Contract Manufacturing


You have selected an interesting molecule and now you are in need of mg, g or even kg quantities for further testing or for usage in clinical trials or as a payload produced under GMP conditions?

 

We work with partners around the world who offer exactly the services needed. The production facilities are equipped for handling Category 4 (OEL classification 1 – 0.05 μg / m3).

 

In case of technical questions, you are of course in direct contact with the manufacturer. The challenge of producing Actinomycin X2 is a good example to showcase our services. Our client was searching on the market for this product for months and used his network intensively but without success. Finally, they approached Cfm and were not confident that they might have a chance to proceed with their project. Our team thought that with some emails, phone calls and perhaps some screening Actinomycin X2 would be found and able to deliver to the customer. But this one not – not at all. The product was not available in Europe, USA, Japan, Australia/New Zealand or China. So to be able to have a chance to get this product we had to search for the strain. After two years of intensive market investigations, the team of Cfm together with cooperation partners found the strain which produces Actinomycin X2 in a research laboratory in Berlin. Subsequently, this strain was cultured in the laboratory of our manufacturing partner. It could have been simple if the fermentation just would produce the product – but you can imagine the challenge was not offer so far. The fermentation alone was extremely challenging, as the strain poisoned itself. Again further development was necessary to be able to reach our target – only some grams of Actinomycin X2. As time is a critical parameter our partners optimized the harvesting time and were able to harvest good crude material. What else than an extremely difficult purification followed which was finally successfully. In the end, thanks to the help of our partner, we were able to deliver the product to our customers with a purity of> 90%. After reviewing this project of producing Actinomycin X2 we were only able to realize this due to an extreme good team work among specialists on all sides – customer, cooperation partner and Cfm.

ADCs Production

Payload Sourcing


Payload Sourcing

The product category Payloads contains a variety of substances that are very new. In addition, well-known or forgotten products with possible applications in the field of ADCs are listed as well. In our regularly updated “Cytotoxins – Warheads” product list, now already the 15th edition, you will also receive them in print-version.

If, contrary to expectations, you do not find the product you are looking for in our list, we will gladly help you find a suitable manufacturer.

Through our worldwide network of research institutions in various disciplines (fermentation, extraction, and chemical-synthesis), universities, specialized laboratories or specialized GMP manufacturers, we can usually deliver the product we are looking for, should there be no customs, regulatory or legal barriers avoiding us deliver.By participating regularly in fairs, congresses, symposia and exhibitions, we are always up-to-date with the latest trends in this area. Not only personally, we are also there for you online. On our Cfm-Linked-In-Focus page for ADCs you will find interesting articles about new products and trends.Have stimulated your interest? Just get in contact with us to discuss further details.

Payload Linker Conjugation


If you already have selected a cytotoxin, ideas for a corresponding linker and you are looking for a suitable manufacturing partner for the so-called payload-linker conjugation, we can of course also help you in this case. On basis of already implemented projects, we have gained experience in this area. Depending on the scope of your project, experienced production partners in Europe or even in North America are available. These can accompany your project from early research to clinical trials through to the final cGMP production process.Our sister companies, Iris-Biotech GmbH and Iris-Biotech Laboratories are global specialists in peptide-based linker technologies. We assist you in selecting or producing the appropriate linker. You, or your lawyers, only have to help us with the patent law questionnaire. We take care of the production.Nearly all possible common linker variations were already produced successfully in high purity for test purposes. From Boc-Val-Ala-PAB via Fmoc-Val-Ala-PAB to Mal-Dap (Boc) -Val-Ala-PAB-PNP. If you require a different linker technology, contact us.

Payload Linker Konjugation

Logistics Services for HPAPIs


Logistikdienstleistungen für HPAPIs

Not only the production of these highly potent substances requires very special equipment, experienced chemists and all conceivable safety precautions. The subsequent logistics is more than a normal challenge and this seemingly trivial activity can decide whether your project is a success or a failure.In addition to suitable outer packaging, mostly so-called UN-V boxes, special inner packaging, the choice of the suitable mode of transport, has to comply with all the other important regulations. Depending on the substance class, certain documents may be required prior to shipping.These can range from a simple end-user declaration for shipping within Europe to an export license for shipment to a third country. The authorization alone can take over a period of up to six weeks. Furthermore, special transport-relevant documents (shippers- declaration for airfreight shipping) or country-specific requirements such as a TSCA certificate can be mentioned. As far as possible, we take care of all these complex tasks as part of our service.Focus on your project and leave the rest to us!

Marketing of Payload Candidates


Our services are not a one-way street. If you have an innovative payload with the latest possible “Mode of Action”, but have no market knowledge or limited marketing experience, we can help you here as well.

At the beginning of such a process we start with the signature of CDAs (Confidentiality Agreements) or NDAs (Non Disclosure Agreements), followed by the signing of an MTA (Material Transfer Agreement). All these documents are required to be secure and give you the assurance that you are determining what happens to your molecule and what does not.

We can already record success in this area as well. University partners with groundbreaking new product candidates entrust us their hopefully future blockbuster molecules to make them known on the market. The multitude of potential product candidates also includes the right networking, trust in the market and our experience in this area.

If you are in possession of such a molecule, please do not hesitate to contact us. We are happy to evaluate the chances in a confidential first meeting and give you useful tips if necessary.

Cfm Handschlag

Network Service for ADCs


Netzwerkservice für ADCs

In addition to all these mentioned services, we offer further support for your projects.

Examples include the analytical support. Specifically, the ADC field demands the latest, state-of-the-art analytical methods and analytical equipment with equally skilled personnel. All this we can be offer through our partners.

Furthermore, we have contacts to certified and reliable laboratories for in vivo pharmacology, bioanalysis, molecular biology and chemical studies. In addition, we also offer bio-distribution studies including in vivo bio-imaging, LC-Radio Monitor-MS, LC-MS. Together with us and our partners, your projects are in good hands.

We have the appropriate answer for nearly every question. Our motto “FINDING THE BEST SOLUTION FOR YOU – 2Gether ONE STEP AHEAD” is our quality promise to you!

Innovationen for a
better world

We supply the keys to new therapies

Antibody Drug Conjugates (ADCs) are a new approach in the development of innovative drugs for cancer therapy. This fundamental technology has already been described in 1908 by Paul Ehrlich and awarded with the Nobel Prize in Medicine. Human antibodies are coupled to highly potent toxins (conjugation) to selectively kill cancer

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