WO2023021532 - A PROCESS TO PRODUCE A PHARMACEUTICAL COMPOSITION
National phase entry:
Publication Number
WO/2023/021532
Publication Date
23.02.2023
International Application No.
PCT/IN2022/050750
International Filing Date
19.08.2022
Title **
[English]
A PROCESS TO PRODUCE A PHARMACEUTICAL COMPOSITION
[French]
PROCÉDÉ DE PRODUCTION D'UNE COMPOSITION PHARMACEUTIQUE
Applicants **
DR. REDDY’S LABORATORIES LIMITED
Inventors
PUDIPEDDI, Akhila
PARUPUDI, L C Pavani
SWAYAMSIDDH, Saswat
KANNAN, Sneha
BANDYOPADHYAY, Suman
Priority Data
202141037886
20.08.2021
IN
Application details
| Total Number of Claims/PCT | * |
| Number of Independent Claims | * |
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| Number of Multi-Dependent Claims | * |
| Number of Drawings | * |
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International Searching Authority |
IP India
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| Recordal of a Change of the Applicant's Name/Address |
Change of Applicant's Name and Address
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| Type of Assignment |
The Standard Agent's Assignment
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| Applicant's Legal Status |
Legal Entity
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| * | |
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| Entry into National Phase under |
Chapter I
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| Patent Delivery |
Send the Letters Patent by Courier
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| Translation |
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Quotation for National Phase entry
| Country | Stages | Total | |
|---|---|---|---|
| China | Filing, Examination, Granting | 1954 | |
| EPO | Filing, Examination, Granting | 11600 | |
| Japan | Filing, Examination, Granting | 1993 | |
| South Korea | Filing, Examination, Granting | 1719 | |
| USA | Filing, Examination, Granting | 4740 |
Total:
22,006
The term for entry into the National Phase has expired. This quotation is for informational purposes only
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Abstract[English]
The present invention relates to a cell culture process for producing a monoclonal antibody composition, the process comprising culturing the mammalian cells at a pH range of about 6.6 to about 7.5, performing a temperature shift from a first culture temperature to a second culture temperature, supplementation of galactose in the cell culture, thereby obtaining an antibody composition comprising galactosylated glycoform and/or G0F glycoform. Further, the cell culture process disclosed in the present invention obtains an antibody composition comprising galactosylated glycoform wherein the percentage of galactosylated glycoform decreases with the decrease in the difference between the first temperature and the second temperature.[French]
La présente invention concerne un procédé de culture cellulaire pour produire une composition d'anticorps monoclonal, le procédé comprenant la culture des cellules de mammifères dans une gamme de pH d'environ 6,6 à environ 7,5, la réalisation d'un changement de température d'une première température de culture à une seconde température de culture, la supplémentation en galactose dans la culture cellulaire, obtenant ainsi une composition d'anticorps comprenant une glycoforme galactosylée et/ou une glycoforme G0F. En outre, le procédé de culture cellulaire divulgué dans la présente invention permet d'obtenir une composition d'anticorps comprenant une glycoforme galactosylée où le pourcentage de glycoforme galactosylée diminue avec la diminution de la différence entre la première température et la seconde température.