Galsulfase

clinical grade

BATCH NUMBER: L062084

565,00 €

Therapeutic Galsulfase enzyme from the original Naglazyme® commercial drug
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Product specifications:​

  • Quality Standard clinical-grade
  • Product Concentration 1,0 mg/mL
  • Volume per vial 200 µL
  • Quantity per vial 0,2 mg
  • Origin of the commercial drug DE
  • Batch Number L062084
  • Storage Temperature -80°C
  • Original therapeutic expiry date: 2023.07

Our products are for research use only. The “therapeutic expiration date” implies expiry date for patient administration 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

Chinese Hamster Ovary (CHO)

Prepared from (Reference drug)​

Naglazyme®

Therapeutic Area

Therapeutic Indications

Mechanism of Action (MoA)

Enzyme replacement therapy

Pharmacotherapeutic group​​

Enzymes

List of Excipients​

Sodium chloride
Sodium phosphate monobasic, monohydrate
Sodium phosphate dibasic, heptahydrate
Polysorbate 80
Water for injections

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).

Galsulfase

BATCH NUMBER: L062084

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  • Target research – Target identification, selection & validation
  • Planning and screening preparation
  • Lead generation – Screening preparation, hit generation, screening & lead selection
  • Lead optimization – Lead characterization, candidate selection
  • Preclinical development – PK/PD studies of candidate

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Evidentic GmbH
Am Mühlenberg 10

14476 Potsdam | Germany

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

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