Necitumumab

BATCH NUMBER: To be announced

217,00 

Minimum order quantity: 7

Therapeutic Necitumumab antibody from the original Portrazza® commercial drug

Drug Aliquots On Demand

Product specifications:​

  • Product Concentration 16 mg/mL
  • Volume per vial 375 µL
  • Quantity per vial 6 mg
  • Batch Number to be announced
  • Storage Temperature 2-8 °C / -80 °C
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 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.

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

Murine cells

Prepared from

Portrazza ®

Therapeutic Area

Therapeutic Indications

Mechanism of Action (MoA)

Necitumumab is a recombinant human IgG1 monoclonal antibody that binds with high affinity andspecificity to the human epidermal growth factor receptor 1 (EGFR) and blocks the ligand bindingsite, blocking activation by all known ligands and inhibiting relevant biological consequences in vitro.Activation of EGFR has been correlated with malignant progression, induction of angiogenesis andinhibition of apoptosis or cell death. In addition, necitumumab induces EGFR internalization anddegradation in vitro. In vivo studies in cell line-derived xenograft models of human cancer, includingnon-small cell lung carcinoma, demonstrate that necitumumab has antitumor activity both inmonotherapy and in combination with gemcitabine and cisplatin.

Pharmacotherapeutic group​​

Antineoplastic agents, monoclonal antibodies

List of Excipients​

Sodium citrate dihydrate (E331), Citric acid anhydrous (E330), Sodium chloride, Glycine (E640), Mannitol (E421), Polysorbate 80 (E433), Water for injections

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+49 (0) 30 959 99 8831

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