Tissue engineering and regenerative medicine: manufacturing challenges.

Area of Science:

• * Interdisciplinary fields combining engineering and life sciences.
• * Focus on developing biological substitutes to restore, maintain, or improve tissue function.

Background:

• * Tissue engineering and regenerative medicine technologies are largely at laboratory or pre-commercial stages.
• * Commercialization requires overcoming significant manufacturing and bio-process challenges.
• * A three-generation roadmap structures the analysis of these challenges.

Purpose of the Study:

• * To review manufacturing and bio-process challenges in commercializing tissue engineering and regenerative medicine.
• * To define the manufacturing community's role in the success of these emerging fields.
• * To identify research areas by outlining a roadmap of industry generations.

Main Methods:

• * Analysis structured by a three-generation industry roadmap: first (marketed products), second (emerging applications), and third (aspirational applications).
• * Focus on cost reduction for first-generation products.
• * Identification of technological and value chain needs for second-generation products.

Main Results:

• * First-generation industry requires cost reduction for market penetration and patient impact.
• * Second-generation industry needs advancements in 3D tissue structure creation and value chain optimization.
• * Third-generation industry challenges are rooted in fundamental biological and clinical science.

Conclusions:

• * Addressing manufacturing and bio-process challenges is crucial for the commercial success of tissue engineering and regenerative medicine.
• * A generational roadmap highlights specific needs, from cost reduction to fundamental scientific advancement.
• * Further research is needed across all generations to facilitate the translation of laboratory discoveries into clinical practice.