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.
Process Development, Design and Characterization
Analytical Development
Drug Substance Manufacturing
Formulation Development
Filling
Lyophilization
Visual inspection
Packaging
Process and Analytical transfer
Process Validation
Drug Substance Manufacturing
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
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.
