Manufacturing
Our drug substance manufacturing in state-of-the-art cGMP facilities meets the highest standards of the biopharmaceutical industry. Each manufacturing process is scalable for different requirements - for clinical trials as well as for market supply.
Cell Culture / Upstream Processing
We work in our state-of-the-art cGMP facilities with highly qualified personnel and manufacture biopharmaceuticals for clinical studies and market supply.
Our Expertise
- Clinical and commercial drug substance manufacturing
- Manufacturing in stainless steel and single-use bioreactors
- Cultivation methods: Fed-batch, continuous and perfusion mode
- Cell banking: Production, testing and storage of master and working cell banks
Manufacturing Capacities
- Flexible multi-product plants for upstream and downstream processes
- Single-use bioreactors up to 2,000 L and stainless steel bioreactors up to 3,000 L
- Continuous capacity expansion at all locations to meet the growing demand of our clients
Your Benefits
- Customized and cost-effective manufacturing
- Our experience with a wide variety of recombinant proteins and innovative formats
- Best-fit production set-up addressing agility of client projects
- cGMP production for clinical and commercial supply
- High degree of flexibility enabled by multi-product facilities
- Wide variety of bioreactor scales and technologies
- Multiple seed train and upscale options
- Fed-batch and continuous processes
- In-house manufacturing support services
Purification / Downstream Processing
The purification of proteins from cell culture supernatant is a crucial step in the production of drug substance. We specialize in the bioprocess development of therapeutic proteins such as monoclonal antibodies and fusion proteins. Therefore, we can reliably reproduce the efficiency and robustness of the process steps for your active ingredient.
Our Expertise
- Chromatographic separation including anion/cation exchange, affinity, hydrophobe interaction
- Filtration and extraction
- Virus inactivation and removal
- Protein modification
Your Benefits
- High quality and fastest possible time-to-market
- Our know-how in protein purification
- Our experience with a wide variety of technologies
- In-house manufacturing support services
Quality Control
Our drug substance manufacturing in state-of-the-art cGMP facilities meets the highest standards of the biopharmaceutical industry. To guarantee this, we follow high-quality standards within our internal processes and our team. Comprehensive quality management and precise, as well as reliable quality control, ensure excellent performance and results. We pay attention to the continuous monitoring and the adaptation of our quality standards.
Our Expertise
- Comprehensive monitoring of all parameters for quality control
- Analytical characterization of biopharmaceuticals
- Drug product/drug substance release testing
- Comparability and stability studies
- Development and qualification of standard and product-specific methods
- State-of-the-art methods and equipment, e.g. capillary isoelectric focusing, CE-SDS, mass spectrometry, surface plasmon resonance spectrometry
Your Benefits
- Ensuring purity, safety and stability of your product
- Convenience of an analytical full-service
- Extensive experience in biopharmaceutical analytics
- Our know-how in stability testing
