for : orgenesis ltd. 70 denya street haifa, israel, 34980 from : markus schandar fraunhofer igb, nobelstraße 12 70569 stuttgart stuttgart, 08. november 2012 fraunhofer igb 1 work package offer the fraunhofer igb has a strong background to develop manufacturing processes for advanced medicinal therapy products ( atmps ) like for example autologous transplants in regenerative medicine, to apply for manufacturing authorizations and to manufacture cell - based therapeutics in their certified gmp manufacturing unit in a pilot clinical scale ( according to the german drug law ). orgenesis is developing an atmp for the treatment of type i diabetes based on adenovirus transduced autologous liver cells. the existing research scale production process has to be up scaled and adopted to gmp requirements in order to deliver up to 2x109 autologous liver derived cells per patient that subsequently can be transduced with an adenovirus. about 1x107 liver cells ( i. e., before ad transduction ) should be bio - banked or cryo - preserved for future use. the fraunhofer igb will perform experiments to explore the most critical production process parameters as described in the work plan section. the results of these studies should deliver the basis for the initial planning and set up of an gmp compliant production process in order to obtain a production authorization for clinical grade material to be used in a first in man study. the major goal of the planned work is to explore the key process parameters for the up scaled production of the liver derived autologous cells in order to deliver the required cell numbers, purity & functionality and in parallel reduce the cost for materials & media. the existing production methods will be transferred to the fraunhofer gmp facility. the most critical parameters for up scaling of the cell culture process will be explored and pilot studies for the sampling, storage and transport of biopsies and amplified cells will be performed. functional assays for characterizing the produced cells ( gsis assay ) will be established at the fraunhofer igb. an initial set up of qc methods and documentation according to gmp requirements will be implemented. orgenesis will provide the fraunhofer igb with all required information and sufficient amounts of human liver cells to perform the work packages described in the following sections. orgenesis will be responsible for testing of the cells