WP04: GMP-production of denovoDerm and denovoSkin and their adaptation to clinical requirements

Objectives

The main objective of WP04 is the GMP production of the two skin grafts, designated denovoDerm and denovoSkin. For Phase 1 and 2 clinical trials, safe and highly functional denovoDerm and denovoSkin are to be routinely produced under GMP conditions in the three clinical centres. Phase 3 clinical studies are envisaged thereafter. The major objectives of WP04 are:

Objective 1: Establishing and optimizing the GMP-production process of denovoDerm and denovoSkin in a brand new GMP-facility.

Objective 2: GMP production of the denovoDerm and denovoSkin for the Phase1 and Phase2 clinical trials.

Objective 3: The permanent adaptation of the two types of skin substitutes, denovoDerm and denovoSkin to clinical requirements throughout the duration of the project.

Objective 4: Transfer of the technology to produce the denovoDerm and denovoSkin to Partner 02 (VUA) and the Partner 03 (UKB), to enable these to produce the substitutes at place.

Objective 5: Dissemination of the corresponding data and technology.

Workpackage Description

WP04 (UZH-TBRU, the Coordinator) will work on producing the denovoDerm and denovoSkin for Phase1 and Phase2 clinical trials.