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.
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.
Denosumab is a human monoclonal antibody (IgG2) that targets and binds withhigh affinity and specificity to RANKL, preventing the RANKL/RANK interaction from occurringand resulting in reduced osteoclast numbers and function, thereby decreasing bone resorption andcancer-induced bone destruction.
List of Excipients
Acetic acid, glacial*
Sodium hydroxide (for pH adjustment)*
Polysorbate 20 (* Acetate buffer is formed by mixing acetic acid with sodium hydroxide )