WP02: Production of NovoMaix and characterization of matrix materials

Objectives

The main objective of Workpackage WP02 is the production of all sponge based matrix materials. Furthermore, the characterization of all cell-free matrix material used during the clinical trials (collagen hydrogels, collagen sponges) will be performed, in order to understand to which extent they have an impact on clinical results.

The following objectives will be accomplished:

  1. Ensure that the development of NovoMaix scaffolds (collagen sponge branch of study) complies with ISO 13485 regulations, that its production is performed under GMP conditions and that the prepared IMPD fulfills the required standards.
  2. Ensure that the preclinical characterization of the different scaffold materials (collagen hydrogels, collagen sponges) regarding nativity, biodegradation, mechanical properties will be accomplished.
  3. Review of material related questions of the clinical trial Phase 1 and potential initiation of design changes for Phase 2. Review of potentially performed design changes for Phase 2 and potential initiation of IMPD modifications before Phase 2 clinical trial.
  4. Spin-off developments and synergies with hydrogel developments in WP04 by e.g. combination of fragile hydrogels with stabilizing collagen scaffolds to improve clinical handling properties.
  5. Review of material property related questions after end of clinical trials.

Workpackage Description

Task 1: Characterisation of collagen-based materials
In WP02 all collagen-based materials will be characterized regarding the parameters listed below in order to cover essential aspects of the design documentation which are prerequisite for clinical studies.

  • Nativity of the collagen-based materials will be characterized for the collagen sponges (NovoMaix) and the collagen hydrogels (for denovoDerm & denovoSkin).
  • Purity & Amino Acid Analysis will be performed for collagen sponges and hydrogels.
  • Mechanical properties will be determined & compared.
  • Optimal thickness of both scaffold materials for clinical trials will be defined considering design input requirements from Partner 01a (UZH-TBRU), Partner 02 (VUA), and Partner 03 (UKB).
  • In-vitro-degradation behaviour of collagen hydrogels and collagen sponges will be characterized in collagenase digestion studies.
  • Molecular and biochemical analysis of collagen sponges and hydrogels will be performed by Partner 04 (RUNMC).

Task 2: Production and transfer
GMP production and transfer of suitable NovoMaix collagen sponge scaffolds for both clinical trials and assistance of Partner 01a (UZH-TBRU) regarding selection of collagen hydrogels and production environment for denovoDerm & denovoSkin production for the clinical trials.