Ipilimumab

Therapeutic Ipilimumab antibody from the original Yervoy® commercial drug

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Batch

Antigen
Molecular Class
Drug Brand
Product Concentration
CoA
Quantity per vial
Storage Temperature
Expiry Date
Price
CD152-CTLA4
Monoclonal Antibody
Yervoy®
5 mg/mL
yes
2 mg
-80°C
08/2021
952,00 
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Yervoy®/ Ipilimumab Reference Product

Drug nameYervoy®
INNIpilimumab
API typeIpilimumab is a fully human anti-CTLA-4 monoclonal antibody (IgG1κ) produced in Chinese hamster ovary cells by recombinant DNA technology.
Pharmacotherapeutic group
Antineoplastic agents, monoclonal antibodies
ATC code
L01XC11
Target of antibody
CD152-CTLA4
General functionIpilimumab is a CTLA-4 immune checkpoint inhibitor that blocks T-cell inhibitory signals induced by the CTLA-4 pathway, increasing the number of reactive T-effector cells which mobilize to mount a direct T-cell immune attack against tumour cells.
Short description
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
Cytotoxic T-lymphocyte antigen-4 (CTLA-4) is a key regulator of T-cell activity. Ipilimumab is a CTLA-4 immune checkpoint inhibitor that blocks T-cell inhibitory signals induced by the CTLA-4 pathway, increasing the number of reactive T-effector cells which mobilize to mount a direct T-cell immune attack against tumour cells. CTLA-4 blockade can also reduce T-regulatory cell function, which may contribute to an anti-tumour immune response.
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)Ipilimumab is an Antineoplastic agent, and may selectively deplete T-regulatory cells at the tumour site, leading to an increase in the intratumoral T-effector/ T-regulatory cell ratio which drives tumour cell death.
Original license holder
Bristol-Myers Squibb Pharma EEIG
Marketing authorisation numbers
EU/1/11/698/001-002
Marketing authorisation holder
Bristol-Myers Squibb Pharma EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland
Name of the manufacturer of the biological active substance
Bristol-Myers Squibb Company
6000 Thompson Road
East Syracuse, New York 13057
United States
Samsung Biologics Co. Ltd
300, Songdo Bio Way (Daero)
Yeonsu-gu, Incheon 21987
Korea
Name and address of the manufacturer(s) responsible for batch releaseCATALENT ANAGNI S.R.L.
Loc. Fontana del Ceraso snc
Strada Provinciale 12 Casilina, 41
03012 Anagni (FR)
Italy
Swords Laboratories T/A Bristol-Myers Squibb Cruiserath Biologics
Cruiserath Road, Mulhuddart
Dublin 15, D15 H6EF
Ireland
Max shelf life
3 years
Storage conditions
2°C – 8°C
List of excipients
Tris hydrochloride (2-amino-2-hydroxymethyl-1,3-propanediol hydrochloride)
Sodium chloride
Mannitol (E421)
Pentetic acid (diethylenetriaminepentaacetic acid)
Polysorbate 80
Sodium hydroxide (for pH-adjustment)
Hydrochloric acid (for pH-adjustment)
Evidentic Support
+49 (0) 30 959 99 8831

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