Liquid formulation comprising anti-human thymic stromal lymphopoietin (tslp) monoclonal antibody

Abstract

This application discloses a liquid preparation of anti-human thymus stromal lymphopoietin (TSLP) monoclonal antibody, comprising anti-human thymus stromal lymphopoietin (TSLP) monoclonal antibody and amino acid protective agent, anti-human thymus stromal lymphocytes The protein concentration of the TSLP monoclonal antibody is 100-300mg / ml, and 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), wherein: The amino acid sequence of CDR‑H1 is shown in SEQ ID NO: 1; the amino acid sequence of CDR‑H2 is shown in SEQ ID NO: 2; the amino acid sequence of CDR‑H3 is shown in SEQ ID NO: 3; the amino acid of CDR‑L1 The sequence is shown in SEQ ID NO: 4; the amino acid sequence of CDR‑L2 is shown in SEQ ID NO: 5; the amino acid sequence of CDR‑L3 is shown in SEQ ID NO: 6. The liquid formulation of the present application has a low viscosity and can be easily injected with a syringe, so it can be used as an injection, especially a subcutaneous injection.

Description

technical field [0001] The present application relates to the field of biotechnology, and in particular, to a liquid preparation comprising an anti-human thymic stromal lymphopoietin (TSLP) monoclonal antibody. Background technique [0002] Therapeutic biological products, as a rapidly growing market, have 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, biologics targeted drugs provide more choices. On the other hand, in order to reduce the cost of clinical use of biological preparations and improve the compliance of patients, the dosage form of biological preparations has gradually changed from lyophilized to aqueous injection, and the route of administration has also changed from intravenous to subcutaneous injection. Since the dosage of monoclonal antibody injection is usually in the range of 100mg to 600mg, and the volume of s...

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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