Process for the preparation of fidaxomicin
AssigneeConcord Biotech Limited
InventorsAnkur Sudhir Vaid, Mitesh Jagdishkumar Patel, Dhimant Punjalal Mehta, Anand Mahadev Dhiman, Jayesh Chandubhai Patel, Traunkant Parshuram Sharma
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Abstract
The present invention provides an improved process for the preparation of fidaxomicin by culturing Actinoplanes deccanensis in the culture medium of the invention wherein the fidaxomicin is produced in a yield of greater than 500 mg/L broth. The present invention also provides a whole broth extraction process for the isolation of fidaxomicin from the fermentation broth. The present invention also provides fidaxomicin having purity of greater than 97% area by HPLC.
Claims5
A process for the production of fidaxomicin comprising:
- providing a culture medium consisting essentially of,
- about 0.1% to about 15% wt of sorbitol,
- about 0.1% to about 10% wt of corn gluten,
- about 0.1% to about 15% wt of cane sugar,
- about 0.1% to about 5% wt of glycerol,
- about 0.1% to about 5% wt of soybean oil,
- about 0.1% to about 5% wt of soybean powder,
- about 0.1% to about 5% wt of dry yeast cell powder,
- about 0.05% to about 3% wt of CaCO3,
- about 0.05% to about 2% wt of MgSO4·7H2O,
- about 0.05% to about 2% wt of KC1, and
- about 0.01% to about 1% wt of K2HPO4;
- culturing a fidaxomicin producing microorganism using the culture medium to produce a fidaxomicin containing whole broth, wherein the fidaxomicin containing whole broth is produced without the use of an adsorbent resin;
- extracting the fidaxomicin containing whole broth using a water immiscible organic solvent, wherein fidaxomicin is extracted into the water immiscible organic solvent from the fidaxomicin containing whole broth;
- separating the water immiscible organic solvent layer;
- isolating the fidaxomicin from the water immiscible organic solvent layer, wherein the crude fidaxomicin is produced in a yield of greater than 1000 mg/L of broth;
- and
- purifying the isolated fidaxomicin using any one or more of column chromatography, preparative HPLC, and crystallization to produce fidaxomicin having a purity of greater than 98% when measured by HPLC.
Dependencies are inferred from the claim text.