Anifrolumab

Name: Anifrolumab - Evidentic GmbH
Price: 393.00 EUR
Availability: InStock

BATCH NUMBER: To be announced

393,00 €

Minimum order quantity: 8

Therapeutic Anifrolumab monoclonal antibody from the original Saphnelo® commercial drug

Drug Aliquots On Demand

*Subject to availability and market fluctuations.

Product specifications:

Product Concentration 150 mg/mL
Volume per vial 50 µL
Quantity per vial 7,5 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

IFNAR1

Class of molecule

Monoclonal Antibody

Isotype

IgG1/kappa

Host cells

Mouse myeloma cells (NS0) by recombinant DNA technology

Prepared from

Saphnelo®

Therapeutic Area

Lupus

Therapeutic Indications

Active autoantibody-positive systemic lupus erythematosus (SLE)

Mechanism of Action (MoA)

Anifrolumab is a human immunoglobulin G1 kappa monoclonal antibody that binds to subunit 1 of the type I interferon receptor (IFNAR1) with high specificity and affinity. This binding inhibits type I IFN signalling thereby blocking the biologic activity of type I IFNs. Anifrolumab also induces the internalisation of IFNAR1, thereby reducing the levels of cell surface IFNAR1 available for receptor assembly. Blockade of receptor mediated type I IFN signalling inhibits IFN responsive gene expression as well as downstream inflammatory and immunological processes. Inhibition of type I IFN blocks plasma cell differentiation and normalises peripheral T-cell subsets, restoring the balance between adaptive and innate immunity that is dysregulated in SLE.

Pharmacotherapeutic group

Immunosuppressants, Selective immunosuppressants

List of Excipients

Histidine
Histidine hydrochloride monohydrate
Lysine hydrochloride
Trehalose dihydrate
Polysorbate 80
Water for injections

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