The project NanoGSkin has come to its end. During three years, a multidisciplinary consortium has worked jointly together in order to overcome some of the clinical barriers of the skin transplant. From a regenerative and nanomedicine approach, this project achieved to shorten the grafting time and to prevent wound infection. The basis of the project was to study the effect of nanoparticles loaded with both antibiotics and growth factors on skin tissue-engineered products. With this aim, the project was divided in 6 work packages:
- Manufacturing technology implementation. Optimisation of the biofabrication process of the bioengineered human skin substitute by the addition of nanoencapsulated rhEGF.
- Substitute implementation. Improvement of the bioengineered human skin substitute for use in patients with infected wounds by using antibiotic-loaded NPs.
- Efficacy studies. To carry out in vitro and in vivo studies to ensure efficacy of the NP supplemented bioengineered human skin.
- Nanosafety. To ensure the safety of the developed nanoformulations.
- Assembly and GMP scale-up. Design and manufacturing of the NP supplemented bioengineered skin under GMP or GMP-like environment.
- Viability, dissemination and worldwide market access. Adequate exploitation of the results and dissemination to the relevant stakeholders by generating an adequate business model to get a fast market entrance of products and a sustainable life cycle of product.
As a result of this coordinated work, the planned milestones of the project were achieved:
M1: Manufacturing production and scale-up process of NPs
A rhEGF-NPs batch under GMP-like conditions was successfully released as all the specifications and requirements were met according to GMP regulation. In addition, the manufacturing of antibiotic-LNPs using benchtop microfluidic equipment was proved to be an automatized, easily controlled and reproducible method with the potential of scaling up for larger volumes for the pharmaceutical industry.
M2: Biosafety confirmation of the bioengineered human skin substitute combined with NPs
The addition of loaded-NPs to the human skin substitute does not affect structure neither functionality of the artificial tissue. In vivo studies to prove biosafety of the NPs were carried out with no evidence of dermal histopathological observations.
M3: Efficacy confirmation of the bioengineered human skin substitute combined with NPs
Some in vitro efficacy studies of rhEGF-NPs and antibiotic-NPs demonstrated that loaded-NPs can be used to induce proliferation of human skin keratinocytes and to induce antibacterial effect, respectively.
M4: Exploitation plan
Efforts were made to assess product viability and market take-up of the functionalized skin substitute. In this sense, a marketing and business plan were elaborated as well as a preliminary cost analysis.
For more information about the project results, you can check the media centre where open access publications and communications were uploaded.