Phase II to III → Commercial


Fill & Finish of Biologics

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.

Clinical and Commercial Supply

Formulation Development
Process Transfer
Process characterization and Validation
Visual Inspection


Development of Client Specific Methods
Method Transfer
Method Implementation
Method Validation (ICH)
Release Tests
Stability Studies

Regulatory Support

Preparation of CMC Documents


Other IDT Biologika Services