Gene and Immunotherapeutics

Development → Phase I to III → Commercial

 

Oncolytic Viruses, Gene and Immotherapeutics development through to commercial manufacturing

Rising interest in oncolytic viruses as well as gene and immunotherapeutics for fighting cancer, metabolic, neurological and other genetically defined diseases leads to an increasing demand for special CDMO capabilites. Our almost 100-year tradition in development and manufacturing of vaccines and biopharmaceuticals and our particular expertise with live agents and proteins motivates and obliges us to reinforce our process development and integral manufacturing services in the fields of drug substance, drug product and packaging of oncolytic viruses and viral vectors for clinical phases to commercial supply.

Preclinical and Clinical Supply

Process Development and Design
Process Characterization
Drug Substance Manufacturing
Formulation Development
Filling
Lyophilization
Packaging

Commercial Supply

Process Transfer
Process Validation
Drug Substance Manufacturing
Filling
Lyophilization
Visual Inspection
Packaging
Storage

Analytics

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

Regulatory Support

Preparation of CMC Documents

IDT Biologika's extensive know how in different manufacturing platforms and the large and small scale commercial BSL 2 manufacturing facilities meeting FDA standards make IDT Biologika an attractive partner for contract manufacturing.

 

Other IDT Biologika Services