The patent badge is an abbreviated version of the USPTO patent document. The patent badge does contain a link to the full patent document.
The patent badge is an abbreviated version of the USPTO patent document. The patent badge covers the following: Patent number, Date patent was issued, Date patent was filed, Title of the patent, Applicant, Inventor, Assignee, Attorney firm, Primary examiner, Assistant examiner, CPCs, and Abstract. The patent badge does contain a link to the full patent document (in Adobe Acrobat format, aka pdf). To download or print any patent click here.
Patent No.:
Date of Patent:
Jul. 03, 2012
Filed:
Aug. 22, 2008
Tongbo Jiang, Bedford, MA (US);
Cheryl Follo, Billerica, MA (US);
Maurice G. Phelan, Swampscott, MA (US);
Tongbo Jiang, Bedford, MA (US);
Cheryl Follo, Billerica, MA (US);
Maurice G. Phelan, Swampscott, MA (US);
EMD Millipore Corporation, Billerica, MA (US);
Abstract
The invention uses liquid chromatography-mass spectrometry to verify the presence or absence of the extractables introduced into a biopharmaceutical product during manufacture, filtration or storage at above a certain concentration. The method disclosed herein can be used to detect the presence of extractables in the actual biopharmaceutical product rather than a surrogate solvent system. Detection of the extractables in the actual drug product provides an accurate description of the leachables profile likely to be introduced to the human or animal patient. In one embodiment, the extractable are introduced by filtration of the bio-pharmaceutical product.