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Pharmaceutics
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Recent Advances in the Development, Characterization, and Stability Aspects of...
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Recent Advances in the Development, Characterization, and Stability Aspects of RNA-Based Vaccines

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Gene and Cell Therapy".

Deadline for manuscript submissions: 20 February 2026 | Viewed by 5318

Special Issue Editors

Dr. Ravi Maharjan

E-Mail Website
Guest Editor
Department of Pharmaceutical Technology, Dongguk University, Seoul 04620, Republic of Korea
Interests: mRNA vaccines; lyophilization; vaccine stability; continuous manufacturing
Special Issues, Collections and Topics in MDPI journals
Dr. Surin Hong

E-Mail Website
Guest Editor
Department of Biotechnology, College of Life Science, CHA University, Gyeonggi 13488, Republic of Korea
Interests: nanomaterial; drug delivery; nano biosensor; plasmonic
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

The rapid development and subsequent implementation of RNA-based vaccines during the global COVID-19 pandemic not only transformed the landscape of vaccine technology but also paved the way for novel therapeutic applications that were previously unimaginable. This particular Special Issue aims to compile and present the most recent and noteworthy advancements in the realm of RNA vaccine research, including but not limited to, lipid nanoparticle (LNP) formulation strategies, novel characterization methodology, cryoprotectants for lyophilization, and the impact of storage conditions on vaccine performance.

We extend a cordial invitation to researchers and scholars to submit their research or review article contributions to this Special Issue. Through state-of-the-art research and the promotion of collaborative efforts among scientists within this discipline, we hope to advance the collective understanding and practical applications of RNA technology. We strongly encourage authors to provide in-depth insights and comprehensive data that have the potential to inspire further research and development endeavors in this highly promising and rapidly evolving area of study.

Dr. Ravi Maharjan
Dr. Surin Hong
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmaceutics is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2900 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • RNA-based vaccines
  • lyophilization
  • stability
  • gene therapy
  • formulation strategies
  • novel characterization
  • delivery systems
  • biopharmaceuticals
  • continuous manufacturing
  • AI/ML/digital twin

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Published Papers (2 papers)

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Review

31 pages, 2007 KB  
Review
Artificial Intelligence-Driven Strategies for Targeted Delivery and Enhanced Stability of RNA-Based Lipid Nanoparticle Cancer Vaccines
by Ripesh Bhujel, Viktoria Enkmann, Hannes Burgstaller and Ravi Maharjan
Pharmaceutics 2025, 17(8), 992; https://doi.org/10.3390/pharmaceutics17080992 - 30 Jul 2025
Cited by 1 | Viewed by 1601
Abstract
The convergence of artificial intelligence (AI) and nanomedicine has transformed cancer vaccine development, particularly in optimizing RNA-loaded lipid nanoparticles (LNPs). Stability and targeted delivery are major obstacles to the clinical translation of promising RNA-LNP vaccines for cancer immunotherapy. This systematic review analyzes the [...] Read more.
The convergence of artificial intelligence (AI) and nanomedicine has transformed cancer vaccine development, particularly in optimizing RNA-loaded lipid nanoparticles (LNPs). Stability and targeted delivery are major obstacles to the clinical translation of promising RNA-LNP vaccines for cancer immunotherapy. This systematic review analyzes the AI’s impact on LNP engineering through machine learning-driven predictive models, generative adversarial networks (GANs) for novel lipid design, and neural network-enhanced biodistribution prediction. AI reduces the therapeutic development timeline through accelerated virtual screening of millions of lipid combinations, compared to conventional high-throughput screening. Furthermore, AI-optimized LNPs demonstrate improved tumor targeting. GAN-generated lipids show structural novelty while maintaining higher encapsulation efficiency; graph neural networks predict RNA-LNP binding affinity with high accuracy vs. experimental data; digital twins reduce lyophilization optimization from years to months; and federated learning models enable multi-institutional data sharing. We propose a framework to address key technical challenges: training data quality (min. 15,000 lipid structures), model interpretability (SHAP > 0.65), and regulatory compliance (21CFR Part 11). AI integration reduces manufacturing costs and makes personalized cancer vaccine affordable. Future directions need to prioritize quantum machine learning for stability prediction and edge computing for real-time formulation modifications. Full article
(This article belongs to the Special Issue Recent Advances in the Development, Characterization, and Stability Aspects of RNA-Based Vaccines)
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22 pages, 2633 KB  
Review
Implications of Anaphylaxis Following mRNA-LNP Vaccines: It Is Urgent to Eliminate PEG and Find Alternatives
by Jinxing Song, Dihan Su, Hongbing Wu and Jeremy Guo
Pharmaceutics 2025, 17(6), 798; https://doi.org/10.3390/pharmaceutics17060798 - 19 Jun 2025
Viewed by 3257
Abstract
The mRNA vaccine has protected humans from the Coronavirus disease 2019 (COVID-19) and has taken the lead in reversing the epidemic efficiently. However, the Centre of Disease Control (CDC) reported and raised the alarm of allergic or acute inflammatory adverse reactions after vaccination [...] Read more.
The mRNA vaccine has protected humans from the Coronavirus disease 2019 (COVID-19) and has taken the lead in reversing the epidemic efficiently. However, the Centre of Disease Control (CDC) reported and raised the alarm of allergic or acute inflammatory adverse reactions after vaccination with mRNA-LNP vaccines. Meanwhile, the US Food and Drug Administration (FDA) has added four black-box warnings in the instructions for mRNA-LNP vaccines. Numerous studies have proven that the observance of side effects after vaccination is indeed positively correlated to the level of anti-PEG antibodies (IgM or IgG), which are enhanced by PEGylated preparations like LNP vaccine and environmental exposure. After literature research and review in the past two decades, it was found that the many clinical trial failures (BIND-014, RB006 fell in phase II) of PEG modified delivery system or PEGylated drug were related to the high expression of anti-PEG IgM and IgG. In the background of shooting multiple mRNA-LNP vaccines in billions of people around the world in the past three years, the level of anti-PEG antibodies in the population may have significantly increased, which brings potential risks for PEG-modified drug development and clinical safety. This review summarizes the experience of using mRNA-LNP vaccines from the mechanism of the anti-PEG antibodies generation, detection methods, clinical failure cases of PEG-containing products, harm analysis of abuse of PEGylation, and alternatives. In light of the increasing prevalence of anti-PEG antibodies in the population and the need to avoid secondary injuries, this review article holds greater significance by offering insights for drug developers. It suggests avoiding the use of PEG excipients when designing PEGylated drugs or PEG-modified nano-formulations and provides references for strategies such as utilizing PEG-free or alternative excipients. Full article
(This article belongs to the Special Issue Recent Advances in the Development, Characterization, and Stability Aspects of RNA-Based Vaccines)
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