Biopharmaceuticals

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)