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Article ; Online: 9 to 5 in Academia: Addressing Barriers for Women.

Ainslie, Kristy M

2022 Volume 20, Issue 1, Page(s) 1–3

MeSH term(s)	Humans ; Female ; Career Mobility
Language	English
Publishing date	2022-11-11
Publishing country	United States
Document type	Editorial
ZDB-ID	2138405-8
ISSN	1543-8392 ; 1543-8384
ISSN (online)	1543-8392
ISSN	1543-8384
DOI	10.1021/acs.molpharmaceut.2c00899
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Article ; Online: Clinical and Preclinical Methods of Heat-Stabilization of Human Vaccines.

Williamson, Grace L / Bachelder, Eric M / Ainslie, Kristy M

Molecular pharmaceutics

2024 Volume 21, Issue 3, Page(s) 1015–1026

Abstract: Vaccines have historically faced challenges regarding stability, especially in regions lacking a robust cold chain infrastructure. This review delves into established and emergent techniques to improve the thermostability of vaccines. We discuss the ... ...

Abstract	Vaccines have historically faced challenges regarding stability, especially in regions lacking a robust cold chain infrastructure. This review delves into established and emergent techniques to improve the thermostability of vaccines. We discuss the widely practiced lyophilization method, effectively transforming liquid vaccine formulations into a solid powdered state, enhancing storage and transportation ability. However, potential protein denaturation during lyophilization necessitates alternative stabilization methods. Cryoprotectants, namely, starch and sugar molecules, have shown promise in protecting vaccine antigens and adjuvants from denaturation and augmenting the stability of biologics during freeze-drying. Biomineralization, a less studied yet innovative approach, utilizes inorganic or organic-inorganic hybrids to encapsulate biological components of vaccines with a particular emphasis on metal-organic coordination polymers. Encapsulation in organic matrices to form particles or microneedles have also been studied in the context of vaccine thermostability, showing some ability to store outside the cold-chain. Unfortunately, few of these techniques have advanced to clinical trials that evaluate differences in storage conditions. Nonetheless, early trials suggest that alternative storage techniques are viable and emphasize the need for more comprehensive studies. This review underscores the pressing need for heat-stable vaccines, especially in light of the increasing global distribution challenges. Combining traditional methods with novel approaches holds promise for the future adaptability of vaccine distribution and use.
MeSH term(s)	Humans ; Hot Temperature ; Drug Stability ; Vaccines ; Drug Compounding/methods ; Vaccination ; Freeze Drying/methods
Chemical Substances	Vaccines
Language	English
Publishing date	2024-01-30
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2138405-8
ISSN	1543-8392 ; 1543-8384
ISSN (online)	1543-8392
ISSN	1543-8384
DOI	10.1021/acs.molpharmaceut.3c00844
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Article ; Online: Distribution of Female and Male First and Last Authorship across Drug Delivery Related Journals with Respect to Year and Journal Impact Factor.

McLaughlin, Jacqueline E / Bachelder, Jacob M / Ainslie, Kristy M

Molecular pharmaceutics

2023 Volume 20, Issue 8, Page(s) 4219–4227

Abstract: First and last authorship are important metrics of productivity and scholarly success for trainees and professors. For 11 drug delivery-related journals in 2021, the percentage of female first (39.5%) and last (25.7%) authorship was reported. A strong ... ...

Abstract	First and last authorship are important metrics of productivity and scholarly success for trainees and professors. For 11 drug delivery-related journals in 2021, the percentage of female first (39.5%) and last (25.7%) authorship was reported. A strong negative correlation, with female first (
MeSH term(s)	Male ; Humans ; Female ; Journal Impact Factor ; Authorship ; Periodicals as Topic
Language	English
Publishing date	2023-06-23
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2138405-8
ISSN	1543-8392 ; 1543-8384
ISSN (online)	1543-8392
ISSN	1543-8384
DOI	10.1021/acs.molpharmaceut.3c00328
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Article ; Online: The AAPS Journal Theme Issue: Rising Stars in Drug Delivery and Novel Carriers.

Salem, Aliasger K / Nguyen, Juliane / Ainslie, Kristy M

The AAPS journal

2022 Volume 24, Issue 3, Page(s) 51

MeSH term(s)	Antipsychotic Agents/therapeutic use ; Drug Delivery Systems
Chemical Substances	Antipsychotic Agents
Language	English
Publishing date	2022-04-05
Publishing country	United States
Document type	Editorial
ISSN	1550-7416
ISSN (online)	1550-7416
DOI	10.1208/s12248-022-00700-6
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Article: Multi-COBRA hemagglutinin formulated with cGAMP microparticles elicit protective immune responses against influenza viruses.

Zhang, Xiaojian / Shi, Hua / Hendy, Dylan A / Bachelder, Eric M / Ainslie, Kristy M / Ross, Ted M

bioRxiv : the preprint server for biology

2024

Abstract: Influenza viruses cause a common respiratory disease known as influenza. In humans, seasonal influenza viruses can lead to epidemics, with avian influenza viruses of particular concern because they can infect multiple species and lead to unpredictable ... ...

Abstract	Influenza viruses cause a common respiratory disease known as influenza. In humans, seasonal influenza viruses can lead to epidemics, with avian influenza viruses of particular concern because they can infect multiple species and lead to unpredictable and severe disease. Therefore, there is an urgent need for a universal influenza vaccine that provides protection against seasonal and pre-pandemic influenza virus strains. The cyclic GMP-AMP (cGAMP) is a promising adjuvant for subunit vaccines that promotes type I interferons production through the stimulator of interferon genes (STING) pathway. The encapsulation of cGAMP in acetalated dextran (Ace-DEX) microparticles (MPs) enhances its intracellular delivery. In this study, the Computationally Optimized Broadly Reactive Antigen (COBRA) methodology was used to generate H1, H3, and H5 vaccine candidates. Monovalent and multivalent COBRA HA vaccines formulated with cGAMP Ace-DEX MPs were evaluated in a mouse model for antibody responses and protection against viral challenge. Serological analysis showed that cGAMP MPs adjuvanted monovalent and multivalent COBRA vaccines elicited robust antigen-specific antibody responses after a prime-boost vaccination and antibody titers were further enhanced after second boost. Compared to COBRA vaccine groups with no adjuvant or blank MPs, the cGAMP MPs enhanced HAI antibody responses against COBRA vaccination. The HAI antibody titers were not significantly different between cGAMP MPs adjuvanted monovalent and multivalent COBRA vaccine groups for most of the viruses tested in panels. The cGAMP MPs adjuvanted COBRA vaccines groups had higher antigen-specific IgG2a binding titers than the COBRA vaccine groups with no adjuvant or blank MPs. The COBRA vaccines formulated with cGAMP MPs mitigated disease caused by influenza viral challenge and decreased pulmonary viral titers in mice. Therefore, the formulation of COBRA vaccines plus cGAMP MPs is a promising universal influenza vaccine that elicits protective immune responses against human seasonal and pre-pandemic strains.
Language	English
Publishing date	2024-02-29
Publishing country	United States
Document type	Preprint
DOI	10.1101/2024.02.27.582355
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Article ; Online: Preclinical developments in the delivery of protein antigens for vaccination.

Hendy, Dylan A / Haven, Alex / Bachelder, Eric M / Ainslie, Kristy M

Expert opinion on drug delivery

2023 Volume 20, Issue 3, Page(s) 367–384

Abstract: Introduction: Vaccine technology has constantly advanced since its origin. One of these advancements is where purified parts of a pathogen are used rather than the whole pathogen. Subunit vaccines have no chance of causing disease; however, alone these ... ...

Abstract	Introduction: Vaccine technology has constantly advanced since its origin. One of these advancements is where purified parts of a pathogen are used rather than the whole pathogen. Subunit vaccines have no chance of causing disease; however, alone these antigens are often poorly immunogenic. Therefore, they can be paired with immune stimulating adjuvants. Further, subunits can be combined with delivery strategies such as nano/microparticles to enrich their delivery to organs and cells of interest as well as protect them from in vivo degradation. Here, we seek to highlight some of the more promising delivery strategies for protein antigens. Areas covered: We present a brief description of the different types of vaccines, clinically relevant examples, and their disadvantages when compared to subunit vaccines. Also, specific preclinical examples of delivery strategies for protein antigens. Expert opinion: Subunit vaccines provide optimal safety given that they have no risk of causing disease; however, they are often not immunogenic enough on their own to provide protection. Advanced delivery systems are a promising avenue to increase the immunogenicity of subunit vaccines, but scalability and stability can be improved. Further, more research is warranted on systems that promote a mucosal immune response to provide better protection against infection.
MeSH term(s)	Vaccination ; Vaccines ; Vaccines, Subunit ; Antigens ; Immunity, Mucosal ; Adjuvants, Immunologic
Chemical Substances	Vaccines ; Vaccines, Subunit ; Antigens ; Adjuvants, Immunologic
Language	English
Publishing date	2023-02-10
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2167286-6
ISSN	1744-7593 ; 1742-5247
ISSN (online)	1744-7593
ISSN	1742-5247
DOI	10.1080/17425247.2023.2176844
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Article ; Online: Drug Delivery Systems for Localized Cancer Combination Therapy.

Woodring, Ryan N / Gurysh, Elizabeth G / Bachelder, Eric M / Ainslie, Kristy M

ACS applied bio materials

2023 Volume 6, Issue 3, Page(s) 934–950

Abstract: With over 2 million cancer cases and over 600,000 cancer-associated deaths predicted in the U.S. for 2022, this life-debilitating disease continuously impacts the lives of people across the nation every day. Therapeutic treatment options for cancer have ... ...

Abstract	With over 2 million cancer cases and over 600,000 cancer-associated deaths predicted in the U.S. for 2022, this life-debilitating disease continuously impacts the lives of people across the nation every day. Therapeutic treatment options for cancer have historically involved chemotherapies to eradicate tumors with cytotoxic mechanisms which can negatively affect the efficacy versus toxicity ratio of treatment. With a need for more directed and therapeutically active options, targeted small-molecule inhibitors and immunotherapies have since emerged to mitigate treatment-associated toxicities. However, aggressive tumors can employ a wide range of defense mechanisms to evade monotherapy treatment altogether, resulting in the recurrence of therapeutically resistant tumors. Therefore, many clinical routines have included combination therapy in which anticancer agents are combined to provide a synergistic attack on tumors. Even with this approach, maximizing the efficacy of cancer treatment is contingent upon the dose of drug that reaches the site of the tumor, so often therapy is administered at the site of a tumor via localized delivery platforms. Commonly used platforms for localized drug delivery include polymeric wafers, nanofibrous scaffolds, and hydrogels where drug combinations can be loaded and delivered synchronously. Attaining synergistic activity from these localized systems is dependent on proper material selection and fabrication methods. Herein, we describe these important considerations for enhancing the efficacy of cancer combination therapy through biodegradable, localized delivery systems.
MeSH term(s)	Humans ; Drug Delivery Systems ; Neoplasms/drug therapy ; Neoplasms/pathology ; Antineoplastic Agents/pharmacology ; Polymers ; Combined Modality Therapy
Chemical Substances	Antineoplastic Agents ; Polymers
Language	English
Publishing date	2023-02-15
Publishing country	United States
Document type	Journal Article ; Review
ISSN	2576-6422
ISSN (online)	2576-6422
DOI	10.1021/acsabm.2c00973
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Article ; Online: Metal-organic coordination polymers for delivery of immunomodulatory agents, and infectious disease and cancer vaccines.

Pena, Erik S / Lifshits, Liubov M / Eckshtain-Levi, Meital / Bachelder, Eric M / Ainslie, Kristy M

Wiley interdisciplinary reviews. Nanomedicine and nanobiotechnology

2023 Volume 15, Issue 4, Page(s) e1877

Abstract: Metal-organic coordination polymers (CPs) are a broad class of materials that include metal-organic frameworks (MOFs). CPs are highly ordered crystalline materials that are composed of metal ions (or metal ion clusters) and multidentate organic ligands ... ...

Abstract	Metal-organic coordination polymers (CPs) are a broad class of materials that include metal-organic frameworks (MOFs). CPs are highly ordered crystalline materials that are composed of metal ions (or metal ion clusters) and multidentate organic ligands that serve as linkers. One-, two-, and three-dimensional CPs can be formed, with 2D and 3D structures referred to as MOFs. CPs have gained a lot of attention due to attractive structural features like structure versatility and tunability, and well-defined pores that enable the encapsulation of cargo. Further, CPs show a lot of promise for drug delivery applications, but only a very limited number of CPs are currently being evaluated in clinical trials. In this review, we outlined features that are desired for CP-based drug delivery platform, and briefly described most relevant characterization techniques. We highlighted some of the recent efforts directed toward developing CP-based drug delivery platforms with the emphasis on vaccines against cancer, infectious diseases, and viruses. We hope this review will be a helpful guide for those interested in the design and evaluation of CP-based immunological drug delivery platforms. This article is categorized under: Therapeutic Approaches and Drug Discovery > Nanomedicine for Infectious Disease Therapeutic Approaches and Drug Discovery > Nanomedicine for Oncologic Disease.
MeSH term(s)	Humans ; Polymers/chemistry ; Cancer Vaccines ; Immunomodulating Agents ; Metal-Organic Frameworks/chemistry ; Metals ; Communicable Diseases ; Neoplasms/drug therapy
Chemical Substances	Polymers ; Cancer Vaccines ; Immunomodulating Agents ; Metal-Organic Frameworks ; Metals
Language	English
Publishing date	2023-01-11
Publishing country	United States
Document type	Journal Article ; Review ; Research Support, N.I.H., Extramural
ZDB-ID	2502698-7
ISSN	1939-0041 ; 1939-5116
ISSN (online)	1939-0041
ISSN	1939-5116
DOI	10.1002/wnan.1877
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Article ; Online: Historical Perspective of Clinical Nano and Microparticle Formulations for Delivery of Therapeutics.

Batty, Cole J / Bachelder, Eric M / Ainslie, Kristy M

Trends in molecular medicine

2021 Volume 27, Issue 6, Page(s) 516–519

Abstract: Nano and micro-technologies are used for therapeutic delivery of biologics and small molecules in formulations ranging in size from one nanometer to 100 microns or more. Here we review the unique physiochemical properties of these technologies and how ... ...

Abstract	Nano and micro-technologies are used for therapeutic delivery of biologics and small molecules in formulations ranging in size from one nanometer to 100 microns or more. Here we review the unique physiochemical properties of these technologies and how they lead to more beneficial drug pharmacokinetics and toxicity over conventional formulations.
MeSH term(s)	Drug Carriers/chemistry ; Drug Delivery Systems ; History, 20th Century ; History, 21st Century ; Humans ; Nanoparticles/administration & dosage ; Nanoparticles/chemistry ; Nanotechnology/history ; Particle Size ; Pharmaceutical Preparations/administration & dosage ; Pharmaceutical Preparations/chemistry ; Polymers/chemistry
Chemical Substances	Drug Carriers ; Pharmaceutical Preparations ; Polymers
Language	English
Publishing date	2021-04-23
Publishing country	England
Document type	Historical Article ; Journal Article ; Research Support, N.I.H., Extramural ; Review
ZDB-ID	2036490-8
ISSN	1471-499X ; 1471-4914
ISSN (online)	1471-499X
ISSN	1471-4914
DOI	10.1016/j.molmed.2021.04.002
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Article: Micro and nanotechnologies: The little formulations that could.

Stiepel, Rebeca T / Duggan, Eliza / Batty, Cole J / Ainslie, Kristy M

Bioengineering & translational medicine

2022 Volume 8, Issue 2, Page(s) e10421

Abstract: The first publication of micro- and nanotechnology in medicine was in 1798 with the use of the Cowpox virus by Edward Jenner as an attenuated vaccine against Smallpox. Since then, there has been an explosion of micro- and nanotechnologies for medical ... ...

Abstract	The first publication of micro- and nanotechnology in medicine was in 1798 with the use of the Cowpox virus by Edward Jenner as an attenuated vaccine against Smallpox. Since then, there has been an explosion of micro- and nanotechnologies for medical applications. The breadth of these micro- and nanotechnologies is discussed in this piece, presenting the date of their first report and their latest progression (e.g., clinical trials, FDA approval). This includes successes such as the recent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines from Pfizer, Moderna, and Janssen (Johnson & Johnson) as well as the most popular nanoparticle therapy, liposomal Doxil. However, the enormity of the success of these platforms has not been without challenges. For example, we discuss why the production of Doxil was halted for several years, and the bankruptcy of BIND therapeutics, which relied on a nanoparticle drug carrier. Overall, the field of micro- and nanotechnology has advanced beyond these challenges and continues advancing new and novel platforms that have transformed therapies, vaccines, and imaging. In this review, a wide range of biomedical micro- and nanotechnology is discussed to serve as a primer to the field and provide an accessible summary of clinically relevant micro- and nanotechnology platforms.
Language	English
Publishing date	2022-10-18
Publishing country	United States
Document type	Journal Article ; Review
ISSN	2380-6761
ISSN	2380-6761
DOI	10.1002/btm2.10421
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