Siltuximab

Therapeutic Siltuximab antibody from the original Sylvant® commercial drug

BATCH NUMBER: KCI42014

Amount per aliquot: 2 mg

In stock

Product Specifications:​​

  • Quality Standard clinical-grade
  • Product Concentration 20 mg/mL
  • Volume per Aliquot 100 µL
  • Quantity per Aliquot 2 mg
  • Origin of the Commercial Drug DE
  • Batch Number KCI42014
  • Storage Temperature -70°C
  • Original Therapeutic Expiry Date 2023.02

Our products are for research use only. The “therapeutic expiration date” refers to the expiry date for patient adminstration and is not applicable to the shelf life of the aliquot. Aliquot storage at -70°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, aRMP, or 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 the recommended temperature -70°C, 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

Host cells

Chinese hamster ovary (CHO) cells

Prepared from (Reference drug)​

Sylvant®

Therapeutic Area

Mechanism of Action (MoA)

Siltuximab is a human-mouse chimeric monoclonal antibody that forms high affinity, stablecomplexes with soluble bioactive forms of human IL-6. Siltuximab prevents the binding of humanIL-6 to both soluble and membrane-bound IL-6 receptors (IL-6R), thus inhibiting the formation of thehexameric signaling complex with gp130 on the cell surface. Interleukin-6 is a pleiotropicpro-inflammatory cytokine produced by a variety of cell types including T-cells and B-cells,lymphocytes, monocytes and fibroblasts, as well as malignant cells. IL-6 has been shown to beinvolved in diverse normal physiologic processes such as induction of immunoglobulin secretion,initiation of hepatic acute phase protein synthesis, and stimulation of hematopoietic precursor cellproliferation and differentiation. Overproduction of IL-6, in chronic inflammatory diseases andmalignancies has been linked to anaemia and cachexia and has been hypothesised to play a central rolein driving plasma cell proliferation and systemic manifestations in patients with CD.

Pharmacotherapeutic group​​

Immunosuppresants, interleukin inhibitors

List of Excipients​

Histidine
Histidine hydrochloride monohydrate
Polysorbate 80
Sucrose

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