Therapeutic PD-1-antibody from the original Opdivo® commercial drug targeting the PD-1-antigen, also referred to as Opdivo® or nivolumab antibody. Research-relevant quantities are available as licence-free consumable in aliquoted or diluted variant. Therapeutic monoclonal antibodies can be used from researchers in in vitro and in vivo experiments, biosimilar developers can order different batches at the same time.
What our clients say
”Evidentic can supply different batches of reference products for precilinical research.The quick access to the on-stock batches allows for adhoc ordering, keeps costs down and makes a headstart possible!”
“Evidentic is a new source of cost-efficient therapeutic mAbs for our immonassays. And easy to order!”
“We develop innovative and biosimilar mAbs for a global market. Evidentic’s aRMPs are a great source of cost-efficient reference products for our research and development program.”
“Evidentic gives rapid access to originator biologics and different batches. For biosimilar developers and regulators, it will shorten the time to gauge the analytical acceptance range for multiple CQAs of biotherapeutics.”
Nivolumab / Opdivo
|API type||Nivolumab is produced in Chinese hamster ovary cells by recombinant DNA technology
|Pharmacotherapeutic group||Antineoplastic agents, monoclonal antibodies
|Target of antibody||PD-1; Synonyms: CD279, PD1, SLEB2, hPD-1, hPD-l, Ly101, Pdc1
(Mechanism of action; Source EMA document)
|Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody (HuMAb), which binds to the programmed death-1 (PD-1) receptor and blocks its interaction with PD-L1 and PD-L2. The PD-1 receptor is a negative regulator of T-cell activity that has been shown to be involved in the control of T-cell immune responses. Engagement of PD-1 with the ligands PD-L1 and PD-L2, which are expressed in antigen presenting cells and may be expressed by tumours or other cells in the tumour microenvironment, results in inhibition of T-cell proliferation and cytokine secretion. Nivolumab potentiates T-cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2 ligands. In syngeneic mouse models, blocking PD-1 activity resulted in decreased tumour growth.
Combined nivolumab (anti-PD-1) and ipilimumab (anti-CTLA-4) mediated inhibition results in improved anti-tumour responses in metastatic melanoma. In murine syngeneic tumour models, dual blockade of PD-1 and CTLA-4 resulted in synergistic anti-tumour activity.
|Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)|
|Original license holder|
|Marketing authorisation numbers||EU/1/15/1014/001 - 002
|Marketing authorisation holder||Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park
Uxbridge UB8 1DH
|Name of the manufacturer of the biological active substance||Bristol-Myers Squibb Company
6000 Thompson Road
East Syracuse, New York 13057
Lonza Biologics, Inc.
101 International Drive
Portsmouth, New Hampshire 03801
Samsung Biologics Co. Ltd.
Yeonsu-gu, Incheon, 21987
|Name and address of the manufacturer(s) responsible for batch release||Bristol-Myers Squibb S.r.l.
Loc. Fontana del Ceraso
03012 Anagni (FR)
|Max shelf life||24 months
|Storage conditions||2°C – 8°C
|List of excipients||Sodium citrate dihydrate