On 10 January 2014, the existing manufacturing authorization according to Art. 13 of the German Drug Act (AMG) of the Fraunhofer Institute for Cell Therapy and Immunology IZI was expanded to cover the first extension of the existing cleanroom facility.
After extensive qualification and inspection by the Regional Council of Saxony, the »Certificate of GMP-Compliance of a Manufacturer« was also updated. This seal of approval doubles the institute's capacities to manufacture cell-based medicinal products, or so-called »Advanced Therapy Medicinal Products« (ATMP).
Cell therapy products for clinical studies can now be produced on a total cleanroom area of over 750 m² in sixteen cleanroom class B manufacturing rooms to be operated independently.
The specific facility design allows for the parallel manufacture of several cell therapy products without the risk of mutual cross-contamination.
A separate part of the facility is furthermore specifically designed for the manufacture of products that must meet special safety requirements with respect to genetic engineering or protection against infection.
The operation of two separate and independent facilities provides maximum flexibility and continuity in the manufacturing processes, especially for bridging regularly scheduled maintenance periods.
A major part of the new facility is already booked out with manufacturing projects for various different clinical studies up to Phase III.
The staff consisting of 61 qualified employees currently handles both GMP facilities, the associated projects and the comprehensive quality assurance system. These professionals have profound expertise in the production and quality control of autologous and allogeneic cell therapy products, process development, and the validation of production processes as well as quality controls.
The cleanroom capacities of the Fraunhofer IZI shall again be expanded with a third construction section by mid-2015 to meet the continuously growing demand in this business sector.