Journal articles: 'Accelerating vaccine formulation development'

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Ahl, Patrick L., Christopher Mensch, Binghua Hu, et al. "Accelerating Vaccine Formulation Development Using Design of Experiment Stability Studies." Journal of Pharmaceutical Sciences 105, no. 10 (2016): 3046–56. http://dx.doi.org/10.1016/j.xphs.2016.06.014.

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Kim, Jeremiah Y., Matthew G. Rosenberger, Nakisha S. Rutledge, and Aaron P. Esser-Kahn. "Next-Generation Adjuvants: Applying Engineering Methods to Create and Evaluate Novel Immunological Responses." Pharmaceutics 15, no. 6 (2023): 1687. http://dx.doi.org/10.3390/pharmaceutics15061687.

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Adjuvants are a critical component of vaccines. Adjuvants typically target receptors that activate innate immune signaling pathways. Historically, adjuvant development has been laborious and slow, but has begun to accelerate over the past decade. Current adjuvant development consists of screening for an activating molecule, formulating lead molecules with an antigen, and testing this combination in an animal model. There are very few adjuvants approved for use in vaccines, however, as new candidates often fail due to poor clinical efficacy, intolerable side effects, or formulation limitations. Here, we consider new approaches using tools from engineering to improve next-generation adjuvant discovery and development. These approaches will create new immunological outcomes that will be evaluated with novel diagnostic tools. Potential improved immunological outcomes include reduced vaccine reactogenicity, tunable adaptive responses, and enhanced adjuvant delivery. Evaluations of these outcomes can leverage computational approaches to interpret “big data” obtained from experimentation. Applying engineering concepts and solutions will provide alternative perspectives, further accelerating the field of adjuvant discovery.

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Koff, Wayne C. "Accelerating HIV vaccine development." Nature 464, no. 7286 (2010): 161–62. http://dx.doi.org/10.1038/464161a.

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He, Jason. "Accelerating Recombinant Protein Vaccine Development." Genetic Engineering & Biotechnology News 44, no. 1 (2024): 42–44. http://dx.doi.org/10.1089/gen.44.01.13.

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Larkin, Marilynn. "Seth Berkley—Accelerating AIDS vaccine development." Lancet Infectious Diseases 5, no. 1 (2005): 16–19. http://dx.doi.org/10.1016/s1473-3099(04)01249-6.

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Chiu, Christopher. "Novel immunological insights in accelerating RSV vaccine development." Vaccine 35, no. 3 (2017): 459–60. http://dx.doi.org/10.1016/j.vaccine.2016.11.069.

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Roordink, Danielle, Ann Williams, Bernard Fritzell, et al. "The TB vaccine development pathway – An innovative approach to accelerating global TB vaccine development." Tuberculosis 126 (January 2021): 102040. http://dx.doi.org/10.1016/j.tube.2020.102040.

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Koff, W. C., D. R. Burton, P. R. Johnson, et al. "Accelerating Next-Generation Vaccine Development for Global Disease Prevention." Science 340, no. 6136 (2013): 1232910. http://dx.doi.org/10.1126/science.1232910.

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Rahman, Mohammad Arif, and Marjorie Robert-Guroff. "Accelerating HIV vaccine development using non-human primate models." Expert Review of Vaccines 18, no. 1 (2018): 61–73. http://dx.doi.org/10.1080/14760584.2019.1557521.

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Alkaff, Ahmad Husein, Mutiara Saragih, Mochammad Arfin Fardiansyah, and Usman Sumo Friend Tambunan. "Role of Immunoinformatics in Accelerating Epitope-Based Vaccine Development against Dengue Virus." Open Biochemistry Journal 14, no. 1 (2020): 9–18. http://dx.doi.org/10.2174/1874091x02014010009.

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Dengue Fever (DF) has emerged as a significant public health problem of international concern with its high prevalence in the tropic and subtropical regions. Dengue Virus (DENV), which is the cause of DF, consists of four serotypes of antigenically distinct viruses. The immense variation and limited identity similarity at the amino acid level lead to a problematic challenge in the development of an efficacious vaccine. Fortunately, the extensively available immunological data, the advance in antigenic peptide prediction, and the incorporation of molecular docking and dynamics simulation in immunoinformatics have directed the vaccine development towards the rational design of the epitope-based vaccine. Here, we point out the current state of dengue epidemiology and the recent development in vaccine development. Subsequently, we provide a systematic review of our validated method and tools for B- and T-cell epitope prediction as well as the use of molecular docking and dynamics in evaluating epitope affinity and stability in the discovery of a new tetravalent dengue vaccine through computational epitope-based vaccine design.

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Yang, Kairui. "Accelerating Vaccine Development: Plug-and-Play Platforms for Emerging Infectious Diseases." Theoretical and Natural Science 111, no. 1 (2025): 1–9. https://doi.org/10.54254/2753-8818/2025.au22949.

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Emerging pathogens underscore an urgent need for rapidly developed vaccines to minimize mortality and societal disruption. Traditional vaccine development requires time spans of years, making it ill-suited to fast-evolving viruses that can overwhelm healthcare systems and economies. In response, plug-and-play vaccine platforms offer a more agile solution. By reusing proven backbones, they reduce the repetitive safety and production steps otherwise required for each new pathogen, thus accelerating both regulatory approval and large-scale manufacturing. In parallel, artificial intelligence and computational tools enable faster antigen and epitope identification, more accurate immune response modeling, and improved vaccine design. These innovations have already shortened timelines and enhanced efficacy.

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Mansour, Ahd A., Sukalyani Banik, Meenakshi Malik, Alison A. McCormick, and Chandra Shekhar Bakshi. "Development of a Multivalent Subunit Vaccine against Respiratory Tularemia." Journal of Immunology 198, no. 1_Supplement (2017): 147.17. http://dx.doi.org/10.4049/jimmunol.198.supp.147.17.

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Abstract Francisella tularensis (Ft); the causative agent of a fatal human disease tularemia is classified as a Category A Select Agent. No licensed vaccine is available for prevention of tularemia in the U.S.A. In this study, we used a novel Tobacco Mosaic Virus (TMV) based delivery platform for development of a fully protective multi-antigen subunit tularemia vaccine. Previously we have published that a trivalent TMV-conjugate vaccine confers 50% protection in immunized mice against respiratory Ft LVS challenge. In this study, we refined TMV-conjugate vaccine formulation to improve the level of protection in immunized C57BL/6 mice against respiratory tularemia. We developed a tetravalent vaccine by conjugating OmpA, DnaK, Tul4 and SucB proteins of Francisella to TMV. CpG adjuvant was also included in the vaccine formulation. C57BL/6 mice were immunized intranasally (i.n.) on days 0, 14 and 28 and challenged with 10LD100 of Ft LVS on day 49 post-primary immunization (PPI). Mice were monitored for survival, weight loss, antibody and recall responses, and duration of immune protection. 100% of immunized mice were protected against a 10LD100 i.n. challenge dose of Ft LVS. Mice vaccinated with TMV-tetravalent vaccine showed high levels of TH1 antibodies than those with trivalent vaccine formulation. The challenged mice exhibited significantly reduced bacterial burden in lungs, liver and spleen. Strong ex-vivo recall responses were observed in immunized mice as late as day 84 PPI and 80% of mice survived when challenged 163 days PPI. Collectively, this study demonstrates that tetravalent vaccine formulation provides complete protection, induces strong protective and memory immune responses against respiratory challenge with F. tularensis.

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Bregu, Migena, Simon J. Draper, Adrian V. S. Hill, and Brian M. Greenwood. "Accelerating vaccine development and deployment: report of a Royal Society satellite meeting." Philosophical Transactions of the Royal Society B: Biological Sciences 366, no. 1579 (2011): 2841–49. http://dx.doi.org/10.1098/rstb.2011.0100.

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The Royal Society convened a meeting on the 17th and 18th November 2010 to review the current ways in which vaccines are developed and deployed, and to make recommendations as to how each of these processes might be accelerated. The meeting brought together academics, industry representatives, research sponsors, regulators, government advisors and representatives of international public health agencies from a broad geographical background. Discussions were held under Chatham House rules. High-throughput screening of new vaccine antigens and candidates was seen as a driving force for vaccine discovery. Multi-stakeholder, small-scale manufacturing facilities capable of rapid production of clinical grade vaccines are currently too few and need to be expanded. In both the human and veterinary areas, there is a need for tiered regulatory standards, differentially tailored for experimental and commercial vaccines, to allow accelerated vaccine efficacy testing. Improved cross-fertilization of knowledge between industry and academia, and between human and veterinary vaccine developers, could lead to more rapid application of promising approaches and technologies to new product development. Identification of best-practices and development of checklists for product development plans and implementation programmes were seen as low-cost opportunities to shorten the timeline for vaccine progression from the laboratory bench to the people who need it.

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D’Amico, Carmine, Flavia Fontana, Ruoyu Cheng, and Hélder A. Santos. "Development of vaccine formulations: past, present, and future." Drug Delivery and Translational Research 11, no. 2 (2021): 353–72. http://dx.doi.org/10.1007/s13346-021-00924-7.

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AbstractThe current situation, heavily influenced by the ongoing pandemic, puts vaccines back into the spotlight. However, the conventional and traditional vaccines present disadvantages, particularly related to immunogenicity, stability, and storage of the final product. Often, such products require the maintenance of a “cold chain,” impacting the costs, the availability, and the distribution of vaccines. Here, after a recall of the mode of action of vaccines and the types of vaccines currently available, we analyze the past, present, and future of vaccine formulation. The past focuses on conventional formulations, the present discusses the use of nanoparticles for vaccine delivery and as adjuvants, while the future presents microneedle patches as alternative formulation and administration route. Finally, we compare the advantages and disadvantages of injectable solutions, nanovaccines, and microneedles in terms of efficacy, stability, and patient-friendly design. Graphical abstract Different approaches to vaccine formulation development, the conventional vaccine formulations from the past, the current development of lipid nanoparticles as vaccines, and the near future microneedles formulations are discussed in this review.

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Shelburne, Christopher, Guojie Li, Herman Staats, and Soman Abraham. "Development of a novel anti-FimH vaccine using a mast cell activator as the adjuvant. (94.1)." Journal of Immunology 184, no. 1_Supplement (2010): 94.1. http://dx.doi.org/10.4049/jimmunol.184.supp.94.1.

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Abstract Urinary tract infections (UTIs) are one of the most common bacterial infections of man. Because of their high rate of recurrence and the increase in resistance of bacteria to antibiotics, there is great interest in developing a prophylactic vaccine to limit UTIs. Unfortunately, efforts to develop such a vaccine have failed in humans, quite possibly due to the use of alum as the vaccine adjuvant which does not induce protective immune responses along the urinary tract. Here, we demonstrate that a novel anti-UTI vaccine formulation consisted of the UTI vaccine antigen FimH and a mucosal mast cell activating adjuvant compound, mastoparan-7 is able to evoke protective immune responses against UTI. This vaccine formulation induced high titer anti-FimH IgA and IgG in both the urine and serum of immunized mice that were protective against subsequent challenge of the bladder site with uropathogenic E. coli. These anti-FimH responses were comparable to those elicited by FimH vaccine formulations containing cholera toxin as the adjuvant, and superior to those elicited by formulations containing the adjuvants CpGs or alum. These studies suggest that formulation of an anti-UTI vaccine with a MC activator and the FimH antigen might result in a successful anti-UTI vaccine in humans.

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Seyfinejad, Behrouz, Ommoleila Molavi, and Abolghasem Jouyban. "The Importance of Qualitative/Quantitative Analytical Tools in COVID-19 Vaccine Development." ImmunoAnalysis 3 (June 29, 2023): 8. http://dx.doi.org/10.34172/ia.2023.08.

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The COVID-19 pandemic has resulted in significant morbidity and mortality worldwide, emphasizing the need for effective vaccines. The development of a COVID-19 vaccine requires extensive analysis to ensure its safety and efficacy. In this review, the importance of analytical tools in COVID-19 vaccine development was discussed. A comprehensive literature search using PubMed and Scopus was conducted. Analytical tools play a crucial role in COVID-19 vaccine development, from the initial stages of antigen characterization to vaccine formulation and efficacy testing. The tools used include immunoassay-based methods, separation-based methods, and microscopy. These tools facilitate the characterization of antigens, selection of adjuvants, optimization of formulation, and stability testing. Moreover, analytical tools enable the evaluation of vaccine safety and efficacy, which are necessary for regulatory approval. Therefore, the implementation of analytical tools in COVID-19 vaccine development is crucial in ensuring the timely and successful development of a vaccine to combat the pandemic.

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Li, Lillian, Sung-In Back, Jian Ma, Yawen Guo, Thomas Galeandro-Diamant, and Didier Clénet. "Bayesian optimization and machine learning for vaccine formulation development." PLOS One 20, no. 6 (2025): e0324205. https://doi.org/10.1371/journal.pone.0324205.

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Developing vaccines with a better stability is an area of improvement to meet the global health needs of preventing infectious diseases. With the advancement of data science and artificial intelligence, innovative approaches have emerged. This manuscript highlights the applications of machine learning through two cases in which Bayesian optimization was used to develop viral vaccine formulations. The two case studies monitored the critical quality attributes of virus A in liquid form by infectious titer loss and virus B in freeze-dried form by glass transition temperature. Stepwise analysis and model optimization demonstrated progressive improvements of model quality and prediction accuracy. The cross-validation matrices of the models’ predictions showed high R² and low root mean square errors, indicating their reliability. The prediction accuracy of models was further validated by using test datasets. Model analysis using prediction error plot, Shapeley Additive exPlanations, permutation importance, etc. can provide additional insights into relations between model and experimental design, the influence of features of interest, and non-linear responses. Overall, Bayesian optimization is a useful complementary tool in formulation development that can help scientists make effective data-driven decisions.

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Alves-Ribeiro, Bruna Samara, Raiany Borges Duarte, Zara Mariana de Assis-Silva, et al. "Ehrlichia canis Vaccine Development: Challenges and Advances." Veterinary Sciences 11, no. 12 (2024): 624. https://doi.org/10.3390/vetsci11120624.

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Canine monocytic ehrlichiosis (CME) is an infectious disease caused by Ehrlichia canis, a globally recognized obligate intracellular bacterium. In addition to dogs, other animals, including humans, may be affected. Despite its epidemiological importance and impact on public health, there is currently no commercial vaccine against E. canis. This study aimed to present relevant aspects of the challenges and advances encountered in the development of vaccines for CME and highlight perspectives for future investigations. High genetic variability, along with the various evasion mechanisms employed by E. canis, has hindered the identification of an antigen that targets Th1 cells and is immunogenic to most E. canis isolates, considering their genotypic and phenotypic characteristics. The vaccine must predominantly confer cellular and humoral immunity to achieve robust immune responses. Early production efforts have been challenging due to low immunogenicity, difficulties in establishing long-term protection, and limitations of the techniques used. However, with the refinement of bioinformatic tools, research in this area will be facilitated, thereby accelerating the development of effective vaccines for CME. According to these authors, this vaccine should consist of multiple epitopes.

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Tager, A. M., M. Pensiero, and T. M. Allen. "Recent Advances in Humanized Mice: Accelerating the Development of an HIV Vaccine." Journal of Infectious Diseases 208, suppl 2 (2013): S121—S124. http://dx.doi.org/10.1093/infdis/jit451.

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Grady, Christine, Seema Shah, Franklin Miller, et al. "So much at stake: Ethical tradeoffs in accelerating SARSCoV-2 vaccine development." Vaccine 38, no. 41 (2020): 6381–87. http://dx.doi.org/10.1016/j.vaccine.2020.08.017.

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Griffin, J. "A strategic approach to vaccine development: animal models, monitoring vaccine efficacy, formulation and delivery." Advanced Drug Delivery Reviews 54, no. 6 (2002): 851–61. http://dx.doi.org/10.1016/s0169-409x(02)00072-8.

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Fang, Yuan. "The Role and Impact of Gene Editing on Vaccine Development." Theoretical and Natural Science 82, no. 1 (2025): 63–69. https://doi.org/10.54254/2753-8818/2025.ka21015.

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The application of gene editing technology in vaccine development has brought new hope for dealing with emerging and reemerging infectious diseases. Currently, gene editing tools, represented by CRISPR/Cas9, have significantly accelerated the vaccine development process and improved the safety and efficacy of vaccines by virtue of their highly efficient and precise operational characteristics. However, gene editing technology still suffers from off-target effects and high costs, and its wide application in vaccine development has yet to be further explored. This paper analyzed the application of gene editing technology in accelerating the construction of vaccine candidates, improving vaccine safety, and facilitating the design of novel vaccines (e.g., nucleic acid vaccines, viral vector vaccines, and subunit vaccines), and found that gene editing technology reduces the pathogenicity of pathogens by targeting the disease-causing genes, which makes vaccine research and development more efficient and safer. Gene editing provides a more precise and adaptable tool for future vaccine design, which can help to respond to infectious disease outbreaks more rapidly. Despite the limitations of the current technology, future research can further improve the accuracy and cost of gene editing, as well as further explore multivalent vaccine construction and high-throughput screening techniques, which will lead to further breakthroughs in the field of vaccines.

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OKADA, Naoki. "Development of a Patch Vaccine Formulation Utilizing the Microneedle Technology." Journal of the Japan Society for Precision Engineering 82, no. 12 (2016): 1023–26. http://dx.doi.org/10.2493/jjspe.82.1023.

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Komarovskaya, E. I., O. V. Proskurina, and A. A. Soldatov. "DPT vaccine evolution: Formulation differences, standardisation issues, and development prospects." Biological Products. Prevention, Diagnosis, Treatment 25, no. 1 (2025): 83–96. https://doi.org/10.30895/2221-996x-2025-25-1-83-96.

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INTRODUCTION. Currently, diphtheria, pertussis, and tetanus (DTP) vaccines are available in tetra-, penta-, and hexavalent combinations with inactivated poliomyelitis, Haemophilus influenzae, and hepatitis B components. Despite the widespread introduction of DTP vaccines in national vaccination programmes, concerns remain about the immunogenicity and safety of the pertussis component, the standardisation of vaccine production and quality control methods, and the inclusion of DTP vaccines in national routine vaccination schedules.AIM. This study aimed to provide an updated overview of DTP-based combined vaccines and analyse the current challenges associated with their use and quality improvement.DISCUSSION. DTP vaccines hold a central place in national routine vaccination schedules. The development of numerous safe and effective DTP vaccines has contributed to the formulation of DTP-based combined vaccines that include additional components and are suitable for infants. The addition of inactivated components against poliomyelitis, H. influenzae, and hepatitis B has facilitated the introduction of DTP-based combined vaccines into the recommended vaccination programmes and has reduced the number of injections received by a child. However, DTP-based combined vaccines from different manufacturers differ in the composition and quantity of antigens and in quality control methods. The key differences in the composition of these vaccines are due to the inclusion of either whole-cell or acellular pertussis. The current global rise in the incidence of pertussis is associated with the widespread use of acellular vaccines, which do not induce long-term immunity. This review considers the mutual influence of antigens in relation to vaccine efficacy and safety and addresses the standardisation issues associated with antigen production and quality control. The article analyses data on various DTP-based combined vaccines and the quantity of antigens in them. The review discusses promising areas for further improvement of the quality and effectiveness of DTP-based combined vaccines.CONCLUSIONS. Addressing unresolved standardisation issues in the production and quality control of DTP-based combined vaccines, which (along with country-specific licensing requirements) limit the international exchange of vaccines, can facilitate international recognition and ensure a high level of potency and safety of DTP-based combined vaccines.

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Askarizadeh, Anis, Mahmoud Reza Jaafari, Ali Khamesipour, and Ali Badiee. "Liposomal adjuvant development for leishmaniasis vaccines." Therapeutic Advances in Vaccines 5, no. 4-5 (2017): 85–101. http://dx.doi.org/10.1177/2051013617741578.

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Leishmaniasis is a parasitic disease that ranges in severity from skin lesions to fatality. Since long-lasting protection is induced upon recovery from cutaneous leishmaniasis, development of an effective vaccine is promising. However, there is no vaccine for use in humans yet. It seems limited efficacy in leishmaniasis vaccines is due to lack of an appropriate adjuvant or delivery system. Hence, the use of particulate adjuvants such as liposomes for effective delivery to the antigen presenting cells (APCs) is a valuable strategy to enhance leishmaniasis vaccine efficacy. The extraordinary versatility of liposomes because of their unique amphiphilic and biphasic nature allows for using antigens or immunostimulators within the core, on the surface or within the bilayer, and modulates both the magnitude and the T-helper bias of the immune response. In this review article, we attempt to summarize the role of liposomal adjuvants in the development of Leishmania vaccines and describe the main physicochemical properties of liposomes like phospholipid composition, surface charge, and particle size during formulation design. We also suggest potentially useful formulation strategies in order for future experiments to have a chance to succeed as liposomal vaccines against leishmaniasis.

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Wang, Hai-Bo, Qiu-Hua Mo, and Ze Yang. "HIV Vaccine Research: The Challenge and the Way Forward." Journal of Immunology Research 2015 (2015): 1–5. http://dx.doi.org/10.1155/2015/503978.

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Human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) is a worldwide epidemic, with over 35 million people infected currently. Therefore, the development of a safe and effective HIV-1 vaccine is on top of the global health priority. In the past few years, there have been many promising advances in the prevention of HIV/AIDS, among which the RV144 Thai trial has been encouraging and suggests optimization of the current vaccine strategies or search for novel strategies. Here we reviewed the brief history of HIV-1 vaccine, analyzed key challenges existing now, and illustrated future research priority/directions for a therapeutic or prophylactic HIV-1 vaccine, with the hope of accelerating the speed of vaccine development. We believe that an effective HIV-1 vaccine, together with other prevention approaches, will bring an end to this epidemic in the near future.

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Oosting, Linette, Katka Franke, Michael Martin, et al. "Development of a Personalized Tumor Neoantigen Based Vaccine Formulation (FRAME-001) for Use in a Phase II Trial for the Treatment of Advanced Non-Small Cell Lung Cancer." Pharmaceutics 14, no. 7 (2022): 1515. http://dx.doi.org/10.3390/pharmaceutics14071515.

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Stage III–IV non-small cell lung cancer (NSCLC) is a devastating disease characterized by a poor prognosis. NSCLC tumors carry genetic mutations, which can lead to the expression of altered protein sequences. Peptides originating from mutated proteins and bound to MHC molecules on the tumor cell surface are referred to as neoantigens, as they are tumor-specific and not expressed in normal cells. Due to their tumor specificity, neoantigens have a strong potential to induce an anti-tumor immune response and have been investigated for development of personalized therapeutic cancer vaccines. The current study describes the development of a clinical grade neoantigen vaccine formulation (FRAME-001) intended as immunotherapy in advanced NSCLC in combination with the immune checkpoint inhibitor pembrolizumab. The detection of aberrant tumor-specific transcripts as well as an algorithm to select immunogenic neoantigen peptides are described. Subsequently, selected neoantigen peptides were synthesized with a high throughput synthesis platform and aseptically formulated under good manufacturing practice (GMP) conditions into four aqueous peptides mixtures that each contained six neoantigen peptides. A validated stability-indicating analytical method was developed in which we considered the personalized nature of the formulation. An extensive stability study performed either at −25 °C or −80 °C showed that the formulation was stable for up to 32 weeks. The formulation was mixed with the vaccine adjuvant Montanide ISA 51 VG, which yielded the final vaccine emulsion. The stability of the vaccine emulsion was demonstrated using microscopic examination, differential light scattering, and the water-drop test. The presented data show that FRAME-001 is a feasible personalized vaccine formulation for the treatment of stage III–IV NSCLC. The presented data may give guidance in the development of novel personalized therapeutic vaccines since this formulation strategy could be used for any cancer indication.

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Kong, Hyunseung. "Advances in Personalized Cancer Vaccine Development: AI Applications from Neoantigen Discovery to mRNA Formulation." BioChem 5, no. 2 (2025): 5. https://doi.org/10.3390/biochem5020005.

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Personalized cancer vaccines are a promising immunotherapy targeting patient-specific tumor neoantigens, yet their design and efficacy remain challenging. Recent advances in artificial intelligence (AI) provide powerful tools to enhance multiple stages of cancer vaccine development. This review systematically evaluates AI applications in personalized cancer vaccine research over the past five years, focusing on four key areas: neoantigen discovery, codon optimization, untranslated region (UTR) sequence generation, and mRNA vaccine design. We examine AI model architectures (e.g., neural networks), datasets (from omics to high-throughput assays), and outcomes in improving vaccine development. In neoantigen discovery, machine learning and deep learning models integrate peptide–MHC binding, antigen processing, and T cell receptor recognition to enhance immunogenic neoantigen identification. For sequence optimization, deep learning models for codon and UTR design improve protein expression and mRNA stability beyond traditional methods. AI-driven strategies also optimize mRNA vaccine constructs and formulations, including secondary structures and nanoparticle delivery systems. We discuss how these AI approaches converge to streamline effective personalized vaccine development, while addressing challenges such as data scarcity, tumor heterogeneity, and model interpretability. By leveraging AI innovations, the future of personalized cancer immunotherapy may see unprecedented improvements in both design efficiency and clinical effectiveness.

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Sutrisno, Edy, Nila Kurniawati, Izzul Fatchu Reza, Alih Aji Nugroho, and Devina Khaerunisa. "Strategy for Accelerating Regional Development Reached Through Digital Governance." International Journal of Membrane Science and Technology 10, no. 2 (2023): 1200–1210. http://dx.doi.org/10.15379/ijmst.v10i2.1405.

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Regional areas in developing countries was trapped in high poverty rates. Previous studies have shown that the use of ICT can indirectly increase the productivity access of the poor. Aim: This study aims to formulate a digital governance strategy to support accelerated regional development in Lebak and Central Lombok districts, Indonesia. Materials: This study using a descriptive method with a mixed approach. Data was collected through interviews, documentation studies, and also distributing questionnaires to carry out weighting in the framework of strategy formulation. Data analysis was carried out through IFAS and EFAS analysis as well as matching through Internal External and SWOT matrices. Results: Research result and analysis shows that Lebak Regency and Central Lombok Regency are included in the average internal and external position and are in cell V. Conclusions: the development of Lebak and Central Lombok Regency in development through digital governance can be carried out by maintaining and maintaining existing strategies, expanding and developing regional potential through digital governance.

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Gupta, Amit, and Sushama R. Chaphalkar. "Development of novel plant-based adjuvant formulation against rubella and hepatitis B vaccine antigen." Herba Polonica 62, no. 3 (2016): 40–48. http://dx.doi.org/10.1515/hepo-2016-0016.

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Summary Introduction: Numerous metabolites present in the aqueous extract from plants are responsible for inducing adjuvant activity against rubella and hepatitis B vaccine antigen (HBsAg). One of the medicinal plants, Adhatoda vasica has been pointed out with great potential of vaccine adjuvant property. Objective: The objective of our study is to evaluate the adjuvant potential of aqueous leaves extract of Adhatoda vasica against rubella and hepatitis B vaccine antigen (HBsAg). Methods: For these studies, our group evaluated the antibody (IgG) titre of HBsAg and rubella vaccine antigen using variable doses (0.625–5 mg) of aqueous leaves extract of Adhatoda vasica and also determined the lymphocyte (splenocyte) proliferation assay (0.625–5 mg; 50 μl) in mice model studies ex vivo (i.e. immunized with HBsAg subcutaneously). Results: The results showed that aqueous leaves extract showed anti-HBsAg and anti-rubella titre and also enhanced the lymphocyte proliferation assay at higher doses (5 mg) as compared to control. Conclusion: Aqueous leaves extract of Adhatoda vasica showed adjuvant activity against HBsAg and rubella vaccine antigen.

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Bartutis*, Rosa Ramirez. "The Recombinant NS3 Protein a Potential Antigen for Dengue Vaccine Development." Journal of Biomedical Research & Environmental Sciences 5, no. 4 (2024): 290–95. http://dx.doi.org/10.37871/jbres1894.

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The NS3 protein is a multifunctional non-structural protein involved in dengue virus polyprotein processing. This protein is also target in the immune response against dengue virus infection. The predominance of cytotoxic T-cell lymphocytes epitopes in the NS3 structure suggests the participation of this protein in limiting virus replication and in the protection against dengue disease. A brief presentation on aspects related to antigenic characteristics and immunogenicity of the recombinant NS3 protein is reported in this work. A reduced number of studies have assessed the NS3 protein in a dengue vaccine formulation. Researches carried out in mice shown that DNA vaccines based on NS3 protein induced a protective response evaluated by their ability to produce IFNγ. Moreover, the incorporation of recombinant subunit NS3 in a purified inactivated vaccine significantly increased the immune response induced by this inactivated vaccine. Likewise, recent studies demonstrated that the combination of the recombinant modified-NS1 and NS3 proteins from dengue 2 virus induced higher immune responses and protection in mice. The immunological studies discussed herein support the possible inclusion of the NS3 protein in a dengue vaccine formulation.

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Ramin, Elham, Antonio Gaetano Cardillo, Reinhard Liebers, et al. "Accelerating vaccine manufacturing development through model-based approaches: current advances and future opportunities." Current Opinion in Chemical Engineering 43 (March 2024): 100998. http://dx.doi.org/10.1016/j.coche.2023.100998.

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Xiao, Emily, Clémentine Mirabel, Didier Clénet, et al. "Formulation Development of a COVID-19 Recombinant Spike Protein-Based Vaccine." Vaccines 12, no. 8 (2024): 830. http://dx.doi.org/10.3390/vaccines12080830.

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The purpose of this study was to develop a formulation for a recombinant prefusion spike protein vaccine against SARS-CoV-2. It was found that the spike protein was susceptible to aggregation due to mechanical stress. Therefore, formulation studies were initiated focused on screening pharmaceutical excipients capable of preventing this. The screening of a panel of potential stabilizing conditions found that Tween 20 could inhibit mechanically induced aggregation. A concentration-dependent study indicated that a higher concentration of Tween 20 (0.2% v/v) was required to prevent conformational changes in the trimer. The conformational changes induced by mechanical stress were characterized by size exclusion chromatography (SEC) and hydrogen–deuterium exchange mass spectrometry (HDX-MS), indicating the formation of an extended trimeric conformation that was also unable to bind to antibodies directed to the S2 domain. Long-term stability modeling, using advanced kinetic analysis, indicated that the formulation containing 0.2% (v/v) Tween 20 at a neutral pH was predicted to be stable for at least two years at 2 °C to 8 °C. Additional stabilizer screening conducted by thermal shift assay indicated that sucrose and glycerol were able to significantly increase the spike protein melting temperature (Tm) and improve the overall thermostability of the spike protein in a short-term stability study. Thus, while 0.2% (v/v) Tween 20 was sufficient to prevent aggregation and to maintain spike protein stability under refrigeration, the addition of sucrose further improved vaccine thermostability. Altogether, our study provides a systematic approach to the formulation of protein-based COVID-19 vaccine and highlights the impact of mechanical stress on the conformation of the spike protein and the significance of surfactants and stabilizers in maintaining the structural and functional integrity of the spike protein.

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Rodrigues, Margarida Q., Paula M. Alves, and António Roldão. "Functionalizing Ferritin Nanoparticles for Vaccine Development." Pharmaceutics 13, no. 10 (2021): 1621. http://dx.doi.org/10.3390/pharmaceutics13101621.

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In the last decade, the interest in ferritin-based vaccines has been increasing due to their safety and immunogenicity. Candidates against a wide range of pathogens are now on Phase I clinical trials namely for influenza, Epstein-Barr, and SARS-CoV-2 viruses. Manufacturing challenges related to particle heterogeneity, improper folding of fused antigens, and antigen interference with intersubunit interactions still need to be overcome. In addition, protocols need to be standardized so that the production bioprocess becomes reproducible, allowing ferritin-based therapeutics to become readily available. In this review, the building blocks that enable the formulation of ferritin-based vaccines at an experimental stage, including design, production, and purification are presented. Novel bioengineering strategies of functionalizing ferritin nanoparticles based on modular assembly, allowing the challenges associated with genetic fusion to be circumvented, are discussed. Distinct up/down-stream approaches to produce ferritin-based vaccines and their impact on production yield and vaccine efficacy are compared. Finally, ferritin nanoparticles currently used in vaccine development and clinical trials are summarized.

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Tabll, Ashraf A., Sayed S. Sohrab, Ahmed A. Ali, et al. "Future Prospects, Approaches, and the Government’s Role in the Development of a Hepatitis C Virus Vaccine." Pathogens 13, no. 1 (2023): 38. http://dx.doi.org/10.3390/pathogens13010038.

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Developing a safe and effective vaccine against the hepatitis C virus (HCV) remains a top priority for global health. Despite recent advances in antiviral therapies, the high cost and limited accessibility of these treatments impede their widespread application, particularly in resource-limited settings. Therefore, the development of the HCV vaccine remains a necessity. This review article analyzes the current technologies, future prospects, strategies, HCV genomic targets, and the governmental role in HCV vaccine development. We discuss the current epidemiological landscape of HCV infection and the potential of HCV structural and non-structural protein antigens as vaccine targets. In addition, the involvement of government agencies and policymakers in supporting and facilitating the development of HCV vaccines is emphasized. We explore how vaccine development regulatory channels and frameworks affect research goals, funding, and public health policy. The significance of international and public-private partnerships in accelerating the development of an HCV vaccine is examined. Finally, the future directions for developing an HCV vaccine are discussed. In conclusion, the review highlights the urgent need for a preventive vaccine to fight the global HCV disease and the significance of collaborative efforts between scientists, politicians, and public health organizations to reach this important public health goal.

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Mary-Gloria Chidiebere Iwunwa. "Strengthening vaccine development pipelines to combat emerging infectious diseases and antimicrobial resistance." World Journal of Advanced Research and Reviews 25, no. 2 (2025): 694–714. https://doi.org/10.30574/wjarr.2025.25.2.0453.

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The rapid emergence of infectious diseases and the escalating threat of antimicrobial resistance (AMR) present critical challenges to global public health. Traditional vaccine development pipelines, while effective in past decades, often lack the agility and scalability required to address these evolving threats. The COVID-19 pandemic highlighted both the vulnerabilities in current vaccine production systems and the transformative potential of innovations such as mRNA technology and platform-based vaccine designs. However, these advancements remain underutilized in combating other emerging infectious diseases and AMR. Strengthening vaccine development pipelines necessitates a multifaceted approach that integrates technological innovation, global collaboration, and regulatory agility. This paper explores strategies to enhance the efficiency and responsiveness of vaccine development, focusing on the incorporation of artificial intelligence (AI) and machine learning for predictive modeling, the expansion of genomic surveillance to track pathogen evolution, and the development of universal vaccine platforms adaptable to multiple pathogens. Additionally, addressing AMR through vaccines targeting resistant bacterial strains can significantly reduce the reliance on antibiotics, mitigating the spread of resistance. Public-private partnerships, funding mechanisms, and global policy alignment play pivotal roles in accelerating vaccine research and ensuring equitable distribution. This study emphasizes the need for proactive preparedness, highlighting case studies of successful vaccine rollouts and identifying gaps in the current infrastructure. By fostering innovation and global cooperation, the vaccine development ecosystem can be fortified to swiftly respond to future pandemics and the growing AMR crisis.

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Sun, Yao, Zhenwei Shen, Chun Zhang, et al. "Development of a Stable Liquid Formulation for Live Attenuated Influenza Vaccine." Journal of Pharmaceutical Sciences 108, no. 7 (2019): 2315–22. http://dx.doi.org/10.1016/j.xphs.2019.02.017.

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White, Jessica A., Marcus Estrada, E. Alexander Flood, Kutub Mahmood, Rajeev Dhere, and Dexiang Chen. "Development of a stable liquid formulation of live attenuated influenza vaccine." Vaccine 34, no. 32 (2016): 3676–83. http://dx.doi.org/10.1016/j.vaccine.2016.04.074.

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Flood, Alexander, Marcus Estrada, David McAdams, Yuhua Ji, and Dexiang Chen. "Development of a Freeze-Dried, Heat-Stable Influenza Subunit Vaccine Formulation." PLOS ONE 11, no. 11 (2016): e0164692. http://dx.doi.org/10.1371/journal.pone.0164692.

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Maa, Yuh‐Fun, Mahmoud Ameri, Cassandra Shu, Lendon G. Payne, and Dexiang Chen. "Influenza Vaccine Powder Formulation Development: Spray‐Freeze‐Drying and Stability Evaluation." Journal of Pharmaceutical Sciences 93, no. 7 (2004): 1912–23. http://dx.doi.org/10.1002/jps.20104.

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Kumar, Prashant, David A. Holland, Kathryn Secrist, et al. "Evaluating the Compatibility of New Recombinant Protein Antigens (Trivalent NRRV) with a Mock Pentavalent Combination Vaccine Containing Whole-Cell Pertussis: Analytical and Formulation Challenges." Vaccines 12, no. 6 (2024): 609. http://dx.doi.org/10.3390/vaccines12060609.

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Introducing new recombinant protein antigens to existing pediatric combination vaccines is important in improving coverage and affordability, especially in low- and middle-income countries (LMICs). This case-study highlights the analytical and formulation challenges encountered with three recombinant non-replicating rotavirus vaccine (NRRV) antigens (t-NRRV formulated with Alhydrogel® adjuvant, AH) combined with a mock multidose formulation of a pediatric pentavalent vaccine used in LMICs. This complex formulation contained (1) vaccine antigens (i.e., whole-cell pertussis (wP), diphtheria (D), tetanus (T), Haemophilus influenza (Hib), and hepatitis B (HepB), (2) a mixture of aluminum-salt adjuvants (AH and Adju-Phos®, AP), and (3) a preservative (thimerosal, TH). Selective, stability-indicating competitive immunoassays were developed to monitor binding of specific mAbs to each antigen, except wP which required the setup of a mouse immunogenicity assay. Simple mixing led to the desorption of t-NRRV antigens from AH and increased degradation during storage. These deleterious effects were caused by specific antigens, AP, and TH. An AH-only pentavalent formulation mitigated t-NRRV antigen desorption; however, the Hib antigen displayed previously reported AH-induced instability. The same rank-ordering of t-NRRV antigen stability (P[8] > P[4] > P[6]) was observed in mock pentavalent formulations and with various preservatives. The lessons learned are discussed to enable future multidose, combination vaccine formulation development with new vaccine candidates.

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Chouhan, Ashwin Singh. "The Role of the Vaccine Ingredients Used in the Manufacture of Vaccine." Global Academic Journal of Pharmacy and Drug Research 5, no. 01 (2023): 5–9. http://dx.doi.org/10.36348/gajpdr.2023.v05i01.002.

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Vaccine development platform technologies that can produce a wide range of vaccines are emerging. Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is a global pandemic which has induced unprecedented ramifications, severely affecting our society due to the long incubation time, unpredictably high prevalence and lack of effective vaccines. Safe and effective vaccine against coronavirus disease (COVID)-19, pharmaceutical formulation science plays a critical role throughout the development, manufacturing, distribution, and vaccination phases DNA technology can simplify the complexity of manufacturing and facilitate consistent production of large quantities of antigen. Messenger RNA (mRNA)-based vaccines have shown promise against infectious diseases and several types of cancer in the last two decades.

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Dangeti, Appalaraju, Deekshi Gladiola Bynagari, and Krishnaveni Vydani. "Revolutionizing Drug Formulation: Harnessing Artificial Intelligence and Machine Learning for Enhanced Stability, Formulation Optimization, and Accelerated Development." International Journal of Pharmaceutical Sciences and Medicine 8, no. 8 (2023): 18–29. http://dx.doi.org/10.47760/ijpsm.2023.v08i08.003.

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The integration of Artificial Intelligence (AI) and Machine Learning (ML) in the field of pharmaceutical drug formulation has sparked a paradigm shift in the way drug stability is predicted, formulations are optimized, and drug development is expedited. This review delves into the transformative impact of AI and ML techniques on pharmaceutical research and development. It highlights how predictive models driven by AI algorithms are effectively simulating drug degradation pathways and stability profiles, enabling scientists to make informed decisions during formulation design. Moreover, the utilization of ML algorithms to analyze vast datasets has led to the discovery of optimal formulations by identifying critical relationships between formulation variables, excipients, and drug properties. This approach not only reduces experimentation time and costs but also enhances the likelihood of developing robust and effective drug products. Furthermore, AI-powered drug development platforms are shortening the timeline for candidate selection, preclinical evaluations, and clinical trials, thereby accelerating the entire drug development process. This article explores the evolving landscape of AI and ML in drug formulation, discusses challenges, and anticipates future prospects in this transformative field.

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Walton, Jason. "The role of non-governmental organizations in vaccine development and delivery." International Journal of Health Governance 22, no. 3 (2017): 152–60. http://dx.doi.org/10.1108/ijhg-02-2017-0006.

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Purpose The purpose of this paper is to define the role non-governmental organizations (NGOs) play across the vaccine development and delivery spectrum within the vaccine enterprise. As demonstrated in this paper, NGOs can play a critical role in prioritizing and accelerating the development and introduction of new vaccines against diseases that disproportionally burden children, women, and communities in the poorest countries around the world. Design/methodology/approach The author has used case studies from decades of work by PATH, an international NGO, to help develop and implement vaccines, to illustrate the roles of NGOs can play during each of the stages along the development and delivery spectrum. Findings There are four key considerations that can help determine the ability of a given vaccine to be introduced and scaled within a health system: accessibility, affordability, acceptability, and availability. As more vaccine candidates are identified and move along the development and delivery pathway, there will be increased demand for NGOs to continue playing a pivotal role to address these considerations. Originality/value This paper aims to highlight a few of the lessons learned from PATH's four decades of experience in the hope they will contribute and be applied to the evolving environment of vaccine enterprise.

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Kensil, Charlotte R., C. Barrett, N. Kushner, et al. "Development of a genetically engineered vaccine against feline leukemia virus infection." Journal of the American Veterinary Medical Association 199, no. 10 (1991): 1423–27. http://dx.doi.org/10.2460/javma.1991.199.10.1423.

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Summary A genetically engineered subunit vaccine against FeLV infection was developed. The protective immunogen in the vaccine was a purified recombinant protein containing the entire amino acid sequence of FeLV subgroup A gp70 envelope protein. The optimal adjuvant was determined to be a highly purified saponin, QS-21, derived from Quillaja saponaria Molina. A vaccine formulation containing the recombinant protein, QS-21, and aluminum hydroxide was tested in specific-pathogen-free kittens and was shown to induce neutralizing antibodies as well as appreciable antibody responses to native gp70 by enzyme immunoassay and protein (western) immunoblot analysis and of whole virus preparations.

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Han, Sumin, Panjae Lee, and Hyo-Jick Choi. "Non-Invasive Vaccines: Challenges in Formulation and Vaccine Adjuvants." Pharmaceutics 15, no. 8 (2023): 2114. http://dx.doi.org/10.3390/pharmaceutics15082114.

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Given the limitations of conventional invasive vaccines, such as the requirement for a cold chain system and trained personnel, needle-based injuries, and limited immunogenicity, non-invasive vaccines have gained significant attention. Although numerous approaches for formulating and administrating non-invasive vaccines have emerged, each of them faces its own challenges associated with vaccine bioavailability, toxicity, and other issues. To overcome such limitations, researchers have created novel supplementary materials and delivery systems. The goal of this review article is to provide vaccine formulation researchers with the most up-to-date information on vaccine formulation and the immunological mechanisms available, to identify the technical challenges associated with the commercialization of non-invasive vaccines, and to guide future research and development efforts.

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Koff, Wayne C., Nina D. Russell, Mark Walport, et al. "Accelerating the development of a safe and effective HIV vaccine: HIV vaccine case study for the Decade of Vaccines." Vaccine 31 (April 2013): B204—B208. http://dx.doi.org/10.1016/j.vaccine.2012.10.115.

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Chatterjee, Rahul, Mrinmoy Ghosh, Susrita Sahoo, et al. "Next-Generation Bioinformatics Approaches and Resources for Coronavirus Vaccine Discovery and Development—A Perspective Review." Vaccines 9, no. 8 (2021): 812. http://dx.doi.org/10.3390/vaccines9080812.

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COVID-19 is a contagious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). To fight this pandemic, which has caused a massive death toll around the globe, researchers are putting efforts into developing an effective vaccine against the pathogen. As genome sequencing projects for several coronavirus strains have been completed, a detailed investigation of the functions of the proteins and their 3D structures has gained increasing attention. These high throughput data are a valuable resource for accelerating the emerging field of immuno-informatics, which is primarily aimed toward the identification of potential antigenic epitopes in viral proteins that can be targeted for the development of a vaccine construct eliciting a high immune response. Bioinformatics platforms and various computational tools and databases are also essential for the identification of promising vaccine targets making the best use of genomic resources, for further experimental validation. The present review focuses on the various stages of the vaccine development process and the vaccines available for COVID-19. Additionally, recent advances in genomic platforms and publicly available bioinformatics resources in coronavirus vaccine discovery together with related immunoinformatics databases and advances in technology are discussed.

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Michelson, Gary K. "Accelerating the Pace of Innovation for the Greater Good." Technology & Innovation 22, no. 2 (2022): 153–56. http://dx.doi.org/10.21300/22.2.2021.3.

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The COVID-19 pandemic has created the need for an accelerated drug development paradigm to bring vaccines to the masses. Several public-private partnerships, including Operation Warp Speed (OWS), helped fund an accelerated research & development (R&D) framework in which low-risk vaccines, likely to be successful, were supported via federal spending. This investment bore fruit less than a year later, with the approval of the first COVID-19 vaccines by Pfizer and OWS-supported Moderna. The collaborative problem solving and disruptive thinking demonstrated in the race to a COVID-19 vaccine has ushered in a new era of openness that has sped up global efforts. This race serves as proof-of-concept for an accelerated R&D framework. Establishing a "National Institute of Cures" could help cement this disruptive drug development process as permanent policy.

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Dumonteil, Eric, Maria Elena Bottazzi, Bin Zhan, et al. "Accelerating the development of a therapeutic vaccine for human Chagas disease: rationale and prospects." Expert Review of Vaccines 11, no. 9 (2012): 1043–55. http://dx.doi.org/10.1586/erv.12.85.

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Journal articles on the topic 'Accelerating vaccine formulation development'

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