Natural hydrogels R&D process: technical and regulatory aspects for industrial implementation
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SPECIAL ISSUE: HYDROGELS IN REGENERATIVE MEDICINE Original Research
Natural hydrogels R&D process: technical and regulatory aspects for industrial implementation Marta Calvo Catoira 1,2 Javier González-Payo Francesca Boccafoschi 1,2,4 ●
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Luca Fusaro
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Martina Ramella
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Received: 30 August 2019 / Accepted: 8 July 2020 © The Author(s) 2020
Abstract Since hydrogel therapies have been introduced into clinic treatment procedures, the biomedical industry has to face the technology transfer and the scale-up of the processes. This will be key in the roadmap of the new technology implementation. Transfer technology and scale-up are already known for some applications but other applications, such as 3D printing, are still challenging. Decellularized tissues offer a lot of advantages when compared to other natural gels, for example they display enhanced biological properties, due to their ability to preserve natural molecules. For this reason, even though their use as a source for bioinks represents a challenge for the scale-up process, it is very important to consider the advantages that originate with overcoming this challenge. Therefore, many aspects that influence the scaling of the industrial process should be considered, like the addition of drugs or cells to the hydrogel, also, the gelling process is important to determine the chemical and physical parameters that must be controlled in order to guarantee a successful process. Legal aspects are also crucial when carrying out the scale-up of the process since they determine the industrial implementation success from the regulatory point of view. In this context, the new law Regulation (EU) 2017/745 on biomedical devices will be considered. This review summarizes the different aspects, including the legal ones, that should be considered when scaling up hydrogels of natural origin, in order to balance these different aspects and to optimize the costs in terms of raw materials and engine. Graphical Abstract Technical consideraons Machine opmizaon
Suitable biomaterial Process opmizaon
Economic feasibility study
Medical device regulaons Class ClassIIIIII device device
CE cerficaon obtained Device Device follow-up follow-up
SCALEUP
Business plan
Market study
Financial risk management
1 Introduction * Francesca Boccafoschi [email protected] 1
Center for Translational Research on Autoimmune & Allergic Diseases–CAAD, 28100 Novara, Italy
2
Tissuegraft srl, 28100 Novara, Italy
3
Telecomunicación, Department of Signal Theory and Communications, University of Vigo, 36310 Vigo, Spain
4
Department of Health Sciences, University of Piemonte Orientale, 28100 Novara, Italy
The scale-up process is part of a more complex process of technology transfer from the laboratory to an industrial scale. Scale-up enters into the science of chemical engineering and it attempts the obtainment of a product in the laboratory with the same characteristics and performance on a larger scale. Also, other processing
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