Daratumumab Hyaluronidase
- Therapeutic drugs as aliquots
- Multiple drug batches
- Consumable, so no license needed
- Prompt Delivery
- Fraction of the original drug price
BATCH NUMBER: AA0391A
Product Specifications:
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Quality Standard clinical-grade
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Product Concentration 120 mg/mL Daratumumab + 2000 IU/mL Hyaluronidase
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Volume per Aliquot 375 µL
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Quantity per Aliquot 45 mg Daratumimab + 750 IU Hyaluronidase
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Origin of the Commercial Drug US
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Batch Number AA0391A
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Storage Temperature -70 °C
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Original Therapeutic Expiry Date 2027.10
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
Isotype
Host cells
Prepared from (Reference drug)
Therapeutic Area
Therapeutic Indications
Mechanism of Action (MoA)
Pharmacotherapeutic group
List of Excipients
L-histidine hydrochloride monohydrate
α,α-Trehalose dihydrate
Polysorbate 20
Water for injection
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