피하 투여를 위한 항-CD38 항체의 제형

항-CD38 항체의 제형을 필요로 하는 대상체에게 피하 투여하기에 적합한 항-CD38 항체의 제형이 제공된다. 본 제형은 고농도의 항체, 점도 감소제, 안정화제, 완충제 및 계면활성제를 포함한다. 특정 실시 형태에서, 용액의 점도는 최대 25 mPa·s이고, 용액의 pH는 5.9 내지 7.0이다. 특정 실시 형태에서, 항-CD38 항체는 이사툭시맙(Isatuximab)이다. 제형은 인간에서 다발성 골수종을 비롯한 CD38+ 혈액 악성종양, 및 자가면역 및 염증성 질환을 치료하는 데 사용될 것이다. Provided are formul...

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Hauptverfasser: BANGARI KIRAN, FILIPE VASCO, CHARI RAVI, HUILLE SYLVAIN, PEREZ RAMIREZ BERNARDO, BALLET THOMAS
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creator BANGARI KIRAN
FILIPE VASCO
CHARI RAVI
HUILLE SYLVAIN
PEREZ RAMIREZ BERNARDO
BALLET THOMAS
description 항-CD38 항체의 제형을 필요로 하는 대상체에게 피하 투여하기에 적합한 항-CD38 항체의 제형이 제공된다. 본 제형은 고농도의 항체, 점도 감소제, 안정화제, 완충제 및 계면활성제를 포함한다. 특정 실시 형태에서, 용액의 점도는 최대 25 mPa·s이고, 용액의 pH는 5.9 내지 7.0이다. 특정 실시 형태에서, 항-CD38 항체는 이사툭시맙(Isatuximab)이다. 제형은 인간에서 다발성 골수종을 비롯한 CD38+ 혈액 악성종양, 및 자가면역 및 염증성 질환을 치료하는 데 사용될 것이다. Provided are formulations of anti-CD38 antibodies suitable for subcutaneous administration to a subject in need thereof. The formulations include a high concentration of antibody, a viscosity lowering agent, a stabilizing agent, a buffering agent and a surfactant. In certain embodiments, the viscosity of the solution is at most 25 mPa·s, and the pH of the solution is 5.9 to 7.0. In certain embodiments, the anti-CD38 antibody is isatuximab. The formulations will find use in treating CD38+ hematological malignancies, including multiple myeloma, as well as autoimmune and inflammatory diseases, in humans.
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Provided are formulations of anti-CD38 antibodies suitable for subcutaneous administration to a subject in need thereof. The formulations include a high concentration of antibody, a viscosity lowering agent, a stabilizing agent, a buffering agent and a surfactant. In certain embodiments, the viscosity of the solution is at most 25 mPa·s, and the pH of the solution is 5.9 to 7.0. In certain embodiments, the anti-CD38 antibody is isatuximab. 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Provided are formulations of anti-CD38 antibodies suitable for subcutaneous administration to a subject in need thereof. The formulations include a high concentration of antibody, a viscosity lowering agent, a stabilizing agent, a buffering agent and a surfactant. In certain embodiments, the viscosity of the solution is at most 25 mPa·s, and the pH of the solution is 5.9 to 7.0. In certain embodiments, the anti-CD38 antibody is isatuximab. The formulations will find use in treating CD38+ hematological malignancies, including multiple myeloma, as well as autoimmune and inflammatory diseases, in humans.</abstract><oa>free_for_read</oa></addata></record>
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subjects CHEMISTRY
HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
METALLURGY
ORGANIC CHEMISTRY
PEPTIDES
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS
title 피하 투여를 위한 항-CD38 항체의 제형
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