Follow these six easy steps, tab by tab, to learn how reference drugs are transformed into high-quality research consumables for analytical, in-vitro, and in-vivo use.
- 1. How do we obtain drugs?
- 2. Preparing drug aliquots
- 3. Storing aliquots
- 4. Drug batches / lots availability
- 5. Product documentation
- 6. How to order
- 7. Why buy aliquots
How do we obtain drugs?
As a licensed pharmaceutical wholesaler, we obtain finished monoclonal antibody (mAb) drugs from drug manufacturers and pharmaceutical wholesalers.
We work with a network of reliable wholesalers spread across the European Union. They provide us with a variety of drugs and their multiple batches. We take the time, effort, and stress out of the difficult mAb drug procurement process for you.
- Regulatory compliance: We control temperatures during drug transport from the pharmaceutical wholesaler to our laboratory. This is performed in accordance with the good distribution practice (GDP) guidelines.
- Consistent quality: You can rely on the original drug quality because we only purchase from licensed suppliers, strictly follow GDP guidelines for transport and storage of the drugs. We share with our customers all drug transport and storage temperature information.
Please note, Evidentic does not manufacture drugs, but we do source the drugs. At the Evidentic lab, technicians receive, divide, package, and store drugs for shipment.
Preparing drug aliquots
A single unit of a drug usually contains an excessive amount of active ingredient for most research purposes. At Evidentic, we divide the content of a drug vial into smaller amounts called aliquots. Dividing commercial drugs into smaller, practical amounts (aliquots) makes it more affordable and easier for you to source drugs. You can cut months into days from your procurement cycle by ordering mAb drugs aliquots directly from the Evidentic website.
- GMP-certified handling. Evidentic partners with a GMP-certified service laboratory, where vials of drugs are divided into smaller amounts (aliquotation). The lab’s trained personnel ensure that the drugs are handled in an appropriate and reproducible way.
- Global R&D clientele. Evidentic ships to research organizations worldwide. Shipment of these small quantities solve the problems of customs clearance associated with drug imports, providing easy availability of drugs to clients all over the globe.
Storing aliquots to maintain product quality
Once repackaged as aliquots, the drugs are stored in the GMP-certified service laboratory. There is only one way to ensure that a biologic is stable to use months to years after its nominal expiration date. That is to store it in a frozen state (-80°C) before the end of its shelf life. This storage temperature ensures that when thawed, the biologic recovers its previous stable state and behavior. All our freezers are GMP certified and regularly monitored.
- Liquid product: The mAb drug solution is divided into smaller quantities (aliquots). Half are sent to deep-freeze storage at -80°C. The other aliquots are put into refrigerated storage (5°C) until a few weeks before the product’s expiration date when remaining aliquots go into the deep freeze at -80°C.
- Freeze-dried product: Some manufacturers offer products as a freeze-dried/lyophilized powder. When this happens, technicians at our partner laboratory reconstitute the powder according to the manufacturer’s instructions. Then, they divide the solution into aliquots. Aliquots created from freeze-dried powder are put into deep-freeze storage (-80°C) immediately to ensure the long-term stability of the drug.
When buyers acquire drugs resuspended from freeze-dried powders, they avoid spending time to find and follow the manufacturer’s instructions for creating and storing the solution.
Drug batches / lots availability
To understand the variability of reference drug products during biosimilar development, it is important to compare different batches/lots of the drug. This becomes a problem for researchers because drug manufacturers usually release only a few batches of any biologic into the market each year.
- Flexible sourcing. Using Evidentic’s unique service you can overcome this limited-availability scenario. Evidentic buys several batches of each drug, makes aliquots, and stores them at -80°C. Clients can buy aliquots from different batches, released at different months or years, at the same time.
By using our batch drug library, investigators can eliminate the need to wait months/years to acquire a range of reference drug batches, dramatically reducing cost and time.
At Evidentic, we take pride in our quality assurance system. Thorough documentation provides complete traceability. Customers can easily follow back the contents of an aliquot to its original vial.
- End-to-end documentation: We document the drugs that we sell as aliquots at each stage of the supply chain. At the customer’s request, we even add pictures of drug labels and other important information to ensure complete traceability.
- Certificate of Analysis: Drug manufacturers release a certificate of analysis (CoA) report, which contains a quality assessment of the batch of the drug being released. These assessments measure the purity, safety, and potency of biologics drugs. These batch-specific reports are available for purchase on the Evidentic web site.
- Aliquot data sheet: The ADS report is our quality assurance document. It describes storage, handling, and shipping information of each aliquot. It does not measure drug characteristics, but it does provide a history of when and how aliquots passed along the supply chain. ADS information includes:
- Date, time, and temperature that the original drug arrived at the laboratory.
- Date and time that the drug was divided into aliquots.
- Confirmation of GDP compliance.
- Aliquot storage conditions.
- Download example Aliquot Data Sheet (ADS)
How to order
We can accept orders on our website (pay through PayPal or direct bank transfer) or through email (purchase orders or signed offers). Send us your request via email firstname.lastname@example.org or follow the steps to order on website. Read more here.
Why buy aliquots?
The procurement of even a single vial of a drug requires considerable time and energy. In addition, most of the mAb drugs are highly expensive and can only be purchased by a company holding wholesale or a GMP license. Evidentic solves all these problems by repackaging drugs in small quantities (aliquots). The aliquots can be ordered via the Evidentic website and delivered in a couple of days. They are available to any researcher worldwide, priced at a fraction of the single vial of a drug.
A special value proposition of Evidentic to biosimilar developers is the availability of a batch library. That is, multiple historic batches of drugs are available for purchase with just a few clicks.