The key questions of the 3D printed organ market
The technology challanges, regulation, and supply chain.
Currently, 3D bioprinting research focuses on drug discovery and toxicity applications (in vitro), or tissue and organ modeling (in vivo). There are research projects focussed on bioprinted 3D tumor models, which mimic the actual tumor environment, or projects which aim to create realistic 3D tissue constructs with the potential to implant them in the human body in future clinical applications. However, setting up bioprinters in healthcare organisations and printing transplantable organs is still far from today.
At present, the bioprinting of fully functional complex internal organs, such as hearts, kidneys, and livers, is still far away. One of the limiting factors in achieving 3D printed organs for transplant is the size. Currently, researchers can create miniaturized tissue resembling natural tissue, but many of these constructs are not capable of achieving a therapeutic impact due to their small size.
The other key issue is the complex network of cells, tissues, nerves, and structures in a human organ. They need to be positioned with the highest precision so that the organ functions properly. Currently, we do not have the technology to precisely blueprint these complex networks using different materials, cell types and bio-inks in the same final structure.
The technology challenges being faced by the bioprinted industry
There are three key challenges of bioprinting: the printer technology, the biomaterials, and the vasculature of the printed construct.
Bioprinter technologiesneed to increase resolution and speed and should be compatible with a wide spectrum of biocompatible materials. Higher resolution will enable better control in the 3D microenvironment.
Biomaterials are undoubtedly the primary limitation of this technology. Today, we are limited to several biocompatible natural and synthetic bio-inks. Natural bio-inksprovide an excellent microenvironment capable of mimicking the native ECM, while thesynthetic materials provide good mechanical strength and can be modified to promote cell attachment, proliferation, and differentiation. The ideal would be a biocompatible, synthetic, modifiable and modular system. A base material in which mechanical properties can be easily adapted for the chosen additive method and then formulated for each specific cell type or multiple cell types involved in the end application.
Finally, there is a fundamental challenge with the vasculature of the printed construct. In vivo, the tissue is continually fed by sufficient oxygen and nutrients.If the tissue is constructed using a bioprinter, then it also needs a vascular system. Diffusion by itself will only work up to 150-micrometer thickness. Beyond this thickness, the tissue will not develop properly. Though researchers have made significant advancements in understanding the processes involved in vascular development and function, we do not yet have sufficient knowledge to recreate vascular structures in vitro. If we hope to understand the complex biology of in vivosystems, we must find ways to recapitulate in vitro the major architectural features found in living organisms, particularly multi‐scale, branched vasculature and the associated convective and diffusive transport.
The regulations of bioprinted products in clinical applications
At the moment there are no regulations for bioprinting applied to research applications. However, bioprinted regenerative medicine products used in clinical applications will need to satisfy FDA and or GMC regulatory oversight in the future. The regulators have an active program for assessing and evaluating bioprinting in order to develop future regulations for bioprinting applications in the clinic.
Building on guidance published by the FDA detailing a list of what is not considered a human organ, there is an assumption that the 3D printed organs will not be regulated as human organs for transplantation. Although regulations cannot reflect a class of product that does not yet exist, the market players think that 3D printed organs will be more likely to be regulated as a drug, device, and or biological product.
In the clinical environment, the challenge will be associated with the manufacturing process and costs. Today, there are two FDA regulations that outline the minimum production requirements in clinical products. These are the Good Manufacturing Practices (cGMPs) and Good Tissue Practices (cGTPs). The cGMPs are applicable to the facilities that print the organs. The cGTPs are applicable to the facilities that extract and handle the biopsied human cells. These regulations will need to be applied by the healthcare organisations that wish to print human organs in-house. The set up of these production lines can be costly, which might raise the question of the development of such 3D bioprinting-centers.
The supply chains in bioprinted organ market will work differently
Currently, the major end-users of bioprinting technologies are the universities and research institutes. In addition, we also see cosmetic and pharmaceutical companies establishing internal research groups with a focus on bioprinting applications. Howeves, in the future, it is anticipated that healthcare organisations, clinicians and patients will also play a role.
Thus, whilst today the supply chains work similar to other life science products, industry players expect to see rapid transformation of the procurement strategies as this bioprinting market develops. Healthcare organisations will restructure their tender specifications with a special focus on service and or performance-based logic. Furthermore, the market might also consider the creation of public hubs for 3D bioprinting at the regional level. Since the application of bioprinting technologies to evolve organ supply chains can offer healthcare organisations strong value and a competitive advantage.
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