Gemtuzumab ozogamicin

clinical grade

BATCH NUMBER: FM3513

1.127,00 €

Therapeutic Gemtuzumab ozogamicin antibody from the original Mylotarg® commercial drug
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Product specifications:​

  • Quality Standard clinical-grade
  • Product Concentration 1 mg/mL
  • Volume per vial 100 µL
  • Quantity per vial 0,1 mg
  • Origin of the commercial drug DE
  • Batch Number FM3513
  • Storage Temperature -80°C
  • Original therapeutic expiry date: 08/2024

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 license-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.  

Target

Class of molecule

Isotype

Host cells

Mammalian cell culture in NS0 cells

Prepared from (Reference drug)​

Mylotarg®

Therapeutic Area

,

Therapeutic Indications

Mechanism of Action (MoA)

Gemtuzumab ozogamicin is a CD33-directed ADC. Gemtuzumab is a humanised immunoglobulin class Gsubtype 4 (IgG4) antibody which specifically recognises human CD33. The antibody portion bindsspecifically to the CD33 antigen, a sialic acid-dependent adhesion protein found on the surface of myeloidleukaemic blasts and immature normal cells of myelomonocytic lineage, but not on normal haematopoieticstem cells. The small molecule, N-acetyl gamma calicheamicin, is a cytotoxic semisynthetic natural product.N-acetyl gamma calicheamicin is covalently attached to the antibody via an AcBut (4-(4-acetylphenoxy)butanoic acid) linker. Non-clinical data suggest that the anticancer activity of gemtuzumab ozogamicin is dueto the binding of the ADC to CD33-expressing cancer cells, followed by internalisation of the ADC-CD33complex, and the intracellular release of N-acetyl gamma calicheamicin dimethyl hydrazide via hydrolyticcleavage of the linker. Activation of N-acetyl gamma calicheamicin dimethyl hydrazide inducesdouble-stranded DNA breaks, subsequently inducing cell cycle arrest and apoptotic cell death.

Pharmacotherapeutic group​​

Antineoplastic agents

List of Excipients​

Dextran 40
Sucrose
Sodium chloride
Sodium dihydrogen phosphate monohydrate
Disodium hydrogen phosphate anhydrous

Batch specific analytical data available

Evidentic’s analytical service includes a comprehensive array of methods to support the drug development process, including, for example, structure, aggregation, degree of isomerization and N-glycans identification of the active pharmaceutical ingredient (API).

Gemtuzumab ozogamicin

BATCH NUMBER: FM3513

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Evidentic GmbH
Martin-Buber-Str. 10
14163 Berlin

+49 (0) 30 959 99 8831
info@evidentic.com

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