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Recombinant DNA Technology and Gene Therapy Using Viruses
Published in Patricia G. Melloy, Viruses and Society, 2023
Recombinant DNA technology, also known as genetic engineering, is the idea that a gene or stretch of DNA from one biological source can be transferred to another source where it can be expressed in that new organism (Alberts et al. 2019; Kurreck and Stein 2016; Mukherjee 2016; Colavito 2007; Minkoff and Baker 2004). The transfer of genetic material into the new organism is a kind of genetic modification, resulting in a genetically modified organism (LabXChange 2022). The genetically modified organism (GMO) can also be called a transgenic organism, meaning that it is an organism containing a transgene or newly introduced gene (Pray 2008).
Immunosuppressants, rheumatic and gastrointestinal topics
Published in Evelyne Jacqz-Aigrain, Imti Choonara, Paediatric Clinical Pharmacology, 2021
Evelyne Jacqz-Aigrain, Imti Choonara
Insulin was first isolated from the dog’s pancreata by Banting and Macleod. The first patient to receive the extract, in January 1922 at the Toronto General Hospital, with immediate success, was Leonard Thomson; a 14-year-old boy with diabetes. Early insulins were derived from pig and cow pancreata; modified by the addition of protamine to delay absorption and prolong the action of insulin preparations. Subsequently, recombinant DNA technology has allowed the production of insulin identical to human insulin from recombinant strains of Escherichia coli and yeast, and animal insulins are now rarely used.
Epilogue
Published in Brendan Curran, A Terrible Beauty is Born, 2020
However, most people would probably agree that recombinant DNA technology should be used, where possible, to help close the gap between the richest and poorest countries. A fifth of the world’s population already owns 80% of its wealth; how can we redress the balance? If large scale famine is to be avoided, food production must increase by 40–50% by the year 2020 while using a smaller land area for cultivation. Given that most of this additional food will be needed in developing countries, should it be produced there or in developed countries, where agricultural efficiency is so much greater? How can we best introduce the benefits of genetic technology to the poorer countries with both limited resources and limited traditions for using all new forms of technology? International agencies are already struggling to deal with these problems and many see the transfer of the genetic technologies from the industrial regions as a key to this drama. It will happen only if the political will (ultimately the will of the public at large) is there and will be effective only if the recipients are properly trained.
The Promise and Reality of Public Engagement in the Governance of Human Genome Editing Research
Published in The American Journal of Bioethics, 2023
John M. Conley, R. Jean Cadigan, Arlene M. Davis, Eric T. Juengst, Kriste Kuczynski, Rami Major, Hayley Stancil, Julio Villa-Palomino, Margaret Waltz, Gail E. Henderson
Genome editing is a vital research tool with broad applications to human disease. Its significance and novelty raise many questions about governance and policy, including who should determine the ethical boundaries of its use. In 1975, confronted with the challenges of writing safety guidelines for recombinant DNA technology, the government and public deferred to the authoritative judgment of scientists (Hurlbut 2015). This expert-driven, technocratic model of regulation (Blasimme 2019) has been gradually undermined by the new CRISPR-Cas9 technology, which has enabled the proliferation of human genome editing possibilities. In what may have been a turning point, the He Jiankui experiments with CRISPR-edited babies were described by Nobel laureate David Baltimore as a “failure in self-regulation by the scientific community” (Normile 2018). As part of a broader critique of top-down approaches, commissions, NGOs, academic commentators, and others considering genome editing research have nearly universally endorsed public engagement (PE) as a desirable, even essential feature of good governance and policymaking.
Culturing human pluripotent stem cells for regenerative medicine
Published in Expert Opinion on Biological Therapy, 2023
Hiroki Ozawa, Takuya Matsumoto, Masato Nakagawa
ISO20399:2022 sets out the requirements and recommendations for both suppliers and users of AMs to ensure the safety and performance of manufactured cell products [43]. Moreover, there are variations in the emphasis placed on relevant guidelines and regulations among different countries [49]. For example, USP1043 guides the development of appropriate qualification programs for AMs used in cell, gene, and tissue-engineered products in the US [46]. In contrast, the EU EP5.2.12 focuses on materials extracted from biological sources and/or produced by recombinant DNA technology and addresses risk assessment, manufacturing, and quality control [50]. Japan has established the Standards for Biological Ingredients (SBIs) to ensure the safety of cell transplants and other products. These guidelines regulate using raw materials, animals, plants, and microorganisms and their products in pharmaceuticals, cosmetics, and foods. For example, fetal bovine serum (FBS) used in cell culture must follow these guidelines. Medical applications of hPSCs must also comply with these guidelines to ensure product quality and safety [51].
Immunotoxins and nanobody-based immunotoxins: review and update
Published in Journal of Drug Targeting, 2021
Mohammad Reza Khirehgesh, Jafar Sharifi, Fatemeh Safari, Bahman Akbari
ITs are new tools for cancer therapy that consists of two functional components: targeting and cytotoxic moieties. In ITs design, the binding domain of the protein toxin, responsible for binding to a specific receptor, replaces with a targeting moiety, usually mAbs [17]. Therefore, non-protein toxins such as Brevetoxin B [11,25–27] and Aflatoxins [28,29] did not use in ITs construction. Up to now, four generations of ITs produced via four different approaches. The first generation of IT has been developed by attaching the native toxin to full-length mAbs through chemical methods. The ITs had some problems such as low specificity and stability, heterogeneity, reactivity to normal cells, and immunogenicity. Due to these problems, the second generation of IT has been developed. In this generation, the modified toxin, without the natural binding domain, chemically bonded to full-length mAbs. Although the specificity increased, other problems remained [11,30,31]. Third-generation produced by recombinant DNA technology. In this generation, the truncated toxins, without the natural receptor-binding domain, linked to antibody fragments by the peptide linker that led to developing recombinant ITs (RITs) [32,33]. For immunogenicity reduction of RITs, fourth-generation was developed using humanised or fully human formats of antibodies and endogenous proteins of human origin [34,35]. Numerous clinical trials and the US Food and Drug Administration (FDA) approvals indicate the promising IT landscape in cancer treatment (Table 1).