Biopharmaceuticals

Production of a monoclonal antibody for therapeutic use for the prevention of Graft-versus-Host-Disease (GvHD)

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)