Therapeutic EGFR-antibody from the original Erbitux® commercial drug targeting the EGFR-antigen, also referred to as Erbitux® or cetuximab 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.”
Cetuximab / Erbitux
|API type||Cetuximab is a chimeric monoclonal IgG1antibody produced in a mammalian cell line (Sp2/0) by recombinant DNA technology
|Pharmacotherapeutic group||Antineoplastic agents, monoclonal antibodie
|Target of antibody||EGFR; Synonyms: C-erb, CG10079, D-EGFR, D-Egf, DEGFR, DER, DER flb, DER/EGFR, DER/faint little ball, DER/top, DER/torpedo, DER1, DEgfr, Degfr, Der, DmHD-33, Dmel\\CG10079, EFG-R, EGFr, EGfr, EK2-6, Egf, Egf-r, EgfR, El, Elp, Elp-1, Elp-B1, Elp-B1RB1, HD-33, TOP, Torpedo/DER, Torpedo/Egfr, c-erbB, d-egf-r, dEGFR, dEGFR1, dEgfr, der, egfr, flb, l(2)05351, l(2)09261, l(2)57DEFa, l(2)57EFa, l(2)57Ea, mor1, top, top/DER, top/flb, torpedo/Egfr, torpedo/egfr, EGFR12, EGFR15, egfr1, Erbb2, ERBB, ERBB1, HER1, PIG61, mENA, ErbB-1, Errp, 9030024J15Rik, AI552599, Erbb, Errb1, Wa5, wa-2, wa2
(Mechanism of action; Source EMA document)
|Cetuximab is a chimeric monoclonal IgG1 antibody that is specifically directed against the epidermal growth factor receptor (EGFR).
EGFR signalling pathways are involved in the control of cell survival, cell cycle progression, angiogenesis, cell migration and cellular invasion/metastasis.
Cetuximab binds to the EGFR with an affinity that is approximately 5- to 10-fold higher than that of endogenous ligands. Cetuximab blocks binding of endogenous EGFR ligands resulting in inhibition of the function of the receptor. It further induces the internalisation of EGFR, which can lead to downregulation of EGFR. Cetuximab also targets cytotoxic immune effector cells towards EGFRexpressing tumour cells (antibody dependent cell-mediated cytotoxicity, ADCC).
Cetuximab does not bind to other receptors belonging to the HER family. The protein product of the proto-oncogene RAS (rat sarcoma) is a central down-stream signal transducer of EGFR. In tumours, activation of RAS by EGFR contributes to EGFR-mediated increased proliferation, survival and the production of pro-angiogenic factors.
RAS is one of the most frequently activated family of oncogenes in human cancers. Mutations of RAS genes at certain hot-spots on exons 2, 3 and 4 result in constitutive activation of RAS proteins independently of EGFR signaling.
|Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)||In both in vitro and in vivo assays, cetuximab inhibits the proliferation and induces apoptosis of human tumour cells that express EGFR. In vitro cetuximab inhibits the production of angiogenic factors by tumour cells and blocks endothelial cell migration. In vivo cetuximab inhibits expression of angiogenic factors by tumour cells and causes a reduction in tumour neo-vascularisation and metastasis.|
|Original license holder|
|Marketing authorisation numbers||EU/1/04/281/003
|Marketing authorisation holder||Merck KGaA
|Name of the manufacturer of the biological active substance||Merck KGaA
Frankfurter Straße 250
Boehringer Ingelheim Pharma GmbH & Co
Birkendorfer Str. 65
|Name and address of the manufacturer(s) responsible for batch release|
|Max shelf life||48 months
|Storage conditions||2°C – 8°C
|List of excipients||Sodium chloride
Citric acid monohydrate Sodium hydroxide
Water for injections