Viral Vaccines

Development → Phase I to III → Commercial


From development through clinical phases I-III to full commercial production of viral vaccines in vials and pre-filled syringes

IDT Biologika provides GMP compliant end-to-end services in BSL2 facilites meeting EMA, FDA and ANVISA standards. Our process development and cGMP clinical manufacturing capabilities and our experience with multiple technology platforms provide a comprehensive foundation for developing processes for live and attenuated vaccine candidates emerging from the research lab, for advancing through clinical development to commercial production.

Preclinical and Clinical Supply

Process Development, Design and Characterization
Analytical Development
Drug Substance Manufacturing
Formulation Development
Visual inspection

Commercial Supply

Process and Analytical transfer
Process Validation
Drug Substance Manufacturing
Visual Inspection


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

Regulatory Support

Preparation of CMC Documents

IDT Biologika offers viral vaccine manufacturing from bulk drug substance to sterile filling including formulation, analytics and efficient packaging. The competencies and capabilities reach from early development delivering test samples in small volumes to validation and large-scale industrial vaccine production.

Many human vaccines developed by IDT Biologika, together with international partners, are already in use, fighting infectious diseases such as tuberculosis, AIDS, malaria, cancer, dengue and Ebola.


Other IDT Biologika Services