Pharmaceutical formulation and polymer chemistry for cell encapsulation applied to the creation of a lab-on-a-chip bio-microsystem.

Microencapsulation of formulation designs further expands the field and offers the potential for use in developing bioartificial organs via cell encapsulation. Combining formulation design and encapsulation requires ideal excipients to be determined. In terms of cell encapsulation, an environment which allows growth and functionality is paramount to ensuring cell survival and incorporation into a bioartificial organ. Hence, excipients are examined for both individual properties and benefits, and compatibility with encapsulated active materials. Polymers are commonly used in microencapsulation, offering protection from the immune system. Bile acids are emerging as a tool to enhance delivery, both biologically and pharmaceutically. Therefore, this review will focus on bile acids and polymers in formulation design via microencapsulation, in the field of bioartificial organ development.

Progress of 3D Bioprinting in Organ Manufacturing

Three-dimensional (3D) bioprinting is a family of rapid prototyping technologies, which assemble biomaterials, including cells and bioactive agents, under the control of a computer-aided design model in a layer-by-layer fashion. It has great potential in organ manufacturing areas with the combination of biology, polymers, chemistry, engineering, medicine, and mechanics. At present, 3D bioprinting technologies can be used to successfully print living tissues and organs, including blood vessels, skin, bones, cartilage, kidney, heart, and liver. The unique advantages of 3D bioprinting technologies for organ manufacturing have improved the traditional medical level significantly. In this article, we summarize the latest research progress of polymers in bioartificial organ 3D printing areas. The important characteristics of the printable polymers and the typical 3D bioprinting technologies for several complex bioartificial organs, such as the heart, liver, nerve, and skin, are introduced.

Ethics of First-in-Human Transplantation Trials of Bioartificial Organs

"The most effective treatment for type 1 diabetes is transplantation of either a whole pancreas from a deceased donor or islet cells derived from multiple deceased donors. However, transplantation has several limitations, including shortage of post-mortem donors and the need for post-transplant patients to use life-long immunosuppressive medication. In the last decade, the field of regenerative medicine has combined engineering and biological technologies in the attempt to regenerate organs. The European VANGUARD project aims to develop immune-protected bioartificial pancreases for transplantation into non-immunosuppressed type 1 diabetic patients. This project is creating a ‘combination product’ using cells and tissue from a variety of sources, including placentas and deceased donors. The clinical development of this complex product raises ethical questions for first-in-human (FIH) clinical trials. Under what conditions can bio-artificial organs safely are transplanted in humans for the first time? How can patients be selected, recruited and informed responsibly? In this presentation, we investigate the ethical conditions for clinical trials of bio-engineered organs, focusing inter alia on study design, subject selection, risk-benefit assessment, and informed consent. We present the results of a review of the literature on the ethics of clinical trials in regenerative medicine, cell and gene therapy and transplantation, and specify existing ethical guidance in the context of FIH transplantation trials of bioartificial organs. We conclude that this new and innovative area at the intersection of regenerative medicine, cell and gene therapy and transplantation requires adequate consideration of the ethical issues in order to guide responsible research and clinical implementation. "

Advancements in Assessments of Bio-Tissue Engineering and Viable Cell Delivery Matrices Using Bile Acid-Based Pharmacological Biotechnologies

The utilisation of bioartificial organs is of significant interest to many due to their versatility in treating a wide range of disorders. Microencapsulation has a potentially significant role in such organs. In order to utilise microcapsules, accurate characterisation and analysis is required to assess their properties and suitability. Bioartificial organs or transplantable microdevices must also account for immunogenic considerations, which will be discussed in detail. One of the most characterized cases is the investigation into a bioartificial pancreas, including using microencapsulation of islets or other cells, and will be the focus subject of this review. Overall, this review will discuss the traditional and modern technologies which are necessary for the characterisation of properties for transplantable microdevices or organs, summarizing analysis of the microcapsule itself, cells and finally a working organ. Furthermore, immunogenic considerations of such organs are another important aspect which is addressed within this review. The various techniques, methodologies, advantages, and disadvantages will all be discussed. Hence, the purpose of this review is providing an updated examination of all processes for the analysis of a working, biocompatible artificial organ.

Advanced Polymers for Three-Dimensional (3D) Organ Bioprinting

Three-dimensional (3D) organ bioprinting is an attractive scientific area with huge commercial profit, which could solve all the serious bottleneck problems for allograft transplantation, high-throughput drug screening, and pathological analysis. Integrating multiple heterogeneous adult cell types and/or stem cells along with other biomaterials (e.g., polymers, bioactive agents, or biomolecules) to make 3D constructs functional is one of the core issues for 3D bioprinting of bioartificial organs. Both natural and synthetic polymers play essential and ubiquitous roles for hierarchical vascular and neural network formation in 3D printed constructs based on their specific physical, chemical, biological, and physiological properties. In this article, several advanced polymers with excellent biocompatibility, biodegradability, 3D printability, and structural stability are reviewed. The challenges and perspectives of polymers for rapid manufacturing of complex organs, such as the liver, heart, kidney, lung, breast, and brain, are outlined.