Liquid formulation comprising anti-human interferon alpha receptor 1 (ifnar1) monoclonal antibody

Abstract

The invention discloses a liquid preparation comprising anti-human interferon alpha receptor 1 (IFNAR1) monoclonal antibody, said liquid preparation comprising anti-human interferon alpha receptor 1 (IFNAR1) with a protein concentration of 100-200 mg / ml ) monoclonal antibody and basic amino acids at an amino acid concentration of 5‑300 mM; the anti-IFNAR1 monoclonal antibody comprises three heavy chain complementarity determining regions (CDR‑H1, CDR‑H2 and CDR‑H3) and three light chain complementary Determining regions (CDR‑L1, CDR‑L2 and CDR‑L3), wherein: (a) the amino acid sequence of CDR‑H1 is shown in SEQ ID NO: 1; (b) the amino acid sequence of CDR‑H2 is shown in SEQ ID NO: 2; (c) the amino acid sequence of CDR-H3 is shown in SEQ ID NO: 3; (d) the amino acid sequence of CDR-L1 is shown in SEQ ID NO: 4; (e) the amino acid sequence of CDR-L2 is shown in shown in SEQ ID NO: 5; and (f) the amino acid sequence of CDR‑L3 is shown in SEQ ID NO: 6. The liquid preparation has a low viscosity and can be easily injected by a syringe, so it can be used as an injection, especially a hypodermic injection.

Description

technical field [0001] The invention relates to the field of biotechnology, in particular to a liquid preparation containing anti-human interferon alpha receptor 1 (IFNAR1) monoclonal antibody. Background technique [0002] As a fast-growing market, the biologics market has numerous R&D pipelines and brings more innovative treatments to patients. For some diseases that are difficult to treat with traditional chemical drugs, biologics 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 forms of biological agents have gradually changed from freeze-dried dosage forms to aqueous injection dosage forms, and from intravenous administration to subcutaneous injection dosage forms. Since the dosage of monoclonal antibody injection is usually in the range of 100mg to 600mg, and the volume of subcutaneous injection is generally limited to less than 2ml, in such cases, highly ...

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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