We support both clinical and commercial manufacturing with in-house analytical and microbiological services as well as stability studies.
Our internal laboratory capabilities cover all standard methods and are supported by a network of qualified external laboratories for specialized or non-routine analyses.
For biomolecules, we collaborate with local GMP-certified analytical partners with whom we continuously develop project-specific expertise.
Monitoring cultivations and isolate identification
Bioburden, microbial contamination
LAL Tests (gel-clot & turbidimetric methods)
Microbial identification
We support our manufacturing services by complete stability program which includes ICH, photostability, Zone IV, infusion, in-use and transportation studies.
Available storage conditions and capacities:
2 – 8 °C: 1,500 liters (flexible capacity can be added)
25 ± 2 °C / 60 ± 5% RH: 5,000 liters
30 ± 2 °C / 65 ± 5% RH: 5,000 liters
30 ± 2 °C / 75 ± 5% RH: 880 liters
40 ± 2 °C / 75 ± 5% RH: 450 liters
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Services
Development
Formulation development, lyophilization cycle design and related studies are conducted by qualified external partners with proven experience in the transfer of process parameters to production scale.
Efficient technology transfer is essential for a successful transition from development to commercial manufacturing. Our structured approach is based on collaboration, clear responsibilities and transparent communication.
We provide aseptic Fill & Finish services for global markets from our two EU-based facilities. Drawing on long-standing expertise in commercial manufacturing, we ensure the reliable supply of sterile products worldwide.