Therapeutic Trastuzumab deruxtecan ADC from the original Enhertu® commercial drug.
Product batch
| Expiry date
| Brand & Origin
| Price
| 1. Select quantity range | 2. Your quantity | |
|---|---|---|---|---|---|---|
2027.05 |
Enhertu® DE |
179,00Â €/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 | Herceptin® |
|---|---|
| INN | Trastuzumab |
| API type | One vial contains 150 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity and ion exchange chromatography including specific viral inactivation and removal procedures |
| Pharmacotherapeutic group | Antineoplastic agents, monoclonal antibodies |
| ATC code | L01XC03 |
| Target of antibody | HER2; Synonyms: CD340, HER-2, HER-2/neu, MLN 19, NEU, NGL, TKR1, Erbb-2, Neu, c-erbB2, c-neu, mKIAA3023, wu:fv70f10, zgc:63601, erb2 |
| General function | |
| Short description | |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | The pharmacokinetics of trastuzumab were evaluated in a population pharmacokinetic model analysis using pooled data from 1,582 subjects, including patients with HER2 positive MBC, EBC, AGC or other tumor types, and healthy volunteers, in 18 Phase I, II and III trials receiving Herceptin IV. A two-compartment model with parallel linear and non-linear elimination from the central compartment described the trastuzumab concentration-time profile. Due to non-linear elimination, total clearance increased with decreasing concentration. Therefore, no constant value for half-life of trastuzumab can be deduced. The t1/2 decreases with decreasing concentrations within a dosing interval (see Table 16). MBC and EBC patients had similar PK parameters (e.g. clearance (CL), the central compartment volume (Vc)) and population-predicted steady-state exposures (Cmin, Cmax and AUC). Linear clearance was 0.136 L/day for MBC, 0.112 L/day for EBC and 0.176 L/day for AGC. The non-linear elimination parameter values were 8.81 mg/day for the maximum elimination rate (Vmax) and 8.92 μg/mL for the Michaelis-Menten constant (Km) for the MBC, EBC, and AGC patients. The central compartment volume was 2.62 L for patients with MBC and EBC and 3.63 L for patients with AGC. In the final population PK model, in addition to primary tumor type, body-weight, serum aspartate aminotransferase and albumin were identified as a statistically significant covariates affecting the exposure of trastuzumab. However, the magnitude of effect of these covariates on trastuzumab exposure suggests that these covariates. |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | n/a |
| Original license holder | |
| Marketing authorisation numbers | EU/1/00/145/001 - 003 |
| Marketing authorisation holder | Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom |
| Name of the manufacturer of the biological active substance | Roche Diagnostics GmbH Pharma Biotech Penzberg Nonnenwald 2 D-82377 Penzberg Germany Genentech Inc. 1000 New Horizons Way Vacaville, CA 95688 USA Roche Singapore Technical Operations Pte. Ltd. 10 Tuas Bay Link 637394 Singapore Singapore Lonza Biologics Tuas Pte Ltd 35 Tuas South Ave. 6 637377 Singapore Singapore |
| Name and address of the manufacturer(s) responsible for batch release | Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany |
| Max shelf life | 48 months |
| Storage conditions | 2°C – 8°C |
| List of excipients | L-histidine hydrochloride L-histidine α,α-trehalose dihydrate polysorbate 20 |
Do you have any questions about the product, the ordering process or any other detail? Please contact us, we will reply within 24 hours.
At Evidentic, we deal with clinical-grade therapeutic molecules. Think of them as the building blocks for tomorrow’s groundbreaking treatments. These molecules are the active ingredients you’ll find in original drugs prescribed to patients, produced under the strictest quality and safety standards. They’ve also been therapeutically proven through rigorous clinical trials, meaning their effectiveness and safety for treating human diseases have been established. By offering researchers access to these essential tools, we’re fueling the fight for a healthier future.
Unlike some commercially available molecules, Evidentic’s clinical-grade therapeutics aren’t just research possibilities – they’re proven powerhouses! Derived from actual drugs used to treat human diseases, these molecules have already undergone rigorous testing and met the strictest safety and quality standards. This means researchers can focus their energy on groundbreaking discoveries, not questioning the reliability of their tools. With Evidentic, you get the confidence of knowing you’re working with the building blocks for real-world medical advancements.
If you struggle to source clinical-grade biologics you need for your research, Evidentic bridges the gap. We offer royalty-free research consumables (RUO-only) derived from original licensed drugs, giving you access to these critical research tools without the hassle.
But that’s not all. We understand the importance of batch variety in your research. That’s why we’ve built a comprehensive stock library, offering numerous batches of the same active pharmaceutical ingredient (API). This dedication to choice means you can find the exact batch that aligns with your specific research needs.
And because we’re constantly expanding our library, you can be sure we’re actively searching for new batches to add to your research arsenal. With Evidentic, unlock the power of readily available, high-quality research tools and accelerate your scientific breakthroughs.
Evidentic offers access to pharmaceuticals approved by the U.S. FDA (Food and Drug Administration) and/or the EMA (European Medicines Agency). This gives you access to a wider variety of molecules for your research, potentially shortening timelines and boosting the accuracy of your results. Compare EU and US molecules head-to-head, and accelerate your early drug development projects with access to these high-quality research tools. Contact us today to explore the possibilities!
Evidentic’s aliquots from approved pharnaceuticals can be used for analytical, in vitro research, typically executed in early drug development stage of drug discovery programs, like:
