What are therapeutic antibodies?
Therapeutic antibodies are developed for the treatment of human diseases. They are the active ingredient of original drugs, actually prescribed to human patients for treatment of various diseases, typically cancer. They target antigens like HER2, TNF or CD20 and their therapeutic function was proven in clinical trials.
What’s the difference to other commercially available antibodies?
Therapeutic antibodies differ from diagnostic or research antibodies due to the fact that they are derived from actual drugs used for humans. This implies:
• Their therapeutic function in human was proven in clinical trials
• Their antigen-neutralizing properties or physiological down-stream effects were proven in clinical trials
• They were registered within a medical regulatory authority such as EMA
• They represent the first authorised medicinal product and serves a a reference product (RMP / RLD) for Active Pharmaceutical Ingredients (API)
Which benefits do I have from ordering at Evidentic?
For researchers, therapeutic antibodies are mostly difficult to obtain. At Evidentic you can purchase therapeutic antibodies from original EU-licensed medicines as licence-free consumable for research use. For customers requiring different batches we built up an on-stock library to offer numerous batches of the same API (active pharmaceutical ingredient). In order to increase the size of our library, we regularly inspect the market for new batches of our on-stock drugs.
Are the therapeutic antibodies approved by FDA or EMA?
Evidentic offers by now only EMA-approved therapeutic antibodies. The European Medicines Agency EMA is responsible for the scientific evaluation, supervision and safety review of medicinal products for human and veterinary use in the EU.
Which applications are allowed for therapeutic antibodies?
Still being small quantities of a finished drug, the use is for analytical research only and not for human application.
Can I get therapeutic antibodies elsewhere?
You can possibly find other antibodies on the market, but they won’t be therapeutic, which means they won’t be scientifically proven to be effective against human diseases. Typically, you can find purified antibodies on the market. Such antibodies still only represent one part on the medicine: the Active Pharmaceutical Ingredient (API). Our therapeutic antibodies contain the drug’s API and other expedients that are crucial for some analysis purposes.
Finally, you won’t find any place else where different batches of the same API are available.
What is the advantage of ordering different batches of aliquots?
The advantage of getting different batches of a same API, is that those batches come from different manufacturing runs. Thus, they will display variety in biological and physiochemical characteristics: the active pharmaceutical ingredient (API) of each product run, so the drug substance, may contain minute batch-specific variations depending on a series of exogenous production conditions such as pH, cell culture medium, temperature and endogenous factors including post-transcription and -translational modifications.
Biosimilar developers in particular ask for reference product batches from different (originator) production runs: sourcing a range of different production batches for microheterogeneity testing or biocomparability assay will help to characterize these batch-specific differences.
What are reference medicinal products (RMPs)?
Evidentic’s therapeutic antibodies are obtained from reference products. 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.
How does Evidentic prepare the aliquots and the dilutions?
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 this high-quality procedure, the therapeutic antibodies are stored at the conditions as recommended by the original manufacturer or alternatively stored at -80°C.
As for the dilutions, the same aliquots are taken as raw material. They are diluted in our GMP-certified laboratory, under sterile conditions (Laminar Flow) to a final concentration of 1,0 mg/ml. The diluent used for the dilution is a Phosphate-buffered saline (PBS) buffer pH 7.4. The samples contain no preservatives (NaN3) and no additional BSA. After dilution, all samples are stored and frozen down at -80°C.
How many milligrams of therapeutic antibodies does an aliquot or dilution contain?
For aliquots, the concentration remains unchanged from the original product, in most cases between 2-5 mg. Commonly, aliquots contain between 2 – 6mg of the original reference product which equals between 40 – 400 µl volume.
For dilution, concentration is fixed at 1 mg/mL, for a 0,1 mg quantity of therapeutic antibody.
See more on our product list
How do you source the different batches?
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. Evidentic’s specificity as a wholesaler is that we don’t buy on demand but rather stock and build this library aiming to offer numerous batches of the same API (with different expiry dates). 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.
How do you store the different batches?
After aliquotation, half of the resulting aliquots are stored according to the manufacturer’s storage conditions for the original pharmaceutical product, and the other half is stored at -80°C. As the majority of our products classify as ‘cold-chain products’, one half of each batch is stored at 2-8°C, and the other half at -80°C.
Before a batch expires, every aliquot is frozen-down to -80°C to maintain the integrity of the API.
Are the batches stored at -80°C still usable for my experiments?
For the purpose of long-term storage, we store aliquots at -80°C just before the expiry of the reference product. The storage takes place in an alarm-secured freezer, as part of GMP conditions. Thus, the effectiveness of the API is preserved, even long time after expiry of the original medication. With each of our vials, you will receive documentation indicating the precise day where the aliquot was frozen-down.
Our clients have used both 2-8°C and -80°C samples (including coming from ‘expired’ batches) for their research. The functionality of the APIs for their experiments has been shown in their experiments.
Do you have other lots, in addition to those shown on your site?
For each product we currently have between one and 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 an information to firstname.lastname@example.org
Is your given expiry date the one indicated on the original drug?
Yes, it is! If you require it, we can send you the photos of the original filled-finished product, as we receive it.
Does Evidentic perform analytical tests on the aliquots?
Our main activities are sourcing and subsequent aliqoutation 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.
How does Evidentic ensure the quality?
Each batch of an original drug is bought through a procurement specialist from qualified wholesalers or directly from the manufacturer. An end-to-end temperature-controlled transportation process further guarantees correct storage conditions at each stage during the logistics process. Our GDP-certified storage facilities are inspected by local authorities on a regular basis to ensure the high storage standards for pharmaceutical as you would expect from a pharmaceutical supplier. The subsequent process of preparing aliquots and dilutions is carried out by a biopharma analytics specialist with more than 20 years of expertise in sample preparation for analytical analysis. All products are stored according the original manufactures conditions. Some products are stored at -80°C to maintain stability of the proteins over an extended 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.
What is a Certificate of Analyis (CoA)?
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.
Why are CoAs only available for some products?
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 products 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.
Can Evidentic obtain CoAs for products which I have in my lab?
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 (LINK) 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, the origin is from a licensed drug. For ordering aliquots, a short client qualification process is 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.
Do I need a pharmaceutical trading license for ordering?
No trading license is required for ordering since our products are classified as ‘research consumables’.
Who can order?
The product portfolio of Evidentic is indented for clients in the biosimilar industry, governmental or other non-for-profit research laboratories, clinical research organizations or any related institution.
For regulatory purposes we treat aliquots of therapeutic antibodies as genuine pharmaceuticals. That means, that Evidentic has to qualify anyone who wishes to order aliquots. This process is required only once for new customers.
A qualification to order dilutions is not necessary.
Why is a client qualification necessary for ordering aliquots?
Even though our therapeutic antibodies are research consumables, they are derived from a licensed drug. For ordering aliquots, a short client qualification process is necessary. A questionnaire needs to be filled including a non-human usage declaration, stating that the products are not for non-human, but only for research applications.
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. This qualification process requires documentation that may differ between commercial and non-commercial institutions. Once the registration process completed, the procurement can commence.
This process is required only once for new customers.
Dilutions can be purchased without qualification by both commercial customers and non-commercial institutions.
Which documents do I need for the qualification process?
A short questionnaire needs to be filled including a non-human usage declaration, stating that the products are only for non-human, research applications. Address given on this questionnaire have to match with the delivery address of the products. If delivery and invoicing address are different, both of those addresses need to be qualified.
Dilutions can be purchased without qualification by both commercial customers and non-commercial institutions.
How long does the qualification process last?
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.
Why is no qualification process necessary for ordering dilutions?
Regularly speaking, dilutions are not considered as pharmaceuticals anymore, but research consumables. That’s why we don’t need any qualification documents from our clients for dilutions.
What does a transport to my location cost?
The mode of transportation of analytical RMPs may differ between clients, typically depending on factors such as temperature range, or geographical location.
How is transport facilitated to the customer?
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.
Does Evidentic arrange for GDP-compliant transport?
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.
Is an end-to-end cold-chain transport possible?
Yes, it is! The order fulfillment 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.
At which temperature range can the product be sent?
As the 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.
Can you provide temperature monitoring record for storage and transit?
Yes, we can provide temp data and storage temp record from our storehouse to your facility.