Frequently Asked Questions
Therapeutic antibodies are developed for the treatment of human diseases. They are the active ingredient of original drugs, prescribed to human patients for treatment of various diseases, typically cancer. They target antigens like HER2, TNFa or CD20 etc and their therapeutic function was proven in clinical trials.
Therapeutic antibodies differ from diagnostic or research antibodies because they are derived from actual drugs used for humans. Here are some characteristics that distinguish therapeutic antibodies (th-mAbs) from research-use-only antibodies (RUO-Abs): please refer to our blog entry (link).
For researchers, therapeutic molecules such as antibodies are usually difficult to obtain. At Evidentic, you can purchase therapeutic molecules and antibodies from original EU-licensed drugs as royalty-free consumables for research (RUO-only).
For customers who need different batches, we have built a stock library to offer numerous batches of the same API (active pharmaceutical ingredient). To increase the size of our library, we regularly scout the market for new batches of our in-stock drugs.
You may be able to find other antibodies on the market, but they will not be therapeutic, meaning that their effectiveness against human disease has not been scientifically proven. Typically, you will find antibodies on the market that have been produced from a clone similar to the original antibodies. Since the actual sequence of an expression clone is part of the patent of a drug, the vast majority of primary sequences are not published. Therefore, most RUO molecules – including antibodies – are produced on the basis of a sequence that is close to, but not identical to, the therapeutic molecule.
Furthermore, therapeutic molecules/antibodies are only a part of the final drug: the Active Pharmaceutical Ingredient (API). Forumulation of the buffer of a drug is another important component of therapeutic molecules and therapeutic antibodies. Therefore, all drug aliquots from Evidentic contain the API of the drug and other components that are critical for some analysis purposes.
After all, nowhere else will you find different batches of the same API.
The advantage of obtaining different batches of the same active ingredient is that these batches come from different manufacturing runs. Therefore, they have different biological and physiochemical properties: The active pharmaceutical ingredient (API) of each product run, i.e., the drug substance, may contain minute batch-specific variations that depend on a number of exogenous production conditions such as pH, cell culture medium, temperature, and endogenous factors including post-transcriptional and -translational modifications.
In particular, biosimilar developers ask for reference product batches from different (originator) production runs: obtaining a range of different production batches for a biocompatibility assay helps characterize these batch-specific differences.
Evidentic’s therapeutic molecules, reference drugs and therapeutic antibodies are obtained from reference products and biosimilars. Reference products are referred as reference medicinal products (RMP) in Europe or reference listed drugs (RLD) in the USA. A product has established itself as a reference product if it was the first therapeutic agent to be approved in the market via a new approval (IND) and if it enjoys patent protection for a number of years. These products later serve generic companies to use these original products as reference substances for comparative analytical investigations and as comparator drugs in clinical studies. Especially for the biotechnology industry and the biosimilar industry, RMPs serve as the most important reference source for the active pharmaceutical ingredient (API) contained in them.
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.
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.
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.
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.
Yes, it is! If you require it, we can send you the photos of the original filled-finished product, as we receive it.
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: firstname.lastname@example.org
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.
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.
Each batch of an original drug is purchased by a procurement specialist from qualified wholesalers or directly from the manufacturer. A continuous temperature-controlled transport process also guarantees correct storage conditions at every stage of the logistics process. Our GDP-certified storage facilities are regularly inspected by local authorities to ensure the high drug storage standards you expect from a pharmaceutical supplier. The subsequent process of manufacturing drug aliquots and diluted drug aliquots is performed by a biopharma analytical specialist with more than 20 years of experience in sample preparation for analytical analysis. All products are stored according to the original manufacturer’s conditions or at -86°C to maintain the stability of the proteins over a longer storage period. Which documentation do you provide?
We perform a GDP-compliant sourcing including all pedigree information for our clients (photos of all originally packs)
We provide an Aliquote Datasheet (ADS) with purchase date, origin (EU), transportation and storage conditions during GDP transportation/storage, aliquotation date and the storage temperature of the resulting aRMP tubes.
A Certificate of Analysis (CoA) is an official document issued by the manufacturer of the medicinal product. It contains information on some critical quality characteristics of the medicine. CoA’s are available only for some medicines and limited batches. Customers can order the medicinal product CoA together with the aliquots of the same batch. If you would like to purchase a CoA for a specific aliquot, please see the CoA product page. As Evidentic does not perform analytical tests on the drug aliquots, all CoAs available through Evidentic are from the original pharmaceutical product (RMP).
For licensed pharmaceutical products Certificates of Analysis (CoAs) are issues with each new batch that is supplied to the market. As pharmaceutical products are licensed by an international or national authority the manufacturing processes and quality + safety guidelines for each product are submitted to the authority before a marketing authorisation is granted to the manufacturer. In Europe, the EMA (European Medicines Agency) is the regulatory authority with which all EU medicines are registered. During the registration process, the applicant submits all necessary documents to assess the safety and efficacy of the manufacturing process. Detailed information on many aspects of the manufacturing, handling, storage and distribution process is kept at the Agency. The Agency assigns an EU registration number under which each product can be uniquely identified.
Once the Agency has granted the applicant manufacturing and distribution rights, all processes described to the Agency must be maintained and followed. However, the holder of the manufacturing and distribution licence (authorisation) is not obliged to provide further documentation when reselling his medicines to hospitals, wholesalers or pharmacies. This includes the certificate of analysis. The manufacturer is free to provide a CoA to the customer.
We work together with a large network of pharmaceutical suppliers. In some cases it will be possible to obtain CoAs products that you have purchased from a source other than Evidentic. However, all CoAs that Evidenic can offer for our own products will be shown on the CoA product page – in other words: what you see is what you get!
We can also advise you for which products CoAs are available in Europe and for which products this is generally not possible. Just ask us!
Once you have chosen your products and wish to place your order, you will receive a summary of your product inquiry. This summary includes product information, batch information, quantity and finally prices. In some instances, prices can only be confirmed after you get in contact with us. Finally, a quotation will be sent to your E-mail address.
Even though our therapeutic antibodies are research consumables (RUO-products), the origin is from a licensed drug. For ordering aliquots, a short client qualification process is therefore necessary. A short questionnaire needs to be filled including a non-human usage declaration, stating that the products are only for non-human, research applications.
Please note that our products are to be used only be trained personell in a laboratory environment. Evidentic will not sell products to private households.
No trading license is required for ordering since our products are classified as ‘research-use-only (RUO) consumables.
Evidentic’s product portfolio is targeted at pharmaceutical research customers, biosimilar development customers, government or other non-profit research laboratories, non-clinical research organizations or related institutions.
For regulatory purposes, we treat drug aliquots of therapeutic molecules/antibodies as true drugs. This means that Evidentic must qualify anyone who wants to order drug aliquots. This process is only required once for new customers.
Qualification to order dilutions is not required.Why is a client qualification necessary for ordering aliquots?
Evidentic is a business-to-business solution provider to the pharmaceutical industry and to non-commercial institutions. For regulatory reasons, we are obliged to qualify our customers who wish to purchase before the first transaction can be completed. Even though our drug aliquots are research consumables, they are derived from licensed drugs. For ordering drug aliquots, a short client qualification process is required. The end-user needs to complete a non-human usage declaration, stating that the products are not for non-human, but only for research applications.
This process is required only once for new customers.
Dilutions can be purchased without qualification by both commercial customers and non-commercial institutions.
The end user must complete a short questionnaire that includes a declaration of use for non-human purposes stating that the products are intended only for non-human research applications (RUO) and may not be transferred to third parties. The address provided on the questionnaire must match the shipping address of the products. If the shipping and billing addresses are different, both addresses must be qualified.
Dilutions may be purchased by both commercial customers and non-commercial entities without qualification.
The qualification process mostly depends on the responsiveness of our customers. On our side, the process would take on average less than a business day, once we received the blue-ink signed and stamped version of our qualification document. DocuSign’ed verification is also acceptable.
Regularly speaking, dulited drug aliquots are not considered as pharmaceuticals anymore, but research consumables. That’s why we don’t need any qualification documents from our clients for diluted drug aliquots.
The mode of transportation of drug aliquots may differ between clients, typically depending on factors such as temperature range, or geographical location. For standard transport solutions (typically FedEx) you can see the pricing to your location in our online shop during the check out.
Additionally, we may charge services fees for oversees clients (export declaration, certificate of origin (CoO), EUR1 documents). Import taxes may apply in your country that may be charged separately by the carrier during importation (all non-EU clients).
Evidentic can take care of the whole transport organization, proposing different shipment temperatures, temperature monitoring record, as well as the export procedures to your laboratory, if it is located outside of the European Union.
Yes, we do! A temperature logger device is added to each GDP-compliant shipping box, so that customers have a PDF-read-out of each single transport event.
Other clients operate with contracted logistic partners to pick up medical or analytical supplies from any location worldwide. In this case no logistic service is required.
In some cases, clients require a cold shipment including cooling elements along with certified shipping containers, classified as a non-GDP compliant shipment.
Yes, it is! The order fulfilment includes special shipment requests for all customers. In the pharmaceutical industry shipments, according to good-distribution-practice (GDP) may be preferable or even considered standard. For a GDP-compliant logistic service, we use GDP-certified third-party logistic partners, guaranteeing end-to-end temperature-controlled shipments in certified shipping containers at constant temperatures for up to 96 hours.
As majority of our products classify as ‘cold-chain products’, we generally ship all our products either at -70°C or 2-8°C, unless otherwise noted in the storage conditions. Even if special shipment conditions can also be arranged, most of our customers choose to shipment at -70°C, without seeing any effect over the product’s activity.