Ibritumomab Tiuxetan

Name: Clinical-grade Ibritumomab Tiuxetan - Evidentic GmbH
Price: 2317.00 EUR
Availability: InStock

BATCH NUMBER: To be announced

2.317,00 €

Minimum order quantity: 7

Therapeutic Ibritumomab Tiuxetan from the original Zevalin® commercial drug

In stock

Drug Aliquots On Demand

*Subject to availability and market fluctuations.

Product specifications:

Product Concentration 1.6 mg/mL
Volume per vial 62.5 µL
Quantity per vial 0.1 mg
Batch Number to be announced
Storage Temperature 2-8 °C / -80 °C

Expiry Date: to be announced

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

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.

Procurement of original drug products (RMP).

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.

Production of drug aliquots from 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.

Labeling of drug aliquots

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.

Storage of drug aliquots

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.

Target

CD20

Class of molecule

Monoclonal Antibody

Isotype

IgG1

Host cells

Chinese hamster ovary (CHO) cell

Prepared from

Zevalin®

Therapeutic Area

Oncology

Therapeutic Indications

Follicular B-cell non-Hodgkin's lymphoma (NHL), Follicular lymphoma (FL)

Mechanism of Action (MoA)

Ibritumomab tiuxetan is a recombinant murine IgG1 kappa monoclonal antibody specific for the B-cell antigen CD20. Ibritumomab tiuxetan targets the antigen CD20 which is located on the surface of malignant and normal B-lymphocytes. During B-cell maturation, CD20 is first expressed in the midstage of B-lymphoblast (pre-B-cell), and is lost during the final stage of B-cell maturation to plasma cells. It is not shed from the cell surface and does not internalise on antibody binding.

Pharmacotherapeutic group

Various therapeutic radiopharmaceuticals

List of Excipients

Ibritumomab tiuxetan vial
Sodium chloride
Water for injections

Sodium acetate vial
Sodium acetate
Water for injections

Formulation buffer vial
Disodium phosphate dodecahydrate
Human albumin solution
Hydrochloric acid, diluted (for pH adjustment)
Pentetic acid
Potassium chloride
Potassium dihydrogen phosphate
Sodium chloride
Sodium hydroxide
Water for injections

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