4.7 Review

Injectable Hydrogels: From Laboratory to Industrialization

Journal

POLYMERS
Volume 13, Issue 4, Pages -

Publisher

MDPI
DOI: 10.3390/polym13040650

Keywords

injectable; hydrogels; industrialization; scale-up; polysaccharides; regulation

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This paper discusses the importance of translating innovative technologies from the laboratory to industrial scale, specifically focusing on injectable hydrogels in the biomedical field. It highlights the various steps and protocols needed for the industrialization of such products, emphasizing the significance of following regulations and ensuring safety and efficacy. Additionally, a real example of a natural hyaluronic acid hydrogel reaching the market as an injectable product is provided as a case study.
The transfer of some innovative technologies from the laboratory to industrial scale is many times not taken into account in the design and development of some functional materials such as hydrogels to be applied in the biomedical field. There is a lack of knowledge in the scientific field where many aspects of scaling to an industrial process are ignored, and products cannot reach the market. Injectable hydrogels are a good example that we have used in our research to show the different steps needed to follow to get a product in the market based on them. From synthesis and process validation to characterization techniques used and assays performed to ensure the safety and efficacy of the product, following regulation, several well-defined protocols must be adopted. Therefore, this paper summarized all these aspects due to the lack of knowledge that exists about the industrialization of injectable products with the great importance that it entails, and it is intended to serve as a guide on this area to non-initiated scientists. More concretely, in this work, the characteristics and requirements for the development of injectable hydrogels from the laboratory to industrial scale is presented in terms of (i) synthesis techniques employed to obtain injectable hydrogels with tunable desired properties, (ii) the most common characterization techniques to characterize hydrogels, and (iii) the necessary safety and efficacy assays and protocols to industrialize and commercialize injectable hydrogels from the regulatory point of view. Finally, this review also mentioned and explained a real example of the development of a natural hyaluronic acid hydrogel that reached the market as an injectable product.

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