Wolfson School for Mechanical, Electrical and Manufacturing Engineering, Centre for Biological Engineering, Loughborough University, Leicestershire, United Kingdom.
Wolfson School for Mechanical, Electrical and Manufacturing Engineering, Centre for Biological Engineering, Loughborough University, Leicestershire, United Kingdom.
Cytotherapy. 2018 May;20(5):759-767. doi: 10.1016/j.jcyt.2018.01.007. Epub 2018 Apr 16.
Since the regenerative medicine sector entered the second phase of its development (RegenMed 2.0) more than a decade ago, there is increasing recognition that current technology innovation trajectories will drive the next translational phase toward the production of disruptive, high-value curative cell and gene-based regenerative medicines.
To identify the manufacturing science problems that must be addressed to permit translation of these next generation therapeutics.
In this short report, a long lens look within the pluripotent stem cell therapeutic space, both embryonic and induced, is used to gain early insights on where critical technology and manufacturing challenges may emerge.
This report offers a future perspective on the development and innovation that will be needed within manufacturing science to add value in the production and commercialization of the next generation of advanced cell therapies and precision medicines.
十多年前，再生医学领域进入了发展的第二阶段（RegenMed 2.0），人们越来越认识到，当前的技术创新轨迹将推动下一转化阶段朝着生产具有颠覆性、高价值的治疗性细胞和基因再生医学的方向发展。
确定必须解决的制造科学问题，以实现这些下一代治疗药物的转化。
在本短报告中，通过对多能干细胞治疗领域（包括胚胎和诱导多能干细胞）的深入研究，我们获得了早期的见解，了解到可能出现关键技术和制造挑战的地方。
本报告对制造科学领域未来的发展和创新进行了展望，这将为下一代先进细胞疗法和精准药物的生产和商业化增加价值。
