Manufacturing
Our technical experts are involved right from the start of your project and remain engaged during process transfer and production. We ensure a smooth transition from the project’s early phase up to commercial scale.
Our expertise in development and manufacturing, combined with advanced technology and innovative approaches, will help you overcome development obstacles and accelerate your product’s time to market, regardless of any challenges that 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)