ABSTRACT
Under the background of major innovations and changes in international pharmaceutical technology, the continuous development of informatization and digitalization of drug R & D, technology, and the COVID-19 pandemic, the European Commission (EC) issued the pharmaceutical Strategy for Europe (PSE) at the end of 2020 in order to meet the unfinished clinical needs, stimulate industry innovation, enhance the adaptability of the regulatory system, and consolidate the international status of the EC drug regulatory system. PSE is regarded as the "cornerstone" of European health policy in the next five years, which has important guiding significance for the development and management of European pharmaceutical industry. This paper combs and analyzes the background, development strategic objectives and specific measures of PSE, and puts forward policy suggestions in combination with the actual work of China's epidemic prevention and control and industry development, pharmaceutical scientific supervision and encouraging innovation.Copyright © 2022 by the Author(s).
ABSTRACT
Delivery of self-amplifying mRNA (SAM) has high potential for infectious disease vaccination due to its self-adjuvanting and dose-sparing properties. Yet a challenge is the susceptibility of SAM to degradation and the need for SAM to reach the cytosol fully intact to enable self-amplification. Lipid nanoparticles are successfully deployed at incredible speed for mRNA vaccination, but aspects such as cold storage, manufacturing, efficiency of delivery, and the therapeutic window can benefit from further improvement. To investigate alternatives to lipid nanoparticles, a class of >200 biodegradable end-capped lipophilic poly(beta-amino ester)s (PBAEs) that enable efficient delivery of SAM in vitro and in vivo as assessed by measuring expression of SAM encoding reporter proteins is developed. The ability of these polymers to deliver SAM intramuscularly in mice is evaluated, and a polymer-based formulation that yields up to 37-fold higher intramuscular (IM) expression of SAM compared to injected naked SAM is identified. Using the same nanoparticle formulation to deliver a SAM encoding rabies virus glycoprotein, the vaccine elicits superior immunogenicity compared to naked SAM delivery, leading to seroconversion in mice at low RNA injection doses. These biodegradable nanomaterials may be useful in the development of next-generation RNA vaccines for infectious diseases.Copyright © 2023 The Authors. Advanced Therapeutics published by Wiley-VCH GmbH.
ABSTRACT
Recent advancements in nanotechnology have resulted in improved medicine delivery to the target site. Nanosponges are three-dimensional drug delivery systems that are nanoscale in size and created by cross-linking polymers. The introduction of Nanosponges has been a significant step toward overcoming issues such as drug toxicity, low bioavailability, and predictable medication release. Using a new way of nanotechnology, nanosponges, which are porous with small sponges (below one microm) flowing throughout the body, have demonstrated excellent results in delivering drugs. As a result, they reach the target place, attach to the skin's surface, and slowly release the medicine. Nanosponges can be used to encapsulate a wide range of medicines, including both hydrophilic and lipophilic pharmaceuticals. The medication delivery method using nanosponges is one of the most promising fields in pharmacy. It can be used as a biocatalyst carrier for vaccines, antibodies, enzymes, and proteins to be released. The existing study enlightens on the preparation method, evaluation, and prospective application in a medication delivery system and also focuses on patents filed in the field of nanosponges.Copyright © 2023 The Authors.
ABSTRACT
Adenovirus vectors have been employed to develop a vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for curtailing the Covid-19 pandemic spreading. Many different viral vectors have been mainly targeting the SARS-CoV-2 spike (S) protein as an antigen. Spike (S) protein is comprised of S1 and S2 subunits, in which the receptor-binding domain (RBD) of S1 is responsible for recognizing and engaging with its host cellular receptor protein angiotensin-converting enzyme 2 (ACE2), S2 accounts for membrane fusion of virus and host cell. Chimpanzee adenovirus was also used as a vector vaccine for SARS-CoV-2 (ChAdSARS-CoV-2-S) by intramuscular injection, and intranasal administration has been tested. Adenovirus vector-based vaccines are the most advanced, with several vaccines receiving Emergency Use Authorization (EUA). It was shown that rhesus macaques were protected from SARS-CoV-2 challenge after a month of being vaccinated with ChAd-SARS-CoV-2-S. A single intranasal or two intramuscular ChAd-SARSCoV-2-S vaccines could induce humoral antibodies and T cell responses to protect the upper and lower respiratory tract against SARS-CoV-2. As the effectiveness was demonstrated in non-human primates, ChAd-SARS-CoV-2-Sa potential option for preventing SARS-CoV-2 infection in humans. However, detecting novel more transmissible and pathogenic SARS-CoV-2 variants added concerns about the vaccine efficacy and needs monitoring. Moreover, the cause of recently documented rare cases of vaccine indicated immune thrombotic thrombocytopenia. This review article provided details for the adenovirus vector vaccine for SARS-CoV-2 in humans and tried to provide solutions to the adenovirus vector hemagglutinin issueCopyright © 2023, World's Veterinary Journal.All Rights Reserved.
ABSTRACT
Vaccine development usually takes around 7 y to come to the market after getting necessary regulatory approvals. But recent pandemics like Covid, Ebola, Swine Flu, have resulted in the collaboration of efforts between the government doing investments in vaccine development, academia, regulatory bodies, and industry. This has shortened the timelines for approval for vaccines. In 2009, HINI, Swine flu vaccines took 93 d for identifying the vaccine candidate for clinical trials. In 2014, for Ebola vaccine, it was deployed while the epidemic was still going on. Ebola vaccine was developed in 5 y. In case of Covid (SARS-CoV-2) clinical trials were approved when 2 mo of the pandemic onset. Within a time of 9 mo about 138 vaccine candidates are being reviewed for approval of EUA. This highly helps in the shortening of vaccine development and necessary approval. In this paper, we focused on the regulatory framework of vaccine development in INDIA, US and EU.Copyright © 2023 The Authors.
ABSTRACT
Over the past decade, compared to all other macromolecules lipid-based nanocarriers have proven to be an excellent carrier and delivery system for various pharmaceutical drugs of poor bioavailability. In addition to that, they exhibit exceptional qualities such as minimal toxicity, economical scale-up production, great biocompatibility, and high drug loading efficiency. In this study, we have discussed the various types of lipid nanoparticles, such as liposomes, nanostructured lipid carriers, solid lipid nanoparticles, and lipid polymer hybrid nanoparticles. We have also conferred in detail, the composition, shape and size, methods of preparation, advantages, and certain limitations associated with these lipid-based nanocarriers. Additionally, we have exclusively accounted for several examples of lipid-based nanomedicines that have either been approved and commercialized or are under the different phases of clinical trials. The current review overall focuses on the up-to-date research that has recently been published in view of developing lipid-based nanocarriers for various biological applications, including gene therapy, breast cancer therapy, and vaccine development.Copyright © 2022
ABSTRACT
It has been proven that mRNA vaccines are highly effective against the COVID-19 outbreak, and low prevalence of side effects has been shown. However, there are still many gaps in our understanding of the biology and biosafety of nucleic acids as components of lipid nanoparticles (LNPs) most often used as a system for inctracellular delivery of mRNA-based vaccines. It is known that LNPs cause severe injection site inflammation, have broad biodistribution profiles, and are found in multiple tissues of the body, including the brain, after administration. The role of new medications with such pharmacokinetics in inflammation developing in inaccessible organs is poorly understood. The study was aimed to assess the effects of various doses of mRNA-LNP expressing the reporter protein (0, 5, 10, and 20 microg of mRNA encoding the firefly luciferase) on the expression of neuroinflammation markers (Tnfalpha, Il1beta, Gfap, Aif1) in the prefrontal cortex and hypothalamus of laboratory animals 4, 8, and 30 h after the intramuscular injection of LNP nanoemulsion. It was shown that mRNA-LNP vaccines in a dose of 10-20 microg of mRNA could enhance Aif1 expression in the hypothalamus 8 h after vaccination, however, no such differences were observed after 30 h. It was found that the Gfap, l11beta, Tnfalpha expression levels in the hypothalamus observed at different times in the experimental groups were different. According to the results, mRNA-LNPs administered by the parenteral route can stimulate temporary activation of microglia in certain time intervals in the dose-dependent and site specific manner.Copyright © 2022 Pirogov Russian National Research Medical University. All rights reserved.
ABSTRACT
Despite the development of new antigens and adjuvants in conventional vaccine studies, different approaches are required in vaccine formulations due to the poor immunogenicity, in vivo intrinsic instability, toxicity, and the need for multiple administrations of conventional vaccines. To overcome these problems, nanotechnology approaches have recently been incorporated into vaccine formulations. As the development of vaccines is directed towards "minimal" compositions with low immunogenicity, there is an increasing need for new formulations that enhance the efficacy of antigens and adjuvants. There is an urgent need to regulate existing advanced treatment options for the global health threat posed by COVID-19, as well as to accelerate the development of new vaccines and drugs. Nano-sized carrier systems developed for the diagnosis and treatment of many diseases, especially cancer, continue to maintain their importance in the COVID-19 pandemic. The use of nanoparticles in medicine started about 30 years ago, but gained momentum with the pandemic and reached many people in a short time with vaccine formulation. The rapid development, approval and delivery of SARS-CoV-2 vaccines is one of the most important achievements in the history of medicine, and nanomedicine is part of that history. Within the scope of the review, up-to-date information was given about the use of nanotechnology and nanoparticles in COVID-19 vaccine development studies.Copyright © Telif Hakki 2022 Flora.
ABSTRACT
This is a brief overview on student engagement and perception of remote practical activities during the COVID-19 outbreak emergency. The topics that were heavily affected by these sudden and unexpected changes, where chemistry, biochemistry, bioinformatics, pharmacology, and compounding. This survey took responses from the students of both bachelor and master's degrees at the School of Pharmacy of the University of Milan. This University is in the epicentre of the COVID-19 outbreak in Italy. Despite a good or high appreciation of the online practical activities, up to 95% of participants agreed that multimedia content cannot efficiently replace inperson labs. Moreover, discussions with the teachers and discussions among lab mates has a great positive impact on the knowledge and skills they acquire. Copyright © 2020, International Pharmaceutical Federation. All rights reserved.
ABSTRACT
A vaccine is a material administered to an individual to boost their immune system's resistance against infection. Diseases that can be prevented by vaccination can be controlled and eradicated with proper vaccine handling and storage. It is crucial to formulate and deliver stable, effective and safe vaccines. Since vaccines are intricate biological products so any kind of temperature fluctuation can result in reduction of their effectiveness. To prevent this, cold storage facility is set up;refrigerators, thermometers and storage protocols are in place. The main vaccines distributed for COVID in India are Covishield and Covaxin. In order to maintain a cold chain supply for these vaccines, they must be transported and stored at a regulated temperature in accordance with the manufacturer's guidelines. The end-to-end supply chain for COVID-19 vaccines must adhere to specific cold chain standards from manufacturing to distribution in warehouses and healthcare facilities. Audits for cold chains and temperature monitoring should be performed regularly on the vaccine lots to ensure proper distribution practices are adhered. The present study focuses on the good distribution practice and storage of vaccines. Copyright © 2022 Wolters Kluwer Medknow Publications. All rights reserved.
ABSTRACT
Since 2019, the coronavirus disease (COVID-19) has caused 6,319,395 deaths worldwide. Although the COVID-19 vaccine is currently available, the latest variant of the virus, Omicron, spreads more easily than earlier strains, and its mortality rate is still high in patients with chronic diseases, especially cancer patients. So, identifying a novel compound for COVID-19 treatment could help reduce the lethal rate of the viral infection in patients with cancer. This study applied network pharmacology and systematic bioinformatics analysis to determine the possible use of curcumol for treating colon adenocarcinoma (COAD) in patients infected with COVID-19. Our results showed that COVID-19 and COAD in patients shared a cluster of genes commonly deregulated by curcumol. The clinical pathological analyses demonstrated that the expression of gamma-aminobutyric acid receptor subunit delta (GABRD) was associated with the patients' hazard ratio. More importantly, the high expression of GABRD was associated with poor survival rates and the late stages of COAD in patients. The network pharmacology result identified seven-core targets, including solute carrier family 6 member 3, gamma-aminobutyric acid receptor subunit pi, butyrylcholinesterase, cytochrome P450 3A4, 17-beta-hydroxysteroid dehydrogenase type 2, progesterone receptor, and GABRD of curcumol for treating patients with COVID-19 and COAD. The bioinformatic analysis further highlighted their importance in the biological processes and molecular functions in gland development, inflammation, retinol, and steroid metabolism. The findings of this study suggest that curcumol could be an alternative compound for treating patients with COVID-19 and COAD.