Trastuzumab Emtansine Drug Aliquot | Anti-HER2 | Therapeutic ADC

Aliquoted from the original reference drug | Now available for research use

Aliquots of the reference drug Trastuzumab Emtansine are now available as research consumables.

Trastuzumab Emtansine drug aliquots can be used for in vitro or in vivo experiments. For biosimilar development, different batches of Trastuzumab Emtansine drug can be ordered at the same time. Several other reference drugs are also available.

The drug aliquots are generated by aliquoting (dividing and repackaging) the EU-licensed reference drug.

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Up to 10 batches of original drugs for examining batch-to-batch variations

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Kadcyla® / Tratuzumab Emtansine

Drug nameKadcyla®
INNTrastuzumab emtansine
API typeTrastuzumab emtansine is an antibody-drug conjugate that contains trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture, covalently linked to DM1, a microtubule inhibitor, via the stable thioether linker MCC (4-[N-maleimidomethyl] cyclohexane-1-carboxylate)
Pharmacotherapeutic groupAntineoplastic agents, other antineoplastic agents, monoclonal
ATC codeL01XC14
Target of antibodyHER2
General functionTrastuzumab emtansine, as a single agent, is indicated for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy. Is also indicated for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a
taxane, separately or in combination.
Short description
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
Trastuzumab emtansine, trastuzumab emtansine, is a HER2-targeted antibody-drug conjugate which contains the humanised anti-HER2 IgG1, trastuzumab, covalently linked to the microtubule inhibitor DM1 (a maytansine derivative) via the stable thioether linker MCC (4-[N-maleimidomethyl] cyclohexane-1-carboxylate). Emtansine refers to the MCC-DM1 complex. An average of 3.5 DM1 molecules are conjugated to each molecule of trastuzumab.
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)The population pharmacokinetic analysis suggested no difference in trastuzumab emtansine exposure based on disease status (adjuvant vs. metastatic setting)
Original license holder
Marketing authorisation numbersEU/1/13/885/001
Marketing authorisation holderRoche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany
Name of the manufacturer of the biological active substanceLonza Ltd.
Lonzastrasse
CH-3930 Visp
Switzerland
Name and address of the manufacturer(s) responsible for batch releaseRoche Pharma AG
Emil-Barell-Strasse 1
D-79639 Grenzach-Whylen
Germany
Max shelf life3 years
Storage conditions2°C – 8°C
List of excipientsSuccinic acid
Sodium hydroxide
Sucrose
Polysorbate 20

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Evidentic offers multiple batches of original drug aliquots in low binding Eppendorf tubes for research use only. We provide licence-free drug aliquots with long, short or even “negative shelf life” by storing the products at recommended temperatures (either 2-8°C or -80°C) and ensuring fully functional molecules for research purposes.

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