Title:
ANALYSIS METHOD AND ANALYZING DEVICE
Document Type and Number:
WIPO Patent Application WO/2017/130433
Kind Code:
A1
Abstract:
Provided are an analysis method and an analyzing device for analyzing a protein solution using Raman spectroscopy in order to evaluate whether the protein solution is suitable for use as a pharmaceutical product.
Raman spectra of protein solutions having a plurality of concentrations are obtained, an index which varies in accordance with interactions between protein molecules is calculated on the basis of predetermined peaks included in the Raman spectra, and a concentration threshold at which the protein may be denatured is identified on the basis of variations in the index with respect to variations in the concentration. The identified threshold is compared with a protein solution concentration required for the protein solution to be used as a pharmaceutical product such as an antibody pharmaceutical product, to determine whether the protein solution is suitable for use as a pharmaceutical product. For example, if the concentration required for the protein solution to be used as a pharmaceutical product is equal to or greater than the identified threshold, it is determined that the protein solution is not suitable for use as a pharmaceutical product. If the protein solution is not suitable for use as a pharmaceutical product, the protein solution conditions may be changed and the analysis repeated.
Inventors:
TSUMOTO KOUHEI (JP)
OTA CHIKASHI (JP)
NOGUCHI SHINTARO (JP)
OTA CHIKASHI (JP)
NOGUCHI SHINTARO (JP)
Application Number:
PCT/JP2016/068363
Publication Date:
August 03, 2017
Filing Date:
June 21, 2016
Export Citation:
Assignee:
HORIBA LTD (JP)
International Classes:
G01N21/65; G01N33/15; G16B40/10
Foreign References:
| JP2005524849A | 2005-08-18 | |||
| JP2009535627A | 2009-10-01 | |||
| JP2007525662A | 2007-09-06 | |||
| US20050275837A1 | 2005-12-15 |
Other References:
OTA C ET AL.: "Assessment of the Protein- Protein Interactions in a Highly Concentrated Antibody Solution by Using Raman Spectroscopy", PHARM. RES., vol. 33, no. 4, 16 December 2015 (2015-12-16), pages 956 - 969, XP035927679, Retrieved from the Internet
OTA C ET AL.: "The Molecular Interaction of a Protein in Highly Concentrated Solution Investigated by Raman Spectroscopy", BIOPOLYMERS, vol. 103, 22 November 2014 (2014-11-22), pages 237 - 246, XP055402658, Retrieved from the Internet
See also references of EP 3410100A4
OTA C ET AL.: "The Molecular Interaction of a Protein in Highly Concentrated Solution Investigated by Raman Spectroscopy", BIOPOLYMERS, vol. 103, 22 November 2014 (2014-11-22), pages 237 - 246, XP055402658, Retrieved from the Internet
See also references of EP 3410100A4
Attorney, Agent or Firm:
KOHNO, Hideto et al. (JP)
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