Guidelines for establishing a 3-D printing biofabrication laboratory

Area of Science:

• Biotechnology and Biomedical Engineering
• Advanced Manufacturing in Healthcare

Background:

• Healthcare is rapidly adopting advanced manufacturing and 3D printing.
• Interdisciplinary advancements have yielded clinical applications like anatomical models and regenerative bioscaffolds.
• Existing research primarily focuses on materials, designs, processes, and products, neglecting facility requirements.

Purpose of the Study:

• To address the gap in facility design for clinically relevant biofabrication solutions.
• To provide guidelines for designing biofabrication laboratories.
• To facilitate the clinical translation of engineered tissues and organs.

Main Methods:

• Review of current and forward-thinking guidelines for biofabrication laboratories.
• Analysis of facility requirements for overcoming clinical translation hurdles.
• Focus on standardization for reproducibility, quality control, and commercialization.

Main Results:

• Identified critical facility design elements for biofabrication.
• Highlighted the need for standardized facilities, equipment, and processes.
• Emphasized the role of automation and information systems in large-scale manufacturing.
• Provided guidelines for therapeutic and non-therapeutic biofabrication applications.

Conclusions:

• Standardized biofabrication facilities are essential for clinical translation.
• Proper facility design is key to ensuring reproducibility, quality control, and commercialization.
• Guidelines presented will aid in establishing effective biofabrication laboratories for tissue engineering.