Therapeutic Pembrolizumab antibody from the original Keytruda® commercial drug.
Product batch
| Expiry date
| Brand & Origin
| Price
| 1. Select quantity range | 2. Your quantity | |
|---|---|---|---|---|---|---|
2018.07 |
Keytruda® DE |
264,00 €
/mg
|
Select quantity:
|
mg |
||
2018.12 |
Keytruda® DE |
264,00 €
/mg
|
Select quantity:
|
mg |
||
2019.03 |
Keytruda® DE |
264,00 €
/mg
|
Select quantity:
|
mg |
||
2019.07 |
Keytruda® DE |
264,00 €
/mg
|
Select quantity:
|
mg |
||
2025.10 |
Keytruda® DE |
198,00 €/mg
|
mg |
Evidentic’s analytical service includes a comprehensive array of methods to support the drug development process, including, for example, structure, aggregation, degree of isomerization and N-glycans identification of the active pharmaceutical ingredient (API).
Here you will find the product information for the reference product.
| Drug name | Keytruda® |
| INN | Pembrolizumab |
| API type | Pembrolizumab is a humanized monoclonal anti-programmed cell death-1 (PD-1) antibody (IgG4/kappa isotype with a stabilizing sequence alteration in the Fc region) produced in Chinese hamster ovary cells by recombinant DNA technology |
| Pharmacotherapeutic group | Antineoplastic agents, monoclonal antibodies |
| ATC code | L01XC18 |
| Target of antibody | PD-1; Synonyms: CD279, PD1, SLEB2, hPD-1, hPD-l, Ly101, Pdc1 |
| General function | Pembrolizumab is a humanized monoclonal antibody which binds to the programmed cell death-1 (PD-1) receptor and blocks its interaction with ligands PD-L1 and PD-L2. |
| Short description | |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | 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. Pembrolizumab potentiates T-cell responses, including anti-tumor responses, through blockade of PD-1 binding to PD-L1 and PD-L2, which are expressed in antigen presenting cells and may be expressed by tumors or other cells in the tumor microenvironment. |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | No formal pharmacokinetic drug interaction studies have been conducted with pembrolizumab. Since pembrolizumab is cleared from the circulation through catabolism, no metabolic drug-drug interactions are expected. The use of systemic corticosteroids or immunosuppressants before starting pembrolizumab should be avoided because of their potential interference with the pharmacodynamic activity and efficacy of pembrolizumab. However, systemic corticosteroids or other immunosuppressants can be used after starting pembrolizumab to treat immune-related adverse reactions. |
| Original license holder | Merck Sharp & Dohme B.V. Waarderweg 39 2031 BN Haarlem The Netherlands |
| Marketing authorisation numbers | EU/1/15/1024/002 |
| Marketing authorisation holder | Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom |
| Name of the manufacturer of the biological active substance | MedImmune, LL C Frederick Manufacturing Center (FMC) 633/636/660 Research Court Frederick MD 21703-8619, USA Boehringer Ingelheim (BIB) Pharma GmbH & Co. KG Birkendorfer Straße 65 88397 Biberach an der Riss Germany |
| Name and address of the manufacturer(s) responsible for batch release | Schering-Plough Labo NV Industriepark 30, Heist-op-den-Berg B-2220, Belgium |
| Max shelf life | 24 months |
| Storage conditions | 2°C – 8°C |
| List of excipients | L-histidine L-histidine hydrochloride monohydrate Sucrose Polysorbate 80 |
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