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Title:
ANALYSIS METHOD AND ANALYSIS DEVICE
Document Type and Number:
Japanese Patent JP2016156807
Kind Code:
A
Abstract:
PROBLEM TO BE SOLVED: To provide an analysis method and an analysis device for analyzing a protein solution to estimate if suitable for a medical product using a Raman spectroscopy.SOLUTION: A Raman spectrum of a protein solution with a plurality of densities is obtained, an index changing according to interaction between protein molecules is calculated based on a predetermined peak included in the Raman spectrum, and a threshold value of the density by which the protein can be modified is specified based on the change of the index for density change. The specified threshold value and the density of the protein solution required as a medical product such as an antibody medicine are compared with each other, and whether the protein solution is suitable as a medical product is determined. For example, when the density required as a medical product is equal to or more than the specified threshold value, the protein solution is determined not to be suitable as a medical product. When the protein solution is not suitable as a medical product, the condition of the protein solution is changed, and even the analysis can be repeated.SELECTED DRAWING: Figure 1

Inventors:
TSUMOTO KOHEI
OTA CHIKASHI
NOGUCHI SHINTARO
Application Number:
JP2016013679A
Publication Date:
September 01, 2016
Filing Date:
January 27, 2016
Export Citation:
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Assignee:
HORIBA LTD
International Classes:
G01N21/65; G16B40/10
Domestic Patent References:
JP2005524849A2005-08-18
JP2009535627A2009-10-01
JP2007525662A2007-09-06
Foreign References:
US20050275837A12005-12-15
Other References:
OTA C , ET AL.: "Assessment of the Protein-Protein Interactions in a Highly Concentrated Antibody Solution by Using R", PHARM. RES., vol. 33, JPN6016035123, 16 December 2015 (2015-12-16), pages 956 - 969, XP035927679, ISSN: 0004248642, DOI: 10.1007/s11095-015-1842-8
OTA C, ET AL.: "The Molecular Interaction of a Protein in Highly Concentrated Solution Investigated by Raman Spectro", BIOPOLYMERS, vol. 103, no. 4, JPN6016035124, 22 November 2014 (2014-11-22), pages 237 - 246, XP055402658, ISSN: 0004248643, DOI: 10.1002/bip.22593
Attorney, Agent or Firm:
Hideno Kono
Nobuo Kono