Cellular-based method for determining the potency of defibrotide
AssigneeGentium S.R.L.
InventorsTerenzio Ignoni, Vijay Kumar, Claudio Verga
Life of this patent
Estimating the term…
Abstract
The present invention relates to cell-based methods for determining the biological activity of defibrotide. In particular, the invention provides a method for assessing the potency of defibrotide by assessing the viability of mammalian cells in the presence of at least one cytotoxic agent and one or more concentrations of defibrotide. Such methods are particularly useful for standardizing pharmaceutical compositions comprising defibrotide.
Claims21
A method of treating Veno-Occlusive Disease comprising administering to a patient in need thereof a pharmaceutical composition comprising defibrotide having a standardized potency, wherein the potency of the defibrotide is standardized by a method comprising the steps of:
- growing mammalian cells in culture;
- incubating the cells with a solution containing at least one cytotoxic agent and at least one concentration of a sample batch of defibrotide;
- measuring the viability of the cells after an incubation period;
- comparing the cell viability of the sample batch to the cell viability for a reference batch of defibrotide;
- and
- calculating the potency of the sample batch of defibrotide based on the comparison.
A method of treating Veno-Occlusive Disease comprising administering to a patient in need thereof a pharmaceutical composition comprising defibrotide having a standardized potency, wherein the potency of the defibrotide is standardized by a method comprising the steps of:
- growing mammalian cells in culture in a multi-well microtiter plate;
- incubating the cells with a solution containing at least one cytotoxic agent and at least four different concentrations of defibrotide from a sample batch;
- collecting dose response data points simultaneously;
- measuring the viability of the cells after an incubation period;
- comparing the cell viability for the at least four concentrations of the sample batch to the cell viability for a reference batch of defibrotide;
- and
- calculating the potency of the sample batch of defibrotide based on the comparison.
Dependencies are inferred from the claim text.