GMP-compliant production area
We offer an 800 square meter multi-purpose manufacturing area with graded pressure zones in separate facilities. In our modular class C and D cleanrooms, new devices and technologies can be flexibly implemented according to your needs. Our production areas are equipped with:
- Constant environmental monitoring for temperature, humidity, pressure, particles and microbiological safety
- 7 isolators with hermetically sealed individual workstations (class A-in-C)
- Hydrogen peroxide disinfection with fixed piping
- CO2 tissue culture incubators
- Liquid nitrogen cryopreservation storage
- Electronic batch record reports
- Dedicated set-up for cell culture and cell-based therapeutic production in accordance with GMP guidelines and FDA requirements
Modern infrastructure: Our research laboratories
Our laboratory infrastructure is equipped with modern instrumentation and allows us to carry out and establish a wide range of analytical methods for the quantitative and qualitative characterization of cells, biomaterials and ATMPs. Our equipment includes (e.g.):
- (RT-)PCR
- HPLC
- ELISA
- Fluorescence microscopy
- Flow cytometry
- Lyophilization
- Cryotomy
Highest level of quality control
Our quality control laboratories can design and perform a wide range of analytical methods for cell therapies and ATMPs in-house:
- Cell characterisation and phenotyping
- Cell yield and viability analysis
- Automated RNA isolation and cDNA synthesis, RT-qPCR
- Sterility testing (BacT/ALERT® system)
- Standardized mycoplasma detection
- Endotoxin determination
We also offer serological testing through an established contract laboratory. If your project requires more specialized chemical analyses, rheological or mechanical strenght testing, our long-standing partners con provide services tailored to your needs.
Your contact person for our CDMO services
Do you have questions about our CDMO services, or would you like to learn more about our portfolio? Our CDMO experts will be happy to help. We look forward to meeting your CDMO needs.