Patent: 10,241,117

Summary for Patent: 10,241,117

Title:	Methods for quantifying polypeptides using mass spectrometry
Abstract:	A method for identifying a polypeptide a specimen can include (i) treating a specimen suspected of including an insulin with a base; (ii) extracting a first fraction of the treated specimen by solid phase extraction using a mixed mode or polymeric reversed-phase media and a first solvent including an acid; (iii) separating a component of the first fraction by liquid chromatography using a chromatographic surface including a hydrophobic surface group and one or more ionizable modifiers, and a second solvent including an acid; and (iv) analyzing the component of the first fraction by mass spectroscopy, thereby identifying the polypeptide, if present, using a signal corresponding to a sequence fragment ion from the polypeptide. The signal can correspond to an intact multiply charged precursor fragment selected in a first quadrupole and its corresponding sequence fragment ion selected in a final quadrupole.
Inventor(s):	Chambers; Erin E. (North Brookfield, MA), Stapels; Martha (Bellingham, MA), Mather; Joanne (Millis, MA)
Assignee:	WATERS TECHNOLOGIES CORPORATION (Milford, MA)
Application Number:	15/965,613
Patent Claims:	see list of patent claims

Details for Patent 10,241,117

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986	June 07, 2000		2038-04-27
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986	January 19, 2001		2038-04-27
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986	April 23, 2004		2038-04-27
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986	October 31, 2013		2038-04-27
Sanofi-aventis U.s. Llc	LANTUS	insulin glargine	Injection	021081	April 20, 2000		2038-04-27
Sanofi-aventis U.s. Llc	LANTUS	insulin glargine	Injection	021081	April 25, 2007		2038-04-27
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536	June 16, 2005		2038-04-27