Therapeutic PD-L1-antibody from the original Imfinzi® commercial drug targeting the PD-L1-antigen, also referred to as Imfinzi® or durvalumab antibody. Research-relevant quantities are available as licence-free consumable in an aliquoted 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.”
Durvalumab / Imfinzi
|API type||Durvalumab is a human monoclonal gG1κ antibody directed against the immunomodulatory cell surface ligand protein PD-L1 and produced in Chinese hamster ovary cells by recombinant DNA technology.
|Pharmacotherapeutic group||Antineoplastic agents, monoclonal antibodies
|Target of antibody||PD-L1; Synonyms: CD274, B7-H, B7H1, PD-L1, PDCD1L1, PDCD1LG1, PDL1, A530045L16Rik, B7h1, Pdcd1l1,
Pdcd1lg1, Pdl1, RGD1566211
|General function||IMFINZI as monotherapy is indicated for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose
disease has not progressed following platinum-based chemoradiation therapy. (Source EMA , package leaflet)
(Mechanism of action; Source EMA document)
|Expression of programmed cell death ligand-1 (PD-L1) protein is an adaptive immune response that
helps tumours evade detection and elimination by the immune system. PD-L1 can be induced by
inflammatory signals (e.g., IFN-gamma) and can be expressed on both tumour cells and
tumour-associated immune cells in tumour microenvironment. PD-L1 blocks T-cell function and
activation through interaction with PD-1 and CD80 (B7.1). By binding to its receptors, PD-L1 reduces
cytotoxic T-cell activity, proliferation and cytokine production.
Durvalumab is a fully human, immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that
selectively blocks the interaction of PD-L1 with PD-1 and CD80 (B7.1). Durvalumab does not induce
antibody dependent cell-mediated cytotoxicity (ADCC). Selective blockade of PD-L1/PD-1 and
PD-L1/CD80 interactions enhances antitumour immune responses and increases T-cell activation.
|Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)||Avelumab is a human immunoglobulin G1 (IgG1) monoclonal antibody directed against programmed death ligand 1 (PD-L1). Avelumab binds PD-L1 and blocks the interaction between PD-L1 and the programmed death 1 (PD-1) and B7.1 receptors. This removes the suppressive effects of PD-L1 on cytotoxic CD8+ T-cells, resulting in the restoration of anti-tumour T-cell responses.
Avelumab has also shown to induce natural killer (NK) cell-mediated direct tumour cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC).
|Original license holder|
|Marketing authorisation numbers||EU/1/18/1322/002
|Marketing authorisation holder||AstraZeneca AB
SE-151 85 Södertälje
|Name of the manufacturer of the biological active substance||AstraZeneca Pharmaceuticals LP
Frederick Manufacturing Center (FMC)
633 Research Court
Frederick, Maryland 21703 United States
|Name and address of the manufacturer(s) responsible for batch release||MedImmune UK Ltd
6 Renaissance Way
MedImmune Pharma B.V.
|Max shelf life||36 months
|Storage conditions||2°C – 8°C
|List of excipients||Histidine
Histidine hydrochloride monohydrate
Water for injections