Work Package 1 – Production of the bio-inks and carry out preliminary printability tests.
This workpackage will design peptide-functionalized ELPs with the correct LCST and enzyme responsive nanocapsules that can be incorporated to DH-based bio-ink. In addition, quantify the bioadhesive properties and adjust the biodegradability/release of the formulated bio-inks. Development of 3 bio-inks (DH+antibacterial, DH+anti-inflammatory, DH+ELP-Peptide/WC) that meet bioprinting requirements.
- Design of ELPs and enzyme-responsive polypeptides.
- Formulation and Characterization of stimuli-responsive nanocapsules
- Formulation & Rheological prop. Of the combined bio-inks
- Study of the bioadhesive properties.
- Release & biodegradability studies of the combined bio-ink
- Preliminary 3D printing of formulated bio-inks.
Work Package 2 – Establishment of the customized 3D printing protocol to generate the complete scaffold.
This workpackage involves several key stages, including establishing the initial requirements and needs for the 3D bioprinting protocol, designing and developing a customized 3D bioprinter prototype, creating new software for customized 3D printing trajectories, achieving hierarchical printing and mechanical properties simulation, and carrying out testing and validation of the 3D printing protocol.
- Establish the initial requirements of the 3D bioprinting protocol
- Design and development of the customized 3D bioprinter prototype
- Design and development of a new high-level software for customized 3D printing trajectories
- Development of a new software for mechanical simulation of the wound dressing model
- Testing and validation of the 3D printing protocol
Work Package 3 – Implementation of in vitro and in vivo models for chronic wound to test the scaffold safety and efficacy.
This workpackages aims to select the most efficient nanocapsules and estimate the concentration range of bioactive compounds, demonstrate the multifunctionality of 3D printed wound dressing in vitro, establish a protocol to determine the contractile force to be applied to the wound, and determine the biological effects of 3D dressings and their individual components on human cells in the presence of chronic wound exudates from individual patients.
- Antibacterial Properties & Biofilm interaction of bio-ink and combined product
- Innervation and angiogenesis in vitro studies
- In vitro cytotoxicity & cell recruiting
- Immunological response of the 3D printed scaffold and its components
- Bioadhesive properties and contractile force on relevant tissue
- Efficacy of the individual and combined biological Compounds on Human WE
Work Package 4 – Implementation of in vitro and in vivo models for chronic wound to test the scaffold safety and efficacy.
This workpackage focuses on determining the PK/PD of single components, validating the 3D printed wound dressing in non-healing wounds, establishing an aging pig model, and preventing microbial infection.
- Evaluation of bio-ink and its component on acute wound pig model
- In vivo biocompatibility and immunological studies
- Validation of bio-ink on chronic wound pig model
- Generation of an aging pig model.
Work Package 5 – Transversal WP that will deal with regulation
This workpackage focuses on establishing a regulatory pathway for the 3D printed dressing to accelerate its development, establishing a production process that is scalable via QbD according to regulatory requirements, producing the final 3D printed dressing to be validated in WP4, and facilitating transfer to GP production and pre-clinical regulatory.
- Regulatory pathway
- QbD of Bio-ink and its component
- Scale-up & production of the bio-ink and 3D printed dressing GMP-like conditions
- SOPs of multifunctional 3D printed dressing
Work Package 6 – Oversee innovation management and project management
This workpackage focuses on communication, creating visibility, and encouraging project outreach, disseminating results to targeted stakeholders and the scientific community, fostering innovation capacity and exploitation of results (including IP management), proposing an HTA framework, performing health economic assessment, and evaluating marketing requirements.
- Project communication
- Dissemination of project results
- IPR Strategy
- HTA, health economics and marketability
Work Package 7 – Oversee innovation management and project management
This workpackage covers the set-up of management and communication structures and processes, central monitoring of project activities, deliverables, and deadlines to ensure timely and qualitative achievement of project results through scientific coordination and impact-oriented project management, ensuring efficiency, high quality, and maximum usability of project outcomes, and proper risk-analysis and conflict management.
- Implementation of efficient management & support structures
- Scientific coordination, quality assurance & risk management
- Legal & contractual setting
- Reporting, financial management & controlling