Detection and quantitation of cyclodextrins
AssigneeBiogen Idec MA Inc.
InventorsZoran Sosic, Rulin Qian, James Ahern, Rohin Mhatre
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Abstract
The invention relates to the detection and quantitation of cyclodextrins and cyclodextrin derivatives in solutions comprising a protein. The invention further relates to methods of evaluating pharmaceutical preparations for the presence of residual cyclodextrins.
Claims20
A method for recovering a cyclodextrin or cyclodextrin derivative from a solution comprising a protein recombinantly expressed in the presence of the cyclodextrin or cyclodextrin derivative, the method comprising loading the solution on a size exclusion chromatography (SEC) column, wherein the solution does not undergo a step of extraction prior to being loaded on the SEC column;
- separating the cyclodextrin or cyclodextrin derivative from the recombinantly expressed protein by SEC;
- contacting the cyclodextrin or cyclodextrin derivative with an agent that forms a detectable inclusion complex with the separated cyclodextrin or cyclodextrin derivative;
- and measuring the amount of a signal from the inclusion complex, wherein the signal is indicative of the quantity of the cyclodextrin or cyclodextrin derivative recovered from the solution.
Dependencies are inferred from the claim text.