In the field of Biologics, IDT Biologika focusses on the manufacturing of sterile, injectable large molecule products, including packaging. We offer services from clinical phase II/III to the large scale commercial manufacturing of vials, pre-filled syringes with and without safety device, the auto injector assembling as well as several packaging formats. Our manufacturing platforms provide GMP compliant end-to-end services in BSL2 facilites meeting EMA, FDA and ANVISA standards.
Formulation Development
Process Transfer
Process characterization and Validation
Filling
Lyophilization
Visual Inspection
Packaging
Storage
Development of Client Specific Methods
Method Transfer
Method Implementation
Method Validation (ICH)
Release Tests
Stability Studies
Preparation of CMC Documents