Drug aliquots are small tubes (low-binding Eppendorf® or similar) that contain the original medicine in its original formulation. We do not produce the product inside the aliquot but divide the original vial’s content into small tubes. The aliquots are produced in a qualified laboratory (GMP).
All the original products (‘raw material’) used to produce the aliquots are sourced within the 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 the reference drugs.
The aliquots’ manufacturing process is performed under a quality and manufacturing agreement between Evidentic and the contract manufacturer. Repackaging of reference drugs includes the following steps: opening the secondary and primary containers and transferring the specified volumes of the reference product into an Eppendorf® 0.5 mL low-binding (or similar) tube. If the original product is a lyophilized powder and not a highly concentrated solution, the product is reconstituted according to the original manufacturer’s instructions and then aliquoted.
For quality and identification purposes, all aliquots are labelled with the date of aliquotation, the original batch number, the original expiration date, the name of the active ingredient (INN) of the original product as well as a unique identification code (more detailed info can be find under Quality).
Immediately after aliquoting, drug aliquots are stored at -80°C for long-term storage. In the past we have stored the aliquots in two different storage conditions – fridge (2-8 °C) and deep freeze (-80 °C) – but now all aliquots are stored in a deep freezer immediately after aliquotation.
No further quality or functional testing will be performed on the drug aliquots.
Once the original drug vial is received at Evidentic, the product undergoes a first quality control at our GDP-certified storage facility. In a second step, this quality control step is repeated at our GMP-certified aliquotation laboratory.
The product then undergoes a standardized aliquotation procedure. Following the aliquotation procedure, the therapeutic molecules are stored at -80°C.
Most drug aliquots contain between 0.1 – 12 mg of the original drug product. The concentration of the reference product remains unchanged, and the original drug buffer is also transferred during the aliquoting process. Typically, the volume of a drug aliquot is between 40 – 400 µl.
Our batches are exclusively sourced from the European market, mainly from the German market. Unfortunately, we don’t source products from the US-market.
As a Wholesaler, Evidentic is entitled to purchase original medicines from the EU / German wholesale market while complying to GDP rules throughout the entire process of procurement, storage, and shipment. To increase the size of our library, we regularly inspect the market in search of new batches of the medicines that we have in stock.
To guarantee our clients that our products come indeed from different manufacturing batches, we always source products which expiry dates are separated by at least 3 months from one another. This way, we can provide the variety in biological and physiochemical characteristics that is relevant to our clients.
Storage takes place in an alarm-protected freezer, within GMP conditions. Thus, the efficacy of the active ingredient is preserved, even long after the expiration of the original drug. With each of our vials, you will receive documentation indicating the exact day the aliquot was prepared and frozen (Aliquot Data Sheet – ADS).
For each product, we have between one to ten batches, and they are all displayed on our website. We can get in touch with you each time we receive additional batches from the products you are interested in. Please send us your information and request to: firstname.lastname@example.org.
We can also procure in the European Market extra batches or products specially for you through our dedicate service called Custom Aliquotation. In this case, you tell us your requirements and we will prepare an offer for you. Please note that in this case there is a minimum quantity of aliquots that you will have to purchase. This minimum order quantity will depend on several conditions, so it is not a fixed value for all the products. Please send us an email to email@example.com explaining your case and we will offer you a solution to your specific requirement.
Our main activity is sourcing and subsequent aliquotation of the reference products into analytical quantities. The product sourcing is performed under GDP guidelines – so temperature controlled – and aliquotation as well as storage of is done in GMP-licensed laboratory based in Germany. The aliquots are stored at -80°C in the GMP facility.
In case you require analytical data for the aliquots that we have, we offer this offer service at an additional cost. We teamed with a renowned Analytical CRO in Germany to provide this complementary service for the aliquots. To know more about this offer, please visit www.evidentic.com/analytical-data-service/.