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Good Manufacturing Practice

To transfer products developed by research groups at the BCRT into the clinical setting a manufacturing facility that meets the standards of Good Manufacturing Practice (GMP) is required. Our Multiuser Unit GMP provides the BCRT with an autonomous GMP production facility for advanced therapy medicinal products (ATMPs) where somatic cell therapy products, tissue products and gene therapy products for clinical trial samples can be produced. The center operates a 140-square-meter state-of-the-art cleanroom facility for this purpose. An additional 260 square meters of lab space is dedicated to quality control and storage, including cryostorage for released and non-released (quarantined) finished products. A quality management system is in place to translate processes from the development stage through to GMP-conform production.

Research Focus

Currently, the BCRT is licensed to manufacture two cell products: CMV- and EBV-specific T cells.

A process for manufacturing natural regulatory T cells is currently under development.

Service

  • GMP Development
  • Product Translation
  • Training
  • QM System

Equipment

  • Cleanroom
  • Flow cytometer/NAVIOS
  • Cryostorage (approval)

Team

Prof. Dr. Petra Reinke
Qualified Person

Dr. Sybille Landwehr
Pharmacovigilance Commissioner

Dr. rer. nat. Andy Römhild
Head of Manufacturing

Daniel Kaiser
Head of Quality Control

Carola Beier
Deputy Head of Manufacturing

Henrike Führer
Deputy Head of Quality Control

Anne Forke
Manufacturing Area

Insa Lehmann
Quality Control Area