End-to-End Pharma CDMO

A family-owned German Contract Development and Manufacturing Organization (CDMO) providing end-to-end services for sterile drug products, from clinical development through commercial GMP manufacturing. The company's state-of-the-art facility is among the first European CDMOs to be inspected and approved under the new EU GMP Annex 1 requirements.
Its integrated service offering includes method and process development, in-house analytical services, aseptic fill-finish, visual inspection with Container Closure Integrity Testing (CCIT), secondary packaging with serialization, as well as GMP storage and GDP-compliant transportation.
The facility is designed to process a wide range of ready-to-use primary packaging formats, including prefilled syringes (up to 10 mL), vials (up to 100 mL), and cartridges (up to 10 mL), in both glass and polymer materials.
The site supports aseptic fill-finish for biopharmaceuticals, biosimilars, small molecules, and diluents such as Water for Injection (WFI), with manufacturing capabilities for batch sizes of up to 600 L.
For high-value products, the facility employs advanced fill-finish technologies designed to minimize product loss, supporting specialized manufacturing campaigns with batch sizes of up to 100 L.