Edit

Evidentic offers repackaged finished pharmaceutical products known as drug aliquots. The abbreviation RMP – Reference Medicinal Products or Reference listed drug (US: RLD) refers to a commercially available and patent-protected original drug.   We refer to the RMP products repackaged by Evidentic synonymously as ‘drug aliquots’ (DA) or aRMP (=analytical RMP).

Procurement of original drug products (RMP).
As ‘raw material’ for the production of DA, 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. 

Production of drug aliquots (DA/aRMP) from RMP
DA are manufactured by repackaging RMP in a qualified laboratory. The DA manufacturing 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.

Labeling of DA/aRMP
For identification purposes, DAs 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.

Storage of DA/aRMP
Immediately after aliquoting, DAs are stored at either 2-8°C or -86°C for long-term storage. All DAs stored at 2-8°C are brought to -86°C after reaching the expiration date of the original RLD/RMP.

No further quality or functional testing will be performed on the DAs.

Edit

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 a specially designed aliquotation procedure, the therapeutic molecules  are stored at the conditions as recommended by the original manufacturer or alternatively stored at -80°C.

Regular drug aliquots are used as starting material for the diluted drug aliquots (dDA) diluted to 1 mg/ml. They are diluted in our GMP-certified laboratory to a final concentration of 1.0 mg/ml. A phosphate buffered saline buffer (PBS) pH 7.4 is used as diluent. The samples contain no preservatives (NaN3) and no additional BSA. After dilution, all samples are stored and frozen at -80°C.How many milligrams of therapeutic molecule does an drug aliquot or diluted drug aliquot contain?

Most drug aliquots contain between 0.1 – 12 mg of the original drug product (RMP). The concentration of the RMP 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.For diluted drug aliquots, the concentration is fixed at 1 mg/mL, for a 0,1 mg quantity of therapeutic molecule.

Edit

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. In order to increase the size of our library, we regularly inspect the market in search of new batches of the medications we have on stock.

To guarantee our clients that our products come indeed from different manufacturing batches, we always source products which expiry dates are separated by 3 months from one another. This way, we can provide the variety in biological and physiochemical characteristics that is relevant to our clients.

Edit

After aliquoting, half of the resulting aliquot batch is stored according to the manufacturer’s storage conditions for the original pharmaceutical product, so normally at 2-8°C. The second half is stored at -86°C.

Before the expiration date is reached, the batch that was originally stored at 2-8°C is transferred to -86°C as well. This ensures the integrity of the active ingredient and that the entire batch was stored BEFORE the end of the original expiration date.

As an example: if you find batches with an expiration date from the past (e.g. 06-2018), this batch has been aliquoted BEFORE June 2018 and transferred to -80°C at the latest by the end of June 2018.Are the batches stored at -80°C still usable for my experiments?

For long-term storage, we store drug aliquots at -86°C before the expiry date of the reference product. 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 frozen (Aliquot data sheet).

Our customers have used both 2-8°C and -86°C samples (including from “expired” batches) for their research. The functionality of the APIs for their experiments was demonstrated in their experiments.

Edit

Yes, it is! If you require it, we can send you the photos of the original filled-finished product, as we receive it.



Edit

For each product we currently have between one to six batches, the list shown on our site is exhaustive. 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: info@evidentic.com

Edit

Depending on demand and market availability, Evidentic prices may change. Prices are calculated dynamically and bulk prices are available. Please ask for a bulk price if it is not displayed on our website.

Edit

Our main activities are sourcing and subsequent aliquotation of the medicinal 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 2-8°C or -86°C in the GMP facility.

Examinations or analytical characterization is not performed on the aliqouts. SOP guidelines are followed at each step of the process.