Formulations of immune check point inhibitors
AssigneeDr. Reddy;S Laboratories Ltd.
InventorsMurali JAYARAMAN, Saisharan K GOUD, Sunil ASHOK NANKAR, Asif RASUL SAYYAD, Suman LABALA, Mahesh INGALE
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Abstract
The present invention relates to pharmaceutical formulations of antibodies and antigen-binding fragments against human programmed death receptor-1 (PD-1) or programmed death receptor Ligand 1 (PD-L1), and method for preparing the same. The disclosed formulations are free of sugar or sugar alcohol and stabilizes anti-PD1/anti-PD L1 antibody from lower to higher concentrations rendering it suitable for different modes of administration (subcutaneous/intravenous).
Claims11
A pharmaceutical formulation of an anti-PDI antibody or an anti-PD L1 antibody comprising:
- i. an anti-PDI or an anti-PD L1 antibody,
- ii. 10-50 mM succinate or acetate buffer,
- iii. poly ethylene glycol (PEG) or propylene glycol,
- iv. a surfactant, and,
- wherein the formulation does not contain any sugar or sugar alcohol.
Dependencies are inferred from the claim text.