Cheryl A Follo

US Patent:

8436297, May 7, 2013

Filed:

Aug 22, 2008

Appl. No.:

12/674870

Inventors:

Tongbo Jiang - Bedford MA, US
Cheryl Follo - Billerica MA, US
Maurice G. Phelan - Swampscott MA, US

Assignee:

EMD Millipore Corporation - Billerica MA

International Classification:

H01J 49/00

US Classification:

250282, 210659

Abstract:

In accordance with an embodiment of the invention, there is provided a method for reducing or eliminating matrix interfering components in a biopharmaceutical product in a liquid chromatography-mass spectrometry system. The method comprises diverting to waste the entire flow of an eluant emerging from liquid chromatography of a sample, for a time period to remove contaminants that cause matrix interference to a degree sufficient to allow a desired accuracy in detection of an extractable; and, after the time period, directing the entire flow of the eluant to a mass spectrometer to detect the presence of the extractable.

US Patent:

20110278446, Nov 17, 2011

Filed:

Aug 22, 2008

Appl. No.:

12/674874

Inventors:

Tongbo Jiang - Bedford MA, US
Cheryl Follo - Billerica MA, US
Maurice G. Phelan - Swampscott MA, US

International Classification:

H01J 47/26

US Classification:

250282

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.