Fremanezumab

Name: Fremanezumab - Evidentic GmbH
Price: 240.00 EUR
Availability: InStock

BATCH NUMBER: To be announced

240,00 €

Minimum order quantity: 8

Therapeutic Fremanezumab antibody from the original Ajovy® commercial drug

Drug Aliquots On Demand

*Subject to availability and market fluctuations.

Product specifications:

Product Concentration 150 mg/mL
Volume per vial 40 µL
Quantity per vial 6 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

CGRP ligand

Class of molecule

Monoclonal Antibody

Isotype

Humanised IgG2Δa/kappa

Host cells

Chinese Hamster Ovary (CHO) cells

Prepared from

Ajovy®

Therapeutic Area

Neurological Diseases

Therapeutic Indications

Prophylaxis of migraine

Mechanism of Action (MoA)

Calcitonin gene-related peptide (CGRP) antagonist

Pharmacotherapeutic group

Fremanezumab selectively binds the calcitonin gene-related peptide (CGRP) ligand and blocks bothCGRP isoforms (α-and β-CGRP) from binding to the CGRP receptor. While the precise mechanism of 6action by which fremanezumab prevents migraine attacks is unknown, it is believed that prevention ofmigraine is obtained by its effect modulating the trigeminal system. CGRP levels have been shown toincrease significantly during migraine and return to normal with headache relief

List of Excipients

L-histidine
L-histidine hydrochloride monohydrate
Sucrose
Disodium ethylenediaminetetraacetic acid (EDTA) dihydrate
Polysorbate 80 (E 433)

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