R&D Center for Drug Delivery Compounds
Schaffhausen, Switzerland
The Merck 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, PEG-hydrogels, 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