Our Proven GMP Manufacture Is All About Your Success: The Key to Quality, Safety and Consistency
Since 2002, clients from the United States, Europe and all over the world have trusted our Good Manufacturing Practice (GMP) to produce their antibodies and recombinant proteins for clinical use. Our goal is to grow with clients towards commercial manufacturing. Working in a competitive time-frame, we are committed to nothing less than your success. The long-standing experience of our expert team assures fast and reliable conversion of all development protocols into GMP-stage and the safe manufacturing of single or multiple batches. We offer our services both in-house and for externally developed processes. Your protein deserves the best platform in order to reach its full potential – we make sure it gets just that.
Our sophisticated chemically defined media platform is the key for an efficient, easily up-scalable upstream process. We use fed batch processes in 250L and 1.000L disposable bioreactors depending on the required amounts of clinical material. All steps of the process are under the control of a comprehensive and audited quality management system. An internal Qualified Person (QP) is responsible for releasing the drug substance. We can assist the process transfer, including analytical methods.
- Fully disposable up- and downstream processes (limited risk of cross contamination)
- Own chemically defined media platform
- Platform production processes for mAbs
- Capabilities for developing and validating complex bioassays
- Flexibility for early material supply from clone pools
- Competitive timelines
- Transparency and responsiveness (extended workbench concept)
- Regulatory support
- Outstanding customer service