Alonso Jose Maria, Andrade Del Olmo Jon, Perez Gonzalez Raul, Saez-Martinez Virginia
I+Med. S. Coop., Parque Tecnológico de Alava. Albert Einstein 15, Nave 15, 01510 Vitoria-Gasteiz, Spain.
Polymers (Basel). 2021 Feb 22;13(4):650. doi: 10.3390/polym13040650.
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.
在设计和开发一些应用于生物医学领域的功能材料（如水凝胶）时，许多创新技术从实验室规模向工业规模的转化往往未被考虑在内。在科学领域存在知识欠缺，许多扩大到工业生产过程的方面被忽视，导致产品无法进入市场。可注射水凝胶就是一个很好的例子，我们在研究中用它来展示将基于此类产品推向市场所需遵循的不同步骤。从合成与工艺验证到所使用的表征技术以及为确保产品安全性和有效性而进行的检测，遵循相关规定，必须采用几个明确的方案。因此，鉴于对于可注射产品工业化存在知识欠缺且其具有重大意义，本文总结了所有这些方面，旨在为不熟悉该领域的科学家提供这方面的指导。更具体地说，在这项工作中，从实验室规模到工业规模开发可注射水凝胶的特性和要求从以下几个方面进行阐述：（i）用于获得具有可调所需特性的可注射水凝胶的合成技术；（ii）表征水凝胶的最常见表征技术；（iii）从监管角度来看，使可注射水凝胶实现工业化和商业化所需的必要安全性和有效性检测及方案。最后，本综述还提及并解释了一种天然透明质酸水凝胶作为可注射产品进入市场的实际开发案例。
