Manufacturing authorization and GMP certificate for antibody production at Fraunhofer IZI

12.7.2018

On July 12, 2018, the Landesdirektion Sachsen (Saxony Land authorities) certified a further GMP clean room facility at the Fraunhofer Institute for Cell Therapy and Immunology IZI, expanding the facilities already available in the Main Department of GMP Cell and Gene Therapy. This marks the first time the Department of Therapy Validation’s Antibody Production Unit has been awarded GMP certification or authorization in accordance with Section 13 of the German Medicinal Products Act (AMG) to manufacture a therapeutic antibody as an investigational medicinal product.

The procedure involved a comprehensive four-day inspection, which was conducted by the competent federal and state authorities from April 16 - 19, 2018. A seven-strong core team at Fraunhofer IZI responsible for manufacturing, quality control and quality assurance showed the inspectors around the facility and demonstrated all the GMP processes comprehensively and convincingly, furnishing proof of how all the regulatory requirements laid down in the EU's GMP guidelines had been met.

Once construction was completed on the biopharmaceutical GMP clean room facility for antibody research back in April 2015, the clean rooms and equipment were then qualified and initial SOPs and other GMP-related documents prepared. Following this, the pilot process for obtaining manufacturing authorization was planned and initiated in accordance with Section 13 of the German Medicinal Products Act.

Thanks to its flexibility (e.g. through the utilization of single-use materials) the new GMP clean room facility can be used for all kinds of projects as well as for process validation or equipment qualification purposes. The ability to develop and optimize customer-specific processes with an eye to time and cost efficiency is one of Fraunhofer IZI’s strengths here.