Frequently Asked Questions

Clinical-grade molecules

Clinical-grade molecules are molecules that have been produced with clinical quality. The term Therapeutic means that the molecule had its efficacy and safety proved to the treatment of human diseases (through clinical trials). These molecules are the active ingredient of original drugs, prescribed to human patients for treatment of various diseases. The molecules commercialised by us have these two attributes: they are clinical-grade and therapeutic.
They differ from research-grade molecules because they are derived from actual drugs approved for humans. 
For research purposes, clinical-grade molecules such as antibodies are usually difficult to obtain. From us you can purchase clinical-grade antibodies and other biologics from original EU-licensed drugs as royalty-free research consumables (RUO-only). For customers who require different batches (from different manufacturing runs), 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 search the market for new batches of our in-stock drugs.
Evidentic only offers EMA-approved therapeutic molecules. EMA is responsible for the scientific evaluation, supervision, and safety review of medicines for human and veterinary use in the EU. *EMA (European Medicines Agency), FDA (Food and Drug Administration)

Evidentic’s drug aliquots can be used for analytical, in vitro and in vivo research, typically executed in early drug development stage of drug discovery programs.

As examples we can mentioned:

  • Use as reference molecules for your assays
  • In functional in-vitro and in-vivo assays
  • For analytical procedures
  • For biosimilar and new drug early development
  • To compare against your research-grade molecules
Typically, you will find antibodies on the market that have been produced from a clone similar to the original product. Since the actual sequence of an expression clone is part of the patent of a drug, most primary sequences are not published. Therefore, most research-grade molecules – including antibodies – are produced based on a sequence that is close to, but not identical to the therapeutic molecule. Furthermore, clinical-grade molecules are only a part of the final drug: the Active Pharmaceutical Ingredient (API). Formulation of the drug’s buffer is another important component of these molecules. Therefore, all drug aliquots from Evidentic contain the original formulation of the original drug (API and buffer of the original drug, in original concentration).
The advantage of obtaining different batches of the same reference product is that these batches come from different manufacturing runs. Therefore, they have slightly 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 several exogenous production conditions such as pH, cell culture medium, temperature, and endogenous factors including post-transcriptional and translational modifications.
In particular, biosimilar developers usually require different batches of the reference product from different manufacturing runs: obtaining a range of different production batches for biocomparability assays helps characterize these batch-specific differences. You know that is virtually impossible to source different batches of the same reference product at the same time using the regular sourcing channels.
Reference products are called 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 – Investigational New Drug) and if it has patent protection for a number of years. For biotechnology and biosimilar industry, RMPs are the reference source for the active pharmaceutical ingredient (API) contained in them.

Technical

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.

After aliquoting, the tubes, that have been individually labelled, are immediately stored at -80°C.

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).
Yes, it is! If you require proof of the original therapeutic date for quality purposes, we can send you images of the original filled-finished product, as we receive it.
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: info@evidentic.com. 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 info@evidentic.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/.

Quality

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 is performed by a biopharma analytical specialist with more than 20 years of experience in sample preparation for analytical analysis. All products are stored at -80°C to maintain the stability of the proteins over a longer storage period.
We perform a GDP-compliant sourcing including all pedigree information for our clients (photos of all originally packaging are available upon request). We provide an Aliquot Data Sheet (ADS) which includes the purchase date, origin (EU), transportation and storage conditions during GDP transportation/storage, aliquotation date and the storage temperature of the resulting aliquots. Please check here an example of the ADS under www.evidentic.com/downloads/, Evidentic business information, Example Aliquot Data Sheet (ADS).
A Certificate of Analysis (CoA) is an official document from the original pharmaceutical product (RMP), issued by the manufacturer of the medicinal product. It contains information on some critical quality characteristics of the medicine. CoAs 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 download the list of the available products with CoA Drug Aliquots with CoA – Pricelist. 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 the Certificates of Analysis (CoA) are issued with each new batch that is supplied to the market. But this is not compulsory for all products and markets that is why they are not always available. All pharmaceutical products are licensed by an international or national authority, the manufacturing processes, quality and safety guidelines for each product are always submitted to the authority before the marketing authorisation is granted to the manufacturer. In Europe, 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 EMA that then assigns an EU registration number under which each product can be uniquely identified. Once the authority agency has granted the applicant the manufacturing and distribution rights, all processes described to them 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.
Unfortunately the probability of obtaining CoAs for products that we do not trade is very low. But you can always buy retrospectively the CoAs of the products that you have bought already from us (in case they are available) or just the CoAs without the need of buying the aliquot as well.

Ordering

Once you have browsed through or portfolio of clinical-grade molecules as aliquots, you have two ordering options: You can send us an inquiry to info@evidentic.com with the products that you are interested in and we will then receive an offer from us or you can buy directly online through our web shop. Even though our clinical-grade are research consumables (RUO-products), their 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, analytical and in vitro and in vivo applications. This qualification is valid for 2 years and needs to be renewed using a very simple requalification form. You can download the forms, that can be found under www.evidentic.com/downloads/ in the ‘For new customers’ section or if you prefer, we will send them to you by email. Please note that our products are to be used only be trained personnel 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 companies, biosimilar development organisations, government or other non-profit research laboratories, academia, non-clinical research organizations or related institutions.   For regulatory purposes, we treat drug aliquots of therapeutic molecules as true drugs. This means that Evidentic must qualify anyone who wants to order drug aliquots (as already referred on the first question of the section). This process is only required once for new customers. 
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. 
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. 
The qualification process mostly depends on the responsiveness of our customers. From 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. 

Logistics

The system used for the transportation of drug aliquots may differ between clients, typically depending on factors such as temperature range, or geographical location. For standard transport solutions (2-8 °C, typically FedEx) you can see the pricing to your location in our online shop during the checkout process.  If you require that the aliquots are delivered in dry ice (at -80 °C), this is calculated in a case by case by the courier (for this option we usually use World Courier). Thera also some other additional costa that may apply. These additional costs will depend on the value of the order as well as the delivery address and they may include handling fee, export declaration, box, temperature logger when required and the special box to transport the aliquots. 

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. We can also use your own courier account (if it is one of the companies that we usually use) or even pick up the aliquots at our facilities if you prefer.

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.  The addition of a temperature logger as an additional cost.

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 -80°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 -80°C, without seeing any effect over the product’s activity. 

Evidentic GmbH
Am Mühlenberg 10

14476 Potsdam | Germany

+49 (0) 30 959 99 8831
info@evidentic.com

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