Celltrion. has filed a patent for a stable pharmaceutical formulation that contains an antibody or antigen-binding fragment that binds to an interleukin-6 receptor. The formulation has a low viscosity, even at high concentrations, and demonstrates excellent long-term storage stability. It can be administered intravenously or subcutaneously. GlobalData’s report on Celltrion 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 Celltrion, Peptide nano-particle conjugates was a key innovation area identified from patents. Celltrion's grant share as of September 2023 was 22%. Grant share is based on the ratio of number of grants to total number of patents.

Stable pharmaceutical formulation for interleukin-6 receptor antibody

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

A recently filed patent (Publication Number: US20230312734A1) describes a stable pharmaceutical formulation for the treatment of diseases associated with the interleukin-6 receptor. The formulation includes an antibody or antigen-binding fragment that binds to the receptor, a surfactant, a stabilizer, and a buffer.

The stable pharmaceutical formulation consists of an antibody or antigen-binding fragment that specifically binds to the interleukin-6 receptor, which is involved in various diseases. The formulation also includes a surfactant, which helps to improve the stability of the formulation. Additionally, a stabilizer is included in the formulation, which can be an amino acid or amino acid derivative, or a sugar, sugar alcohol, or a mixture thereof. The stabilizer helps to maintain the integrity and activity of the antibody or antigen-binding fragment. Finally, a buffer is included in the formulation to maintain the desired pH.

The antibody or antigen-binding fragment in the formulation can have specific amino acid sequences, as described in the patent. One example is tocilizumab, which is a known antibody that binds to the interleukin-6 receptor. The pharmaceutical formulation can be in liquid form and can have a concentration of the antibody or antigen-binding fragment ranging from 1 mg/ml to 300 mg/ml.

The stabilizer in the formulation can be selected from various amino acids or amino acid derivatives, such as threonine, methionine, arginine, proline, leucine, glycine, taurine, or a mixture thereof. In one embodiment, the stabilizer can be a mixture of threonine and methionine, with specific concentration ranges.

The buffer in the formulation can include various compounds, such as histidine or its salts, acetic acid or its salts, phosphoric acid or its salts, citric acid or its salts, succinic acid or its salts, or a mixture thereof. The stable pharmaceutical formulation can have specific concentrations of the antibody or antigen-binding fragment, surfactant, stabilizer, and buffer.

The patent also describes the use of the stable pharmaceutical formulation for treating diseases associated with the interleukin-6 receptor. The formulation can be administered to a subject in need of treatment, either intravenously or subcutaneously. The formulation can be configured for dilution prior to intravenous administration and can be contained within a container. Overall, the patent provides a detailed description of a stable pharmaceutical formulation and its use for the treatment of diseases associated with the interleukin-6 receptor.

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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