194 research outputs found
Exosomes nanovesicles for gene delivery and vaccination
No full textThis chapter delves into the growing field of utilizing exosomes as nanocarriers for gene and vaccine delivery. Commencing with an examination of the fundamental characteristics of exosomes, such as cellular targeting, stability, and immunomodulatory properties, the narrative traverses the intricate landscape of engineering strategies employed for payload loading and improved delivery. Subsequently, it elucidates the latest reports on using exosomes for gene delivery, demonstrating their efficacy in transporting mRNA, siRNA/miRNA, and even CRISPR-Cas9 for precise therapeutic interventions. Furthermore, the chapter delves into the application of exosomes in vaccination, shedding light on their interactions with the immune system and inherent immunomodulatory features. The current clinical status of exosome-based platforms and the existing challenges are also meticulously examined. In summary, this chapter furnishes a comprehensive overview of exosome-based gene and vaccine delivery platforms, emphasizing their potential to catalyze transformative advancements in biomedical research and clinical practice.</p
Bioengineering and modification of exosome nanovesicles for targeted drug delivery
No full textExosomes hold immense promise as drug delivery vehicles owing to their innate cargo transport capabilities and minimal immunogenicity. This manuscript explores strategies for augmenting their therapeutic efficacy, focusing on genetic and chemical modifications, membrane fusion, and biomimetic coatings to achieve targeted drug delivery. By encapsulating therapeutics like small molecules or nucleic acids, exosomes can be tailored to deliver payloads to specific cell types or tissues, optimizing therapeutic outcomes. Drawing insights from pre-clinical studies, we showcase the diverse applications of modified exosomes across fields such as cancer therapy, regenerative medicine, wound healing, and inflammatory and infectious diseases. Furthermore, we address current challenges impeding clinical translation and propose potential solutions. This comprehensive guide offers researchers and practitioners a roadmap for navigating the intricacies and potentials of engineered exosomes in targeted drug delivery.</p
Exosomes for protein and peptide drug delivery
No full textExosomes, the smallest extracellular vesicles, are emerging as powerful vehicles for the targeted delivery of protein and peptide therapeutics. Originating from endosomal compartments, these vesicles excel in intercellular communication and can transport a variety of biological molecules, making them highly suitable for therapeutic use. This chapter focuses on the utilization of exosomes for delivering proteins and peptides, exploring their biogenesis, and detailing methods such as incubation, electroporation, and sonication for loading these therapeutic agents. Key studies illustrate the successful application of exosomes in crossing biological barriers, such as the blood-brain barrier, to deliver targeted treatments for diseases including cancer and inflammatory conditions. Despite challenges like the heterogeneity of exosomes and difficulties in their isolation and purification, the chapter highlights strategies to overcome these obstacles and enhance protein/peptide efficiency. Emphasizing the potential of exosomes to revolutionize protein and peptide delivery systems, this chapter provides insights into future directions that could further harness their clinical applications, demonstrating their pivotal role in advancing therapeutic strategies.</p
Regulatory processes involved in clinical trials and intellectual property rights around vaccine development
No full textThis chapter explores the critical intersection of regulatory processes and intellectual property rights (IPR) within the context of vaccine development. With the ongoing global focus on public health and the urgent need for effective vaccines, understanding the intricate regulatory frameworks and IPR landscape becomes vital for stakeholders in the pharmaceutical and biotechnology industries. The chapter begins by providing a comprehensive overview of the regulatory processes governing clinical trials, delving into the various stages, including preclinical testing, investigational new drug applications, and the distinct phases of human clinical trials. The ethical considerations inherent in clinical research and the importance of adherence to regulatory guidelines are emphasized. Moreover, the chapter examines the roles and responsibilities of regulatory bodies involved, such as the Food and Drug Administration in the United States, the European Medicines Agency in Europe, and other regional authorities. Furthermore, this chapter explores the intricate relationship between vaccine development and IPR. It examines the impact of IPR on vaccine accessibility, including potential monopolies, high prices, and implications for global health equity. The protection of intellectual property rights, such as patents, trademarks, and licensing agreements, is discussed in detail. Strategies for balancing IPR protection with the need for affordable and accessible vaccines are explored, including technology transfer, compulsory licensing, and patent pooling. The global regulatory frameworks governing clinical trials are also addressed, focusing on international guidelines, harmonization efforts, and regional challenges. The chapter examines regulatory approval processes, postmarketing surveillance, and expedited pathways for vaccine development, including emergency use authorization. Lastly, the chapter delves into the practical aspects of clinical trial management, encompassing site selection, regulatory submissions, monitoring, safety reporting, data management, and trial completion. This chapter provides a comprehensive analysis of the regulatory processes involved in clinical trials and their interaction with IPR in the context of vaccine development. It serves as a valuable resource for researchers, policymakers, and industry professionals seeking a deeper understanding of the complex dynamics surrounding vaccine regulation and intellectual property.<br/
Plant-based vaccines for emerging infectious diseases
No full textUnderstanding the relationship of infectious materials with host immunity, along with the importance of faulty immune function in the progression of the disease, would be instrumental in explaining infectious pathogenicity, predisposing factors for the worst outcome, and the rational design of therapeutic interventions and immunization. There is a rising need for defended, improved, and effectual vaccine candidates against emerging infectious diseases in various components of the world. Plant-derived vaccines are primarily based on the protein components of infectious viruses. However, some vaccine candidates also use a unique pathogen target, such as the N protein. Tobacco plants have been used to create virus-like particles (VLPs), chimeric VLPs, protein subunit vaccines, and carrier molecule-fused protein subunit vaccines. The plant-based manufacturing process could meet a portion of the world's vaccine demand. In this review, an attempt is made to summarize the state-of-the-art plant-derived vaccine rostrum for infectious diseases that are in the clinical development stage and have demonstrated favorable results with reference to effectiveness and security.<br/
Vaccine safety, efficacy, and ethical considerations
No full textVaccines play a crucial role in preventing and regulating the spread of infectious agents in the face of new infectious diseases and global health threats. This chapter seeks to provide an up-to-date comprehension of the field by examining the most important aspects of vaccine safety, efficacy, and ethical concerns. Vaccine safety is critical for maintaining public trust and confidence. Extensive preclinical and clinical investigations evaluate vaccination safety profiles, examining possible side effects and determining the risk-benefit ratio. Surveillance systems are critical for identifying and managing possible adverse events during postlicensure monitoring. Vaccine safety monitoring is a continuous procedure that strives to raise the safety profile and resolve public concerns. Every step of the vaccine life cycle requires careful consideration of ethics. With a focus on at-risk groups and the advancement of global health equality, ethical frameworks guide the equitable distribution of vaccines. Transparency, autonomy respect, and informed consent are fundamental ethical concepts in vaccination research and communication. To further combat vaccine skepticism, it is crucial to involve the community, dispel myths, and educate the public to achieve broad vaccine adoption. Successful vaccination programs balance safety, efficacy, and ethics. Vaccine reluctance, equitable distribution, and limited resources require worldwide collaboration and coordinated efforts. Vaccine safety surveillance, vaccine development, and ethical frameworks are important steps ahead. We emphasize vaccine safety, efficacy, and ethics in public health. By addressing these critical variables, we can develop effective vaccination programs that protect individuals and populations from infectious diseases while honoring ethical values and retaining public confidence in vaccines.<br/
Challenges in exosome nanovesicle-based drug delivery and diagnostics
No full textExosomes are small extracellular vesicles ranging from 30 to 150nm in diameter. They facilitate intricate cell-to-cell communication and reflect the physiological and pathological states of their originating cells. This capability positions them as ideal candidates for noninvasive diagnostic tools and targeted drug delivery systems. Exosomes can be engineered to enhance their natural propensity for tissue targeting, potentially transforming the delivery of therapeutics by protecting drugs from enzymatic degradation and minimizing immune reactions. Additionally, their role in conveying molecular information offers a window into cellular functions, enabling early disease detection and monitoring through liquid biopsies. However, the clinical translation and commercialization of exosome-based applications face significant challenges. These include the scalability of production methods, the standardization of isolation and purification protocols, and the establishment of regulatory frameworks. Addressing these challenges necessitates advancements in technological platforms, cross-disciplinary collaboration, and innovation in regulatory strategies. This manuscript comprehensively explores these challenges and outlines potential pathways forward, emphasizing the need for a coordinated effort to harness the clinical benefits of exosomes in medicine.</p
Parenteral vaccine delivery: From basic principles to new developments
No full textParenteral administration of vaccines has been a highly effective strategy for preventing and controlling infectious diseases. Parenteral vaccines are administered through routes other than the gastrointestinal tract, such as intramuscular, subcutaneous, or intradermal injections. These routes offer several advantages, including the rapid and efficient delivery of antigens to the immune system, induction of robust immune responses, and enhanced vaccine stability. Moreover, parenteral vaccines can be formulated with adjuvants to further enhance their immunogenicity. Recent advancements in parenteral vaccine development have focused on several key areas. First, there has been significant progress in the design and formulation of novel antigen delivery systems, such as liposomes, virus-like particles, and nanoparticle-based carriers. These systems offer improved antigen stability, controlled release, and targeted delivery to specific immune cells. Second, advances in recombinant DNA technology have enabled the production of highly purified and well-characterized antigens, improving the safety and efficacy of parenteral vaccines. Third, the development of novel adjuvants, including toll-like receptor agonists and nanoparticle-based adjuvants, has facilitated the modulation of immune responses and the induction of long-lasting immunity. However, parenteral vaccine development also faces several challenges. Vaccine formulation and stability are critical factors, as certain antigens may degrade or lose potency during storage and transportation. Additionally, the choice of adjuvants requires careful consideration, as they need to elicit robust immune responses without causing adverse reactions. Furthermore, the high cost and complex manufacturing processes associated with parenteral vaccines can limit their accessibility, particularly in resource-limited settings. This chapter provides an overview of parenteral vaccine development, highlighting recent advancements and addressing the challenges associated with this approach.<br/
Juniperus oxycedrus L. ssp. Essential Oil Microneedles: A Promising Antimicrobial and Wound Healing Activity
Full text linkThe use of essential oil (EO) in treating infected wounds is still challenging. A lot of effort has been made to make such an application more convenient. Recently, microneedles (MNDs) have been considered as a smart dermal delivery system to overcome the poor absorption and distribution, low bioavailability, and skin penetration of some drugs. The aim of our study is to evaluate the wound healing activity of juniper-EO-loaded MNDs (EO MNDs) against wounds with bacterial and fungal infection. The Polyvinylpyrrolidone (PVP) MNDs were prepared using the gel-filled mold technique and loaded with juniper EO. In vivo models were created and wounds on rats were infected with two clinically isolated bacterial strains Pseudomonas aeruginosa and Staphylococcus aureus. Furthermore, Candida albicans was used to mimic fungal infection and juniper EO MNDs were tested. The obtained results showed an improvement in wound healing which started from the third day after application of the juniper EO MNDs, and at the sixth day post-infection, the treated wounds were significantly smaller than untreated wounds. A complete healing was shown by the 12th day after infection. Furthermore, our cytotoxicity results showed a cytotoxic effect of juniper EO MNDs on epithelial cells, which explained the faster wound healing in rats. Our study showed that juniper EO MNDs represent a novel strategy in EO delivery with minimal invasion. Juniper EO MNDs demonstrated significant antimicrobial activity against both the bacterial strains Pseudomonas aeruginosa and Staphylococcus aureus and against one fungal strain, Candida albicans. Finally, application of juniper EO MNDs exerted promising activity in the treatment and healing of wound infection
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