Liquid preparation comprising anti-human thymic stromal lymphopoietin (TSLP) monoclonal antibody

Abstract

The invention discloses a liquid preparation of an anti-human thymic stromal lymphopoietin (TSLP) monoclonal antibody. The liquid preparation comprises an anti-human thymic stromal lymphopoietin (TSLP) monoclonal antibody and an amino acid protection agent, wherein the protein concentration of the anti-human thymic stromal lymphopoietin (TSLP) monoclonal antibody is 100-300mg / ml, the amino acid concentration of the amino acid protection agent is 10-500mM, the monoclonal antibody comprises three heavy chain complementarity determining regions (CDR-H1, CDR-H2 and CDR-H3) and three light chain complementarity determining regions (CDR-L1, CDR-L2 and CDR-L3), the amino acid sequence of the CDR-H1 is as shown in SEQ ID NO: 1, the amino acid sequence of the CDR-H2 is as shown in SEQ ID NO: 2, the amino acid sequence of the CDR-H3 is as shown in SEQ ID NO: 3, the amino acid sequence of the CDR-L1 is as shown in SEQ ID NO: 4, the amino acid sequence of the CDR-L2 is as shown in SEQ ID NO: 5, and the amino acid sequence of the CDR-L3 is as shown in SEQ ID NO: 6. The liquid preparation disclosed by the invention is relatively low in viscosity and can be easily injected by a syringe, so that the liquid preparation can be used as an injection, especially a hypodermic injection.

Description

technical field [0001] The present application relates to the field of biotechnology, in particular to a liquid preparation containing anti-human thymus stromal lymphopoietin (TSLP) monoclonal antibody. Background technique [0002] Therapeutic biological products are a fast-growing market with numerous R&D pipelines, and at the same time bring more innovative therapies to patients. For some autoimmune-related diseases that are difficult to treat with traditional small molecule drugs, biological drug targeted drugs provide more choices. On the other hand, in order to reduce the cost of clinical use of biological agents and improve patient compliance, the dosage form of biological agents has gradually changed from freeze-dried dosage form to aqueous injection dosage form, and the route of administration has also changed from intravenous administration to subcutaneous injection dosage form. Since the dosage of monoclonal antibody injection is usually in the range of 100mg to ...

AI Technical Summary

Problems solved by technology

In some extreme cases, a gel-like substance may even form, which brings great challenges to the ultrafiltration membrane and the ultrafiltration equipment itself, such as the decrease in the tangential flow rate caused by the rapid increase in the pressure difference during the final concentration, and the concentration difference Polarization gets out of control until protein precipitation clogs the membrane, which inevitably leads to reduced recovery or process failure

On the other hand, even if the final high-concentration protein solution is obtained by improving the equipment or membrane type, it is difficult to put it into actual clinical application, because it needs to be sucked by disposable sterile syringe or prefilled needle for subcutaneous administration The final packaging form, and too high viscosity will reduce the sliding performance of the filled syringe, so that it cannot be manually pushed into the subcutaneous

Another difficulty in concentrating high-concentration monoclonal antibody solutions by ultrafiltration is that protein samples tend to aggregate to form soluble aggregates when highly concentrated, and further aggregate to form protein precipitates

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