WO2023057994 - SEPARATION OF PRE-PEAK IN FUSION PROTEIN SAMPLE BY USING SIZE EXCLUSION HIGH PERFORMANCE LIQUID CHROMATOGRAPHY
National phase entry:
Publication Number
WO/2023/057994
Publication Date
13.04.2023
International Application No.
PCT/IB2022/059648
International Filing Date
08.10.2022
Title **
[English]
SEPARATION OF PRE-PEAK IN FUSION PROTEIN SAMPLE BY USING SIZE EXCLUSION HIGH PERFORMANCE LIQUID CHROMATOGRAPHY
[French]
SÉPARATION DE PRÉ-PIC DANS UN ÉCHANTILLON DE PROTÉINE DE FUSION AU MOYEN D'UNE CHROMATOGRAPHIE LIQUIDE HAUTE PERFORMANCE PAR EXCLUSION DE TAILLE
Applicants **
KASHIV BIOSCIENCES, LLC
20, New England Avenue
Piscataway, New Jersey 08854, US
Inventors
UPADHYAY, Roshan Ganeshlal
NE/36, Shivanand Apartment,
K K Nagar road, Ghatlodia,
Ahmedabad,
Gujarat
Ahmedabad 380061, IN
MANIAR, Darshana Jiten
B-101 Sopan, Near club O7, Opp. S.P.Ring road, Ahmedabad, Gujarat
Ahmedabad 380058, IN
SINGH, Shivani
103/1, Shaktinagar society, Dental college road, Ahmedabad, Gujarat
Ahmedabad 380058, IN
Priority Data
202121045943
08.10.2021
IN
Application details
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International Searching Authority |
USPTO
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| Applicant's Legal Status |
Legal Entity
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| Entry into National Phase under |
Chapter I
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| Translation |
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Quotation for National Phase entry
| Country | Stages | Total | |
|---|---|---|---|
| China | Filing | 1274 | |
| EPO | Filing, Examination | 7850 | |
| Japan | Filing | 594 | |
| South Korea | Filing | 575 | |
| USA | Filing, Examination | 2280 |
Total: 12573 USD
The term for entry into the National Phase has expired. This quotation is for informational purposes only
Abstract[English]
The present invention provides an effective High Performance Liquid Chromatography (SE-HPLC) method to separate or resolve the pre-peak and main peak (fusion protein). The method provides improved sharpness and resolution of pre-peak impurity. The method provides pre-peak area not less than 1.0 and resolution more than 1.3 in SE-HPLC. Moreover, the present invention also provides the method for the estimation and/or quantification of pre-peak and main peak of the protein mixture.[French]
La présente invention concerne un procédé de chromatographie liquide haute performance (SE-HPLC) efficace pour séparer ou résoudre le pré-pic et le pic principal (protéine de fusion). Le procédé permet d'obtenir une netteté et une résolution améliorées de l'impureté de pré-pic. Le procédé fournit une zone de pré-pic qui n'est pas inférieure à 1,0 et une résolution supérieure à 1,3 en SE-HPLC. De plus, la présente invention concerne également le procédé d'estimation et/ou de quantification de pré-pic et de pic principal du mélange de protéines.