How do we source pharmaceuticals?
As a licensed pharmaceutical wholesaler, we source finished medicines from drug manufacturers and pharmaceutical wholesalers.
We cooperate with a network of reliable wholesalers distributed throughout the European Union. They supply us with a wide range of medicines and their different batches. We reduce the time, effort and stress of the difficult process of procuring medications.
- Regulatory Compliance: We control temperatures during drug transport from pharmaceutical wholesalers to our lab. This is done in accordance with Good Distribution Practice (GDP) guidelines.
- Consistent Quality: You can rely on the original quality of the drugs as we only purchase from licensed suppliers and strictly follow the GDP guidelines for transport and storage of the drugs. Together with our customers we share all information about the transportation and up to the storage temperature of the medicines.
Evidentic does not manufacture therapeutic molecules itself, but instead obtains commercially available drugs for repackaging in microcentrifuge tubes.
Preparation of drug aliquots
- GMP-certified processing: Evidentic works with a GMP-certified service lab where drug vials are divided into smaller quantities (aliquoting). The lab's trained staff ensures that the drugs are handled in an appropriate and reproducible manner.
- Global R&D customer base: Evidentic ships to research organizations worldwide. Shipping these small quantities solves the customs clearance issues associated with importing drugs and allows easy availability of drugs to customers around the world.
Storing drug aliquots to maintain product quality
After repackaging in Drug Aliquots, the drugs are stored in the GMP-certified service laboratory. There is only one way to ensure that a biologic is still usable months to years after its nominal expiration date. That is to store it in a frozen state (-86°C) before the end of its shelf life. This storage temperature ensures that the biologic will regain its previous active state and behavior upon thawing. All our freezers are GMP certified and regularly monitored.
- Liquid product: the drug solution is divided into smaller quantities (drug aliquots). Half of them are stored frozen at -86°C. The other Drug Aliquots are stored refrigerated (5°C) until a few weeks before the expiration date of the original drug, when the remaining Drug Aliquots are also transferred to the freezer at -86°C.
- Freeze-dried product: some manufacturers offer products as freeze-dried/lyophilized powder. In this case, our partner laboratory staff reconstitute the powder according to the manufacturer's instructions. They then divide the solution into drug aliquots. Drug Aliquots prepared from the freeze-dried powder are immediately stored frozen (-86°C) to ensure long-term stability of the drug.
When buyers purchase drugs resuspended from freeze-dried powders, they save the time of finding and following the manufacturer’s instructions for preparing and storing the solution.
Availability of drug batches
To understand the variability of reference drugs during biosimilar development, it is important to compare different batches of the drug. This becomes a problem for researchers as drug manufacturers typically launch only a few batches of a biologic per year.
- Flexible procurement: Evidentic's unique service allows you to overcome this scenario of limited availability. Evidentic purchases multiple batches of each drug, manufactures Drug Aliquots and stores them at -86°C. Customers can purchase Drug Aliquots from different batches released in different months or years at the same time.
By using our batch drug library, researchers no longer have to wait months/years to purchase a series of reference drug batches, dramatically reducing cost and time.
Product Documentation
At Evidentic, we take pride in our quality assurance system. Thorough documentation ensures complete traceability. Customers can easily trace the contents of a Drug Aliquot back to its original vial.
- End-to-end documentation: we document the drugs we sell as Drug Aliquots at every stage of the supply chain. At the customer's request, we even include images of drug labels and other important information to ensure full traceability
- Certificate of Analysis: Drug manufacturers issue a Certificate of Analysis (CoA), which provides a quality assessment of the batch of drug released. These assessments measure the purity, safety, and potency of biologic drugs. These batch-specific reports can be purchased on the Evidentic website.
- Aliquot Data Sheet: The ADS report is our quality assurance document. It describes storage, handling, and shipping information for each aliquot. It does not measure drug properties, but it does provide a history of when and how aliquots passed through the supply chain. ADS information includes:
- Date, time and temperature the original drug arrived at the lab.
- Date and time the drug was split into aliquots.
- Confirmation of GDP compliance.
- Aliquot storage conditions.
- Download sample Aliquot Data Sheet (ADS)