Manufacturing
Our technical experts are involved right from the start of your project. They remain engaged during technology, process transfer and production. We ensure a smooth transition from the project’s early phase up to commercial scale.
Our knowledge of developing cell lines, how to develop processes and make products, and our use of advanced technology and new ways of thinking, will help you overcome any problems you have in developing your product and get it to market more quickly, no matter what challenges you have.
Our offer includes:
- non-GMP manufacturing of reference and pre-clinical material up to gram scale as bulk
- quality control with certificate of analysis per lot and optional molecular characterization and stability data package
- transfer of analytical methods
- transfer of documentation
- professional project management
Manufacturing using:
- 15 L stainless steel fermentation unit
- Bowl centrifuge
- Flow-through cell disintegrators (homogenizer and bead mill)
- Äkta Pilot MPLC (process scale columns up to 3 L volume)
- Sartorius TFF (up to 1.5 m² filtration area)