New Patent - Stable formula for Bex27 Jul 2023 21:49
New patent just out today -
https://patents.justia.com/patent/20230235046
Good to know this is all in hand - commercial manufacturing design nailed on .
No good having a product if it won't ship or store in stable state .
Stable storage formula for Bex for 3 months if stored at 2-8 degrees - although they have seen it stable after 2 years ( and expect it to last 3 years)
Patent covers liquid storage - preferred , but also cover for freeze dried stable storage too .
According to an exemplary embodiment of the present invention, a liquid antibody formulation can be made by taking the anti-CLEVER-1 antibody in liquid form and buffer exchanging it into the desired formulation. There is no lyophilization step in this embodiment. The drug substance in the final buffer is concentrated to a desired concentration. Excipients, such as trehalose dihydrate and polysorbate 20 are added to the solution and it is diluted using the appropriate buffer to final protein concentration. The final formulated drug substance is filtered using 0.22 μm filters and filled into a final container (e.g. glass vials).
According to an embodiment of the present invention, a formulation can also be a lyophilized formulation, i.e. lyophilisate. The term “lyophilisate” refers to the product of lyophilisation. The term “lyophilize” with regard to pharmaceutical formulations of the invention is intended to refer to freeze drying of a solution of the formulation. Lyophilized formulations of therapeutic proteins may provide advantages, such as better chemical stability. A lyophilized formulation may also be reconstituted at different concentrations depending on clinical factors, such as route of administration or dosing. The term “reconstitution” refers to dissolution of the lyophilisate for achieving an aqueous solution.
It has been observed that pharmaceutical formulation according to the present invention stabilize anti-CLEVER-1 antibodies or antigen binding fragment(s) thereof against degradation during storage. According to an embodiment of the present invention a formulation comprising an anti-CLEVER-1 antibody or antigen binding fragment(s) thereof has storage stability at 2-8° C. A good stability at high concentrations, even at concentrations of 100 mg/ml of anti-CLEVER-1 antibodies or antigen binding fragment(s) thereof can be achieved. A “stable” pharmaceutical formulation according to the present invention is a pharmaceutical formulation comprising an anti-CLEVER-1 antibody or antigen binding fragment(s) thereof with no significant changes observed at a refrigerated temperature 2-8° C. for at least 3 months. The formulation according to the invention has been observed to be storage stable at temperature of 2-8° C. for at least 18 months or 24 months. A pharmaceutical formulation is considered to be storage stable at temperature of 2-8° C. for even at least 30 months and even a period of 36 months.
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