Natural hydrogels R&D process: technical and regulatory aspects for industrial implementation

J Mater Sci Mater Med. 2020 Jul 21;31(8):64. doi: 10.1007/s10856-020-06401-w.

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.

Publication types

  • Review

MeSH terms

  • Biocompatible Materials / chemical synthesis
  • Biocompatible Materials / chemistry
  • Biocompatible Materials / therapeutic use
  • Biological Products / chemical synthesis*
  • Biological Products / chemistry
  • Biological Products / therapeutic use
  • Biomedical Research* / legislation & jurisprudence
  • Biomedical Research* / methods
  • Biomedical Technology / legislation & jurisprudence
  • Biomedical Technology / methods
  • Cross-Linking Reagents / chemistry
  • Humans
  • Hydrogels / chemical synthesis*
  • Hydrogels / chemistry
  • Hydrogels / therapeutic use
  • Medical Device Legislation
  • Polymerization
  • Printing, Three-Dimensional
  • Research

Substances

  • Biocompatible Materials
  • Biological Products
  • Cross-Linking Reagents
  • Hydrogels