Manufacturing
Our technical experts are involved right from the start of your project and remain involved during process transfer and production. We ensure a smooth transition from the project’s early phase up to commercial scale.
Our expertise in both development and manufacturing, together with advanced technological capabilities and innovative approaches will overcome development hurdles and help you to speed your products to market, no matter what challenges may arise.
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)