Celltrion. has been granted a patent for a stable liquid formulation containing an antibody, acetate buffer, glycine, and a surfactant. This formulation, free from sugars and metal salts, maintains stability at high antibody concentrations and is suitable for subcutaneous administration, with specific osmolality and viscosity parameters. GlobalData’s report on Celltrion gives a 360-degree view of the company including its patenting strategy. Buy the report here.
According to GlobalData’s company profile on Celltrion, Peptide nano-particle conjugates was a key innovation area identified from patents. Celltrion's grant share as of June 2024 was 29%. Grant share is based on the ratio of number of grants to total number of patents.
The granted patent US11986523B2 outlines a novel liquid formulation designed for the administration of antibodies or antigen-binding portions. The formulation includes an antibody concentration ranging from 50 to 150 mg/mL, an acetate buffer with an acetate concentration of 1 to 30 mM, glycine at 210 to 300 mM, and a surfactant concentration of 0.01 to 1% (w/v). Notably, the formulation is characterized by its osmolality, which falls between 200 to 400 mmol/kg, and it explicitly excludes certain excipients such as sucrose, trehalose, mannitol, sorbitol, and NaCl. The pH of the formulation is maintained between 4.5 and 5.5, and it does not contain preservatives or chelating agents.
Further claims detail the specific amino acid sequences of the light-chain and heavy-chain variable regions of the antibody, as well as the types of surfactants that may be used, including various Polysorbate compounds. The formulation is intended for subcutaneous administration and can be packaged in pre-filled syringes or auto-injectors, enhancing its usability for therapeutic applications. This patent presents a comprehensive approach to antibody formulation, focusing on stability and compatibility for effective delivery.
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