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According to Health Resources & Services Administration (HRSA), in the US about 110,000 people are waiting for organs right now and about 20 patients die each day waiting for a transplant1. Due to shortage of donors and requirements for matching, there is a huge demand for manufactured tissues and organs. Bioprinting has emerged as a very promising tool for solving this major unmet need in healthcare.
Convergence of cell biology, biomaterials and 3D printing technologies have increased feasibility towards manufacturing organs in the lab. While recent progress has transpired miniaturized tissues and organs up to centimeters in scale2, 3, several challenges limit the translation into the clinic. In this blog post we will summarize some of the key technical challenges in the field and the enabling technologies needed for clinical translation of bioprinting.
A major technological hurdle for fabricating larger tissue constructs is the need to form a blood supply that is essential for keeping cells alive via delivery of nutrients, transfer of gases and removal of waste. Current technologies are unable to recreate the intricate blood vessel network seen in our organs. Although bioprinters capable of printing at sub-micron resolution have emerged4, they are still not yet suitable for large scale production of tissues. This complex multidisciplinary problem requires a combination of emerging technologies to be overcome. Recent advances in stem cell research have led to the discovery of induced pluripotent stem cells (iPSCs) which have created new opportunities in tissue fabrication as these cells can become any cell types in the body5. However, precise growth factor delivery mechanisms would be necessary for successful utilization of promising iPSC technologies to create complex multicellular organization similar to native tissues.
In addition to these technological challenges, many infrastructures and logistical related hurdles remain ahead of full clinical translation. Currently, there are no GMP grade containment systems available for bioinks. GMP-grade bioink materials are also limited, and in most cases, need to be reformulated by the user which introduces significant risk of contamination and variability. GMP grade syringes and cartridges must be designed specifically for clinical bioprinting. Awareness and understanding in the field about particulates, extractables, leachables and container closure integrity are much needed. Non-contact and non-destructive tissue characterization tools also need to be developed for studying critical quality attributes of these fabricated tissues for successful clinical translation. Finally, strategies for long term preservation and transportation are also vital in making tissue and organ manufacturing a commercially viable process.
Despite these challenges, the bioprinted and tissue engineering products are rapidly progressing towards clinical trials6,7. These developments are being driven by considerable investment from corporate collaborations between Pharma8-11 and tools providers12-14. These advances will continue to accelerate this translation toward overcoming the debilitating organ shortage challenge.
West is participating in several research projects and industry consortia in this exciting field. Contact us today to learn more.
Take an in-depth look at the science behind containment & delivery of injectable medicines in the West Knowledge Center.