Performance, biological safety and efficacy evaluation of medical products for blood purification

Fraunhofer Institute for Cell Therapy and Immunology IZI ASSESS-MED dialyzer test laboratory

Rostock, Germany

The Fraunhofer Institute for Cell Therapy and Immunology IZI researches and develops special problem solutions at the interface of medicine, biosciences and engineering. One of its main tasks is contract research for biotechnological, pharmaceutical and medical technology companies, clinics, diagnostic laboratories and research institutes. The Fraunhofer IZI develops, optimizes and validates processes, materials and products in the fields of cell and gene therapy, active substances and vaccines, molecular and immunodiagnostics and extracorporeal therapies. Its expertise lies in the fields of cell biology, immunology, drug biochemistry, bioanalytics, bioproduction, process development and automation. Research focuses on developments in the field of immuno-oncology and infection pathology. In the S3 safety laboratory, research and development work is carried out under biological protection level 3 and highly pathogenic pathogens are examined. The institute is clinically oriented and carries out quality tests and GMP-compliant production of clinical trial samples. In addition, it supports partners in process development for the pharmaceutical production of ATMPs and biologicals, including obtaining manufacturing licenses and approvals.