The MilliporeSigma R&D Center of Excellence in Schaffhausen, Switzerland has been successful in the market since 1952, providing customers with process development, and scale-up of proprietary drug delivery compounds (DDCs) in a tailored approach according to the project’s requirements.
Expanded in 2009, our R&D Center of Excellence now provides DDCs out of state-of-the-art cGMP facilities for use in clinical trials and commercial product applications. With over 50 years of experience, we pride ourselves on transforming R&D substances into commercial products.
Our team of dedicated scientists not only helps develop innovative products, but also provide the highest level of development expertise and support for our activated PEGs
, specialty lipids and parenteral applications. Our position as a large European manufacturer allows us to offer a full spectrum of services from reaction screening to commercial supply and beyond. Services
- Manufacturing process design of new DDCs
- Scale-up of production processes and technology transfer to other sites
- Support for regulatory documentation and patent submissions
- Process validation and commercial manufacturing
- Analytical method development for a broad range of methods and validation
- Synthesis and characterization of impurities and reference standards
- Chemistry and engineering know how to create efficient and robust processes
- cGMP facilities that comply to highest regulatory standards for parenteral applications (lipids, activated PEGs and APIs)
- Crystallization know how of lipids for improved stability and easier handling
- Activation chemistries for PEGs from grams to multiple kilograms
- Separation and purification technologies
- Sophisticated analytical equipment including 500 MHz NMR, LC-MS, ELSDS, GPC, xRay and own microbiology lab