The lyophilisate is to be reconstituted with sterile water for injection before use. GM-CSF is provided as a lyophilised pow der containing 0.1 mg of active substance for reconstitution in sterile water for injection to be given via intradermal injection. Gemcitabine is provided as a lyophi lised powder (vials of 200 mg and 1 g) for reconstitution in saline to be given via intravenous injection. To be reconstituted according to Prescribing Information for gemcitabine . CT TG01 -01 Version v 10.0 27 June 2018 Confidential 52 / 87 5-FU is provided as a solution for intravenous injection (vials of 500mg in 10 mL) . To be administered according to the Prescribing Information for 5- FU. Leucovorin is provided as a solution for intravenous injection (10mg/ml) . To be administered according to Prescribing Information for Leucovorin. All handling of the Investigational Medicinal Product at the supply company and at site should be in compliance with normal handling of sterile products for injection and should follow the to the current Good Manufacturing Practice (GMP) guidelines. Further descriptive information on the products can be found in the IB. 4.1.1 Packaging and labelling of the investigational product From the documentation of the trial medication, it must be possible to retrace the handling, composition and pharmaceutical quality of the investigational product according to the current Good Manufacturing Practice (GMP) guidelines. 4.1.1.1 TG01 TG01 will b e packaged and labelled by ”AndersonBrecon” , a specialised pharmaceutical clinical supply company located in Hereford, UK , in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) requirements. The vials and boxes will be labelled according to local regulatory requirements. The trial medication will be supplied to the investigational site (s) in a box containing a defined number of vials. TG01 will be shipped to the investigational site s under controlled, frozen ( -20 oC) conditions. 4.1.1.2 GM-CSF GM-CSF will be package and labelled by “AndersonBrecon ”, a specialised pharmaceutical clinical supply company located in Hereford, UK , in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) requirements. The vials and boxes will be labelled according to local regulatory requirements. The trial medication will be supplied to the investigational sites in a box containing “ a defined number of vials ”. GM-CSF will be shipped to the investigational s ite(s) under controlled, refrigerated conditions (2 -8oC). 4.1.1.3 Chemotherapy Commercially available chemotherapy ( gemcitabine or 5-FU and Leucovorin) will be used. 4.1.2 Storage, issue, and return of investigational product Upon receipt of the medication, the Investi gators, or the responsible pharmacist, will inspect the medication and send back the acknowledgment of receipt form that is enclosed with the parcel, duly completed and signed.