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.

由于水凝胶疗法已被引入临床治疗程序，生物医学行业必须面临技术转让和工艺规模化的问题。这将是新技术实施路线图的关键。转移技术和放大技术在某些应用中已经众所周知，但其他应用（例如 3D 打印）仍然具有挑战性。与其他天然凝胶相比，脱细胞组织具有许多优点，例如，由于它们能够保存天然分子，因此它们显示出增强的生物特性。因此，尽管它们作为生物墨水的来源对放大过程来说是一个挑战，但考虑克服这一挑战所带来的优势非常重要。因此，应考虑影响工业过程规模的许多方面，例如向水凝胶中添加药物或细胞，而且，胶凝过程对于确定必须控制的化学和物理参数非常重要，以保证成功的过程。在扩大工艺规模时，法律方面也至关重要，因为从监管的角度来看，它们决定了工业实施的成功。在此背景下，将考虑关于生物医学器械的新法规 (EU) 2017/745。本综述总结了在扩大天然水凝胶规模时应考虑的不同方面，包括法律方面，以平衡这些不同方面并优化原材料和发动机方面的成本。