Chemical Synthesis

Lab Scale

Give us the structure of your target molecule and a comprehensive research proposal based on your request regarding time, quality  quantity and cost will be prepared. On your order  the requested experiments to identify the most promising route and to take a first look at its scope and limits are performed. The most feasible route, samples, comprehensive analytics and, as with every activity performed at Merck Eprova, a detailed report is provided.

Starting from the identified feasible route, a laboratory process is developed. Alternate conditions as well as the stability of raw materials and products are checked. Reaction conditions using statistical methods are routinely optimized. These services provide a laboratory process that is sufficiently robust to prepare the first multigram amounts of your product.

The Project Manager in charge of these services  is the same over the whole project. Therefore, only one contact person is necessary .

Kilogram Scale

Based on the master operation records, the next batch up to 1 kg under cGMP can be performed at our specially equipped laboratory. In parallel, the procedure for the preparation is continuously optimized, in order to compile the  most economical manufacturing method. Because there is no internal tech-transfer at Merck Eprova, no information or know-how is lost. Speed and quality are assured.

At this point,  not only the product is delivered but also full documentation, including release data, certificate of analysis, lists of procedures, master operation records and a detailed report.

Pilot Scale

Starting from the laboratory process, a safe and scalable process for the synthesis of large quantities can be developed. The scalability and robustness of the process is evaluated. Typically, these investigations will be performed in the new pilot plant. These "real" conditions  enable us to solve the technical issues that may arise later. Depending on your needs, a process for bulk synthesis can be provided. Products prepared in our pilot plant and a detailed report will be provided.

Based on our production zone concept, where GMP quality engineering exists  between black (equipment/service zones) and white (GMP clean production) zones, Drug Delivery Compounds's are produced in clean room controlled surroundings classified as ISO-class 8 conditions. Drug Delivery Compound  batch sizes vary up to a maximum of 100 kg. Final products are handled in white zones and closed equipment. This reduces the risk of contamination, improves safety and makes it possible  to handle sensitive products.

If  larger quantities of Drug Delivery Compounds are required,  a technology transfer can be arranged within the Merck group of companies or  to a manufacturer of your choice.