Celltrion has been granted a patent for a stable liquid formulation for subcutaneous administration of antibodies. The formulation includes specific ingredients like acetate buffer, glycine, and a surfactant, without sugars or metal salts. The formulation allows for high antibody content while maintaining stability. 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 May 2024 was 26%. Grant share is based on the ratio of number of grants to total number of patents.
A recently granted patent (Publication Number: US11986523B2) discloses a liquid formulation designed for the stable delivery of antibodies or antigen-binding portions. The formulation includes an antibody with a concentration of 50 to 150 mg/mL, glycine at a concentration of 210 to 300 mM, and an acetate buffer with an acetate concentration of 1 to 30 mM. The formulation also contains a surfactant and has an osmolality ranging from 200 to 400 mmol/kg. Notably, the formulation excludes common additives such as sucrose, trehalose, mannitol, sorbitol, and NaCl, ensuring a specific composition for optimal stability and efficacy.
Furthermore, the patent details specific characteristics of the antibody used in the formulation, including the amino acid sequences of the CDR domains in both the light-chain and heavy-chain variable regions. The surfactant in the formulation, which can be polysorbate, poloxamer, or a mixture thereof, is present at a concentration of 0.01 to 1% (w/v). The pH of the liquid formulation ranges from 4.5 to 5.5, and it does not contain preservatives or chelating agents. Additionally, the patent covers the use of this formulation for subcutaneous administration, as well as its application in pre-filled syringes and auto-injectors, highlighting its potential for convenient and effective delivery of therapeutic antibodies.
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