Merck Sharp + Dohme Corp.

Ashwin Basarkar

Ramesh Kashi

Sarita Mittal

Shuai Shi

Mohammed Shameem

Chakravarthy Nachu Narasimhan

Yogita Krishnamachari

Manoj K Sharma

Soumendu Bhattacharya

Wendy Benjamin

Shona P Patel

The invention relates to stable formulations of antibodies against human programmed death receptor PD-1, or antigen binding fragments thereof. In some embodiments the formulations of the invention comprise between 5-200 mg/mL anti-PD-1 antibody, or antigen binding fragment thereof. The invention further provides methods for treating various cancers with stable formulations of the invention. In some embodiments of the methods of the invention, the formulations are administered to a subject by intravenous or subcutaneous administration.

Stable formulations of programmed death receptor 1 (PD-1) antibodies and methods of use thereof

The invention provides stable liquid formulations for a recombinant biopharmaceutical protein comprising a soluble form of the human p75 TNF receptor fused to an Fe domain of a human immunoglobulin protein (TNFR:Fc). Typically, biopharmaceutical proteins such as monoclonal antibodies (mAbs) and immunoglobulin fusion proteins (e.g., immunoadhesion proteins) are produced by recombinant DNA technology in mammalian cell expression systems. In order to guarantee the reproducible clinical performance of a biopharmaceutical product, manufacturers have to deliver a product of consistent and reproducible quality.

Liquid formulations for TNFR:Fc fusion proteins

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Springfield, NJ, United States of America

Ashwin Basarkar