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The Synthesis of RGD-functionalized Hydrogels as a Tool for Therapeutic Applications
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Natural hydrogels R&D process: technical and regulatory aspects for industrial implementation.
Marta Calvo Catoira1,2, Javier González-Payo3, Luca Fusaro2,4
1Center for Translational Research on Autoimmune & Allergic Diseases-CAAD, 28100, Novara, Italy.
Journal of Materials Science. Materials in Medicine
|July 23, 2020
Summary
Scaling up hydrogel therapies requires careful consideration of technology transfer, especially for 3D printing applications. This review examines key factors, including decellularized tissues, process parameters, and legal aspects under new EU regulations.
Area of Science:
- Biomaterials Science
- Regenerative Medicine
- Biotechnology
Background:
- Hydrogel therapies are increasingly used in clinical treatments, necessitating industrial scale-up.
- Technology transfer and process scaling are critical for implementing new hydrogel technologies.
- Decellularized tissues offer superior biological properties for bioinks but pose scale-up challenges.
Purpose of the Study:
- To review critical aspects of scaling up natural hydrogels for industrial applications.
- To address challenges in technology transfer and process scale-up for hydrogel therapies.
- To consider the impact of regulatory frameworks, such as EU Regulation 2017/745, on hydrogel scale-up.
Main Methods:
- Literature review of technology transfer and scale-up processes for hydrogels.
- Analysis of factors influencing hydrogel industrialization, including bioink sources and process parameters.
- Examination of legal and regulatory considerations for biomedical devices.
Main Results:
- Scaling up hydrogel production involves challenges in areas like 3D printing and the use of decellularized tissues.
- Controlling chemical and physical parameters during gelling is essential for process success.
- Legal and regulatory compliance, particularly with Regulation (EU) 2017/745, is vital for market implementation.
Conclusions:
- Successful scale-up of natural hydrogels requires a holistic approach, balancing technical, biological, and regulatory factors.
- Optimizing costs for raw materials and manufacturing is crucial for economic viability.
- Addressing these multifaceted aspects will facilitate the broader clinical adoption of advanced hydrogel therapies.
