With a prototype in hand, the next logical step will be to test it in a clinical trial. Whether you have a prototype and need a suitable clinical trial material manufacturer or you need clinical trial material from the final equipment to supply a Phase III study. Our R&D site, as well as the commercial manufacturing site are equipped with the required know how and the regulatory system to handle clinical trial material manufacturing, release testing and concurrent stability studies.
Our R&D site in Langenfeld can handle clinical trial material orders from 500 up to 5,000 samples per batch using either small scale or pilot scale manufacturing equipment in a class D/100,000 cleanroom area. The cleanroom works under full cGMP compliance, audited by customers and authorities. It will give you not only the chance to manufacture suitable clinical trial material up to Phase II clinical studies but will also give you the opportunity to assess general process ability of your prototype without the costs of a large scale batch by using what we call our LabFactory. This pilot scale manufacturing equipment is based on the same manufacturing principles as the large scale manufacturing equipment at our production site.
The production site located in Hamburg is able to provide late stage clinical trial material from final manufacturing equipment using the full potential of our commercial cGMP compliant supply chain.