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.