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US 10,988,638 B2Granted
Process to reduce endotoxin in gelatin
AssigneeCatalent U.K. Swindon Zydis Limited
InventorsYik Teng Wong, Khojasteh Shirkhani, Ami Powe, Sarah Stewart, Charli Smardon
Life of this patent
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Abstract
The present disclosure is directed to processes for reducing the endotoxin level in gelatin and the resulting gelatin with low endotoxin content. The process includes dissolving a salt in a gelatin solution and filtering the gelatin-salt solution using anion exchange to reduce the endotoxin level. After reducing the endotoxin level of the gelatin-salt solution, the low endotoxin gelatin-salt solution is desalted to remove the salt, thereby producing a low endotoxin gelatin solution.
Claims18
A method for reducing endotoxin in gelatin, comprising:
- dissolving a salt in a gelatin solution comprising gelatin and a solvent to form a gelatin-salt solution, wherein the endotoxin content of the gelatin is at least 6,000 EU/g and a salt concentration in the gelatin-salt solution is 125-300 mM;
- filtering the gelatin-salt solution through an anion exchange adsorber such that a filtrate gelatin-salt solution has an endotoxin content of less than 2,500 EU/g;
- and
- desalting the filtrate gelatin-salt solution to form a low endotoxin gelatin solution that has an endotoxin content of less than 2,500 EU/g.
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Dependencies are inferred from the claim text.