It’s our focus to develop the production of novel drug delivery compounds in close collaboration with our customers. To add value to your business and reduce project-related regulatory risks we work in close contact with our customers and offer tailored approaches according to the project’s requirements. We offer our long-standing experience in the development and scale-up of proprietary DDCs ranging from pre-clinical evaluations to large scale commercial quantities.
On a Lab Scale
Based on the structure of a customer’s desired compound we will establish a comprehensive proposal including cost, timelines, quality and quantity. By request, we will suggest various synthesis routes and recommend a strategy to move forward. An initial feasibility study will be concluded by delivering material samples , comprehensive analytics and a detailed report summarizing our work.
In the following step, we optimize reaction conditions to develop a robust lab scale process and analyze the stability of the product. At this time the synthesis process will be sufficiently robust to prepare the first multi-gram quantities.
The entire lab scale development is supervised by a single research project leader, which facilitates communication to our customers and accelerates the development process.
On a Kilogram Scale
Coming from the master operation records, a batch of up to 1 kg will be synthesized in our labs equipped for cGMP operations. The preparation protocol will be constantly optimized and there is no requirements for internal tech-transfers since all procedures are carried out at the same MilliporeSigma site in Schaffhausen. This eliminates the loss of know-how and assures speed, accuracy and quality.
We conclude the production on a kilogram scale by providing the synthesized product together with a comprehensive documentation file including release data, certificate of analysis, lists of procedures, master operation records and a detailed summarizing report.
On a Pilot Scale
The established laboratory protocol allows us to develop a safe and scalable process to synthesize quantities larger than one kilogram. These procedures will be performed in a pilot plant, allowing us to anticipate technical issues and provide a process for bulk synthesis. Products prepared in pilot plant and a detailed report will be provided to our customer.
Our cGMP production plant is divided into black (equipment/service zones) and white (GMP clean production) zones. All Drug Delivery Compounds from MilliporeSigma are produced in clean rooms classified as ISO-class 8. We provide batch sizes of up to 100 kg where the final product is exclusively processed in white zones and closed equipment. These procedures almost eliminate the risk of contamination and improve the overall safety profile for sensitive products.
DDC quantities of over 100 kg can be provided after an internal technology transfer to other production sites within the MilliporeSigma group.