**Abstract**

Organoids are 3D miniature tissue mimics and have been effectively used for various purposes, including disease modeling, various drug screening, mechanism of pathogenesis, stem cell research, and tumor immunology. Organoids are as varied as the body's tissues and organs and have enormous economic potential. They can open new ways to tailored therapy and precision medicine. In clinical investigations, patient-derived organoids have been used to predict patient responses to therapeutic regimens and perhaps improve cancer treatment outcomes. Recent developments in stem cell research and genomic technologies have led to breakthrough innovations in organoid bioengineering, large-scale manufacturing, biobanking, and commercialization. This chapter reviews the notion of organoid biobanking, companies involved and the commercialization aspect, and ethical considerations.

**Keywords:** organoid, tumoroids, commercialization, biobank, cell atlas

## **1. Introduction**

Organoids are miniature 3D models of *in vivo* tissues and organs and faithfully mimic their structures and functions. These in vitro near-physiological models provide unique opportunities for diverse basic and translational human research applications [1]. Adult stem/progenitor cells from normal or diseased tissues are extracted for organoid creation. Guided differentiation of induced pluripotent stem cells (iPSCs), embryonic stem cells, and adult stem cells is followed by 3D culture on extracellular matrix using an appropriate culture medium to initiate organoid culture [2]. Long-term preservation of cells and organoids in biobanks is critical for future disease modeling, therapeutic development, regenerative medicine, toxicological studies, preclinical and personalized medicine (**Figure 1**). It is now possible to create organoids from various human tissues, including the airway, lungs, heart, brain, liver, brain, breast, gut, pancreas, and kidney (**Figure 2**) [3]. Another significant development is in the area of tumor organoids, which has opened up new avenues for humanspecific tumor investigations, preclinical tumor studies, translating cancer research from the bench to the bedside [4].

Backed by some significant observations in the proliferative nature of adult tissue stem cells in 2009, the cardinal notion enveloping organoid technology is that stem cells have ingrained potential to self-assemble into 3D constructs with similitude with human organs [5]. As time rolled on, the modus operandi has been implemented

#### **Figure 1.**

*Organoid formation from stem and progenitor cells. Following tissue dissociation, adult stem cell/ progenitor cells from normal or patients are isolated. Induced pluripotent stem cells (iPSCs), embryonic stem cells and adult stem cells are subjected to guided differentiation, followed by growing them on extracellular matrix in 3D culture system using specific culture media to begin organoid culture. The lower right section shows the different aspects of organoid commercialization, including molecular profiling of the collected cells, long term storage of cells with appropriate patient consent and information. These biobanked organoids can then be used for functional studies related to potential applications like disease modeling, therapeutic development, regenerative medicine, toxicology, and personalized medicine.*

to produce several human and murine organoids out of epithelial tissues of various organs such as the liver, intestine, kidney, skin [6–9]. Another breakthrough entails the evolution of organoids obtained from induced pluripotent stem cells (iPSC), which can circumvent the toil to avail specific tissues like the heart or brain. This prodigious prospect, reinforced with genetic engineering, permits the mutational corrections in patient-derived iPSCs expediting differentiation to generate a specific type of cells [10–13]. Scrupulous experimental manipulation while maintaining sensitive biological complexity allows organoid technology to bridge the gap between 2D cell culture and 3D models [14]. It has also proved to better simulate human physiology than animal models and has shown the promise to substitute animals in preclinical biology [15, 16].

As ratiocinated from the trends, there will be a steady increase in the demand for organoid technology in the following years [3, 16]. As per reports published in various media, around 20 companies are into business with this technology—their activities include biobanking, manufacturing, commercialization, the implication of robotics for the development of organoids, organoids on a chip, etc. Statistically, priorities are given to heart, brain, intestine, and kidney organoids [3]. Financial models adopted by these companies are—(i) venture capitals, (ii) partnerships (iii) direct collaboration with the originators. Routine use of animals for disease modeling has always been afflicted with stringent moral and ethical queries. Usage of embryonic stem cells has also faced stormy skirmishes regarding the moral status of the embryos. Likewise, the moral and legal status of the organoids has been called in regulatory questions, to mention a few—ownership, consent, IP rights, safety, commercialization, etc.

**Figure 2.**

*Tissue specific organoid bioenginnering and different basic biomedical and commercial applications.*

Utilization of 'matrigel' (extracellular matrix obtained from animals) has raised some safety concerns regarding compatibility with the human system. The debate revolving around the exchange or donation of human tissue as a commodity is still ongoing. To resolve this, few regulations should be declared and accepted by the global intellect [17]. Quibbles for intellectual property (IP) generation with human tissue should cease to persist, showing proper dignity and preserving the donor's rights. Consent should become a requirement avoiding de-identification of the donor [18–21]. In the present chapter, we shall highlight the usage of the organoid, organoid cell atlas, followed by shedding light on the commercialization aspect of the technology and future directionality.
