
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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
