The aim of the project is the GMP-compliant production of a monoclonal antibody for the clinical trial for the prevention of Graft-versus-Host-Disease (GvHD) in allogeneic stem cell transplantation.
The project includes the following work packages:
- Production of the master cell bank, its characterization and quality control
- Process development of the upstream and downstream process
- Formulation Development
- Production of GMP-compliant batches for the preclinical and clinical trial
- Establishment and validation of the approval-relevant analysis for quality control including in-process controls, as well as structural analyses and stability investigations including stress tests and long-term investigations
- Contribution to the Investigational Medicinal Product Dossier (IMPD)