Formulations of anti-CD38 antibodies for subcutaneous administration

• Main Authors: PEREZ-RAMIREZ BERNARDO, CHARI RAVI, PHILIPPE VICTORIA, BARRETT TRISTAN, WHEELER SAMUEL, BANGARI KANNAN
• Format: Patent
• Language: Chinese; English
• Published: 03.02.2023
• 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

Formulations of anti-CD38 antibodies suitable for subcutaneous administration to a subject in need thereof are provided. The formulations include high concentrations of antibodies, viscosity reducers, stabilizers, buffers, and surfactants. In certain embodiments, the viscosity of the solution is at most 25 mPa.s, and the pH of the solution is from 5.9 to 7.0. In certain embodiments, the anti-CD38 antibody is an istuximab. The formulations are useful in the treatment of CD38 + hematological malignancies, including multiple myeloma, in humans as well as autoimmune and inflammatory diseases. 提供了适合于皮下施用给有需要的受试者的抗CD38抗体的配制品。所述配制品包括高浓度的抗体、降粘剂、稳定剂、缓冲剂和表面活性剂。在某些实施方案中，溶液的粘度最多为25mPa·s，且所述溶液的pH为5.9至7.0。在某些实施方案中，所述抗CD38抗体是伊沙妥昔单抗。所述配制品可用于治疗人类的包括多发性骨髓瘤在内的CD38+血液恶性肿瘤以及自身免疫疾病和炎性疾病。