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5 Engineering Targeted and Accessible Medicine
Pages 117-150

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From page 117...
...  The development of disease treatments is a multidisciplinary enterprise, and chem ical engineers can contribute to many aspects of medicine by applying systems biology to physiology, the discovery and development of molecules and materials, and process development and scale-up.  Many health disparities are a result of systemic issues that will require larger social changes to address, but chemical engineers can develop engineering solutions that help address disparities requiring more focused efforts.
From page 118...
... Following an overview of the role of biomolecular engineering in health and medicine, the chapter describes opportunities for chemical engineers to advance personalized medicine; improve therapeutics; understand the microbiome; design materials, devices, and delivery mechanisms; and develop hygiene technologies. Finally, the chapter examines how chemical engineers can contribute to addressing health disparities that result from societal inequity and reducing the costs of therapeutic treatments.
From page 119...
... Since the first attempts to produce small molecules from biological organisms, the development of biologically derived products has increased. As described in Box 2-2 in Chapter 2, biochemical and biomolecular engineering and production of medicines have continued to grow, with major advances resulting from the development of recombinant DNA technology, the sequencing of genomes, the development of polymerase chain reaction (PCR)
From page 120...
... NOTE: CHO = Chinese hamster ovary; CRISPR = clustered regularly interspaced short palindromic repeats; ESC = embryonic stem cell; FDA = U.S. Food and Drug Administration; MS = multiple sclerosis; PCR = polymerase chain reaction; RNAi = RNA interference; TALENs = transcription activator-like effector nucleases; ZFNs = zinc-finger nucleases.
From page 121...
... However, the repercussions of the pandemic also serve as a reminder of the importance of the availability and transport of raw materials, as well as the critical importance of scale-up of manufacturing where medicines are needed and the fact that even in higher-income countries, health disparities can result in needless deaths. The next 20 years of chemical and biomolecular engineering will feature opportunities in personalized medicine; advances in the engineering of biologic molecules, including proteins, nucleic acids, and such entities as viruses and cells; growth at the interface between materials and devices and health; the use of tools from systems and synthetic biology to understand biological networks and their intersections with data science and machine learning; development of the next steps in manufacturing; and the use of engineering approaches to address health equity and access to health care.
From page 122...
... For lowdose or limited-duration drugs for which limited scale-up data are available, Bayesian statistics are used to estimate acceptable parameter ranges and product specifications. Translational medicine bioinformatics is an emerging field that draws on the fundamentals of chemical engineering and has the potential to transform personalized medicine.
From page 123...
... Cell-Based Therapies Another aspect of personalized medicine is cell-based therapies -- most important, CAR (chimeric antigen receptor) T cell immunotherapy.
From page 124...
... Computational Tools and Modeling to Improve Personalized Medicine Systems biology applied to physiology is an additional avenue for chemical engineers to contribute to personalized medicine. As early as the 1960s, Yeats and Urquhart (1962)
From page 125...
... . Other means of patient-state monitoring might include the design of nanoparticle or microparticle probes targeting specific cell types so they can be tracked and monitored over extended time periods.
From page 126...
... Fortunately, Moderna had already gained experience in this area and built a manufacturing facility for the development of other vaccines that were approaching early clinical trials. Protein-based biologic drugs have been manufactured using cell-based bioreactors to generate proteins for therapeutics, and a significant amount of biotechnology know-how is based on the engineering of bioreactors that require management of titers from microbes or mammalian cells, management of cell viability and oxygen and nutrient levels, and extensive removal of cellular debris and waste products as part of the purification process.
From page 127...
... At the time that the SARS-CoV-2 virus appeared, Moderna had 10 other mRNAbased drugs approved by the FDA as Investigational New Drugs or for clinical trials, and had already launched a manufacturing facility for mRNA vaccines that were in various phases of clinical trial. Because the manufacturing machinery was already in place, the company was able to take full advantage of the highly versatile and modular nature of an mRNA vaccine, along with a significant funding stimulus from the U.S.
From page 128...
... CRISPR (clustered regularly interspaced short palindromic repeats) , synthetic biology, chimeric antigen receptor (CAR)
From page 129...
... Because subunit vaccines are smaller biomolecular units, they also provide a more accessible route to creating manufacturing platforms that allow rapid vaccine development and scalable on-site manufacturing. An interesting biological engineering consideration is the selection of biological hosts for the manufacturing process.
From page 130...
... These forms allow for more direct incorporation of a much smaller binding molecule, thus providing molecules that do not require the complex manufacturing steps needed to produce whole antibodies. Protein engineering of these molecules has led to exciting therapeutic opportunities -- the combination of Fab components from two different antibodies can yield bispecific antibodies with dual-binding capability, and it is also possible to fuse an antibody with a targeting protein to create a therapy that binds to specific cell types for targeted therapies.
From page 131...
... MODELING AND UNDERSTANDING THE MICROBIOME The complexity of the microbiome -- which includes multiple cell types involved in both the microbial community of a given organ and the different host cells that support and respond to that community -- presents a challenge for modeling of host–microbiome interactions to develop predictive solutions for human health (Box 5-3)
From page 132...
... Furthermore, synthetic biology tools have made it possible to directly modify bacteria to create new therapeutic approaches for addressing a range of chronic disorders or enabling settings with greater resistance to infections or susceptibility to disease. The advancement of these methods in metabolic engineering in general has opened up many opportunities to apply them to understanding the microbiome.
From page 133...
... . The gut microbiome is the most studied microbiome of the human body, and significant progress has been made toward building databases that will inform GEM models, as well as other computational approaches, particularly machine learning and artificial intelligence methods that require large datasets.
From page 134...
... Synthetic Biology as a Tool for Engineering Microbes to Improve Microbiome Health Bacteria have unique qualities that can be manipulated to enable the generation of synthetic microbiota with programmed function. In conjunction with gene editing tools, this work can yield a wide range of functions that depend on communication and interaction with other cell types.
From page 135...
... . Given recent findings regarding the gut microbiome–neurological connection and the likely advances in biological understanding of both the gut and other human microbiome communities with respect to disease and overall human health, this area of technology is likely to expand significantly in the next decade.
From page 136...
... The unique skillsets of chemical engineers can contribute to gaining knowledge, enabling discovery, addressing disease, and enhancing human health through understanding and regulation of the human microbiome. Key challenges and opportunities include further advancement of synthetic biology tools that incorporate environmental and conditional responses, regulation of the reactome across multiple species, and engineering of cellular consortia to achieve patient-specific outcomes.
From page 137...
... The development of such devices requires novel formulation strategies, pump designs, control algorithms, and continuous sensors, challenges for which chemical engineers are well suited. Another exciting frontier for chemical engineering is the development of devices for completely noninvasive methods of drug delivery.
From page 138...
... This limitation ultimately reflects the high cost and lengthy timeframes of drug development. FIGURE 5-7 Examples of biomaterials and their routes of administration for in vivo use.
From page 139...
... Moving forward, opportunities for chemical engineers in the field of drug delivery include developing a better understanding of transport processes and leveraging this understanding to accomplish better targeting. One of the key challenges is the limited spatial and temporal resolution of drug imaging in the body.
From page 140...
... By virtue of their training in understanding and appreciating multiscale dynamics, chemical engineers are especially well suited to undertaking this challenge. Personalization of drug therapies is an exciting opportunity to reduce adverse events without compromising therapeutic efficacy.
From page 141...
... Tools to minimize the burden of preclinical drug development will not only reduce the cost and time of development and provide preclinical information that is more relevant to clinical programs, but also level the playing field for drug developers. Several advances have been and continue to be achieved in the development of scaled-down microphysiological systems (the so-called organ-on-a-chip or human-bodyon-a-chip)
From page 142...
... Hepatotoxicity is a key safety concern for many drugs, and a means of screening for it at an earlier stage could substantially accelerate drug development. Liver chips could also help screen nanomedicines, which are actively cleared by the liver after their administration to the body.
From page 143...
... . From their fundamental understanding of fluid mechanics, chemical engineers can readily confirm the time scale (many hours)
From page 144...
... took the analysis of aerosol size distribution in another useful direction -- variation within the population as a function of several factors, including COVID-19 infection, age, and body mass index. They showed that all three of these factors can influence aerosol sizes by three orders of magnitude, and thus serve as a useful starting point for estimating of spreading distances and infection transmission rates.
From page 145...
... ENGINEERING SOLUTIONS FOR ACCESSIBILITY AND EQUITY IN HEALTH CARE NIH defines health disparities as differences among specific population groups in the attainment of full health potential that can be measured by differences in incidence, prevalence, mortality, burden of disease, and other adverse health indicators. While the term "disparities" is often used or interpreted to reflect differences among racial or ethnic groups, disparities can exist across many other dimensions as well, such as gender, sexual orientation, age, disability status, socioeconomic status, and geographic location (NASEM, 2017)
From page 146...
... Essential ethical considerations include the impact of new technologies or processes on low-resource communities and marginalized populations who experience greater health disparities, including how new treatments or technologies will be received among different cultures and populations and the impact on the environment. Chemical engineers have an opportunity to help reduce health disparities when they explicitly incorporate human-centered design into technologies to make them more accessible, equitable, and culturally sensitive.
From page 147...
... . In addition, supply chain issues, such as quality and consistency of raw material, become even more important with a perfusion approach to minimize product variance.
From page 148...
... Current challenges for applications in health and medicine include advancing personalized medicine and the engineering of biological molecules, including proteins, nucleic acids, and other entities such as viruses and cells; bridging the interface between materials and devices and health; improving the use of tools from systems and synthetic biology to understand biological networks and the intersections with data science and machine learning; developing the next steps in manufacturing; and using engineering approaches to address equity and access to health care. All of these challenges present opportunities for chemical engineers to apply systems-level approaches and their ability to work across
From page 149...
... Furthermore, increased diversity of both students and instructors in the classroom will provide a broader perspective on the challenges requiring engineering solutions. Recommendation 5-1: Federal research investments in biomolecular engineering should be directed to fundamental research to  advance personalized medicine and the engineering of biological mole cules, including proteins, nucleic acids, and other entities such as viruses and cells;  bridge the interface between materials and devices and health;  improve the use of tools from systems and synthetic biology to under stand biological networks and the intersections with data science and computational approaches; and  develop engineering approaches to reduce costs and improve equity and access to health care.
From page 150...
... 150 New Directions for Chemical Engineering Recommendation 5-2: Researchers in academic and government laboratories and industry practitioners should form interdisciplinary, cross-sector collaborations to develop pilot- and demonstration-scale projects in advanced pharmaceutical manufacturing processes.


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