Trastuzumab Emtansine

clinical grade

BATCH NUMBER: B3000H01

328,00 

Therapeutic Trastuzumab Emtansine antibody drug conjugate from the original Kadcyla ® commercial drug

In stock

Product specifications:​

  • Quality Standard clinical grade
  • Product Concentration 20 mg/mL
  • Volume per vial 100 µL
  • Quantity per vial 2 mg
  • Batch Number B3000H01
  • Storage Temperature 2-8°C / -80°C
  • Original therapeutic expiry date: 07/2023

Our products are for research use only. The “therapeutic expiration date” implies expiry date for patient adminstration and is not applicable to the shelf life of the aliquot. Aliquot storage at -86°C ensures fully functional molecules even after the mentioned expiry date.

Product Information:

Evidentic offers repackaged finished pharmaceutical products (e.g RMP/RLD). We refer to the repackaged RMP/RLD products synonymously as drug aliquots or aRMP, or short: aliquots.

We offer batches of original drug aliquots in low-binding Eppendorf tubes for research use only. We provide license-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.

As ‘raw material’ for the production of drug aliquots, Evidentic sources RMP from the European (EU) market. As a licensed pharmaceutical wholesaler, Evidentic is committed to Good Distribution Practice (GDP) compliance with respect to the procurement, storage and shipment of RMP.
Drug aliquots are manufactured by repackaging RMP in a qualified laboratory. The aliquotation process is performed under a quality and manufacturing agreement between Evidentic and the contract manufacturer. Repackaging of RMP includes the following steps: opening the secondary and primary RMP containers and transferring the specified volumes of RMP into an Eppendorf 0.5 ml low-binding (or similar) tube. If the RMP is a lyophilized powder and not a highly concentrated solution, reconstitute the RMP according to the original manufacturer’s instructions and then aliquot as a highly concentrated solution.
For identification purposes, drug aliquots are labeled with the date of aliquoting, the original lot number of the RMP, the original expiration date of the RMP, the name of the active ingredient (INN), and a unique identification code.
Immediately after aliquoting, drug aliquots are stored at either 2-8 °C or -86 °C for long-term storage. All drug aliquots stored at 2-8 °C are transferred to -86 °C at least two weeks before the expiration date of the original RLD/RMP is reached. Further quality or functional testing are not performed on the drug aliquots.  

Class of molecule

Isotype

Host cells

Chinese Hamster Ovary (CHO) cells

Prepared from (Reference drug)​

Kadcyla®

Therapeutic Area

Mechanism of Action (MoA)

Trastuzumab Emtansine, like trastuzumab, binds to domain IV of the HER2 extracellular domain (ECD), as well as to Fcγ receptors and complement C1q. In addition, inhibits shedding of the HER2 ECD, inhibits signalling through the phosphatidylinositol 3-kinase (PI3-K) pathway, and mediates antibody-dependent cell-mediated cytotoxicity (ADCC) in human breast cancer cells that overexpress HER2. DM1, the cytotoxic component of Trastuzumab Emtansine, binds to tubulin. By inhibiting tubulin polymerization, both DM1 and Trastuzumab Emtansine cause cells to arrest in the G2/M phase of the cell cycle, ultimately leading to apoptotic cell death.

Pharmacotherapeutic group​​

Antineoplastic agents

List of Excipients​

Succinic acid
Sodium hydroxide
Sucrose
Polysorbate 20

Batch specific analytical data available

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).

Trastuzumab Emtansine

BATCH NUMBER: B3000H01

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