Quality by Design in Pharmaceuticals

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Physical Pharmacy and Formulation".

Deadline for manuscript submissions: closed (31 August 2023) | Viewed by 1461

Special Issue Editors


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Guest Editor
Department of Chemistry, Rhodes University, Makhanda 6140, South Africa
Interests: polymorphism; co-crystals; DoE

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Guest Editor
Faculty of Pharmacy, Rhodes University, Makhanda 6140, South Africa
Interests: formulation; QbD; DoE; pharmaceutical analysis
Special Issues, Collections and Topics in MDPI journals
Department of Pharmaceutical Sciences, Bouvé College of Health Sciences, Northeastern University, Boston, MA 02115, USA
Interests: nanoparticle-based drug delivery systems; long acting parenterals; topical dosage forms; in vitro dissolution testing; in vitro and in vivo correlation; quality control
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Statistical approaches using efficient experiment designs are often used to optimize and expedite pharmaceutical product development, an otherwise time-consuming process. Furthermore, the current approach to enhancing rather than testing product quality is useful at multiple levels. This themed issue will consider manuscripts in all areas of product development, including drug design, processes, formulation and product optimization, as well as quality control, in which a quality-by-design approach is at the forefront of the research.

Dr. Vincent J Smith
Prof. Dr. Roderick B. Walker
Dr. Jie Shen
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

  • QbD
  • API
  • process development and optimization
  • formulation development and optimization
  • analytical method development and optimization
  • quality target product profile (QTPP)

Published Papers (1 paper)

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Research

13 pages, 3440 KiB  
Article
Whole Yeast Vaccine Displaying ZIKV B and T Cell Epitopes Induces Cellular Immune Responses in the Murine Model
by Anna Jéssica Duarte Silva, André Luiz Santos de Jesus, Lígia Rosa Sales Leal, Larissa Silva de Macêdo, Bárbara Rafaela da Silva Barros, Georon Ferreira de Sousa, Simone da Paz Leôncio Alves, Lindomar José Pena, Cristiane Moutinho Lagos de Melo and Antonio Carlos de Freitas
Pharmaceutics 2023, 15(7), 1898; https://doi.org/10.3390/pharmaceutics15071898 - 06 Jul 2023
Viewed by 1138
Abstract
Improving antigen presentation is crucial for the success of immunization strategies. Yeasts are classically used as biofactories to produce recombinant proteins and are efficient vehicles for antigen delivery, in addition to their adjuvant properties. Despite the absence of epidemic outbreaks, several vaccine approaches [...] Read more.
Improving antigen presentation is crucial for the success of immunization strategies. Yeasts are classically used as biofactories to produce recombinant proteins and are efficient vehicles for antigen delivery, in addition to their adjuvant properties. Despite the absence of epidemic outbreaks, several vaccine approaches continue to be developed for Zika virus infection. The development of these prophylactic strategies is fundamental given the severity of clinical manifestations, mainly due to viral neurotropism. The present study aimed to evaluate in vivo the immune response induced by P. pastoris recombinant strains displaying epitopes of the envelope (ENV) and NS1 ZIKV proteins. Intramuscular immunization with heat-attenuated yeast enhanced the secretion of IL-6, TNF-α, and IFN-γ, in addition to the activation of CD4+ and CD8+ T cells, in BALB/c mice. P. pastoris displaying ENV epitopes induced a more robust immune response, increasing immunoglobulin production, especially IgG isotypes. Both proposed vaccines showed the potential to induce immune responses without adverse effects, confirming the safety of administering P. pastoris as a vaccine vehicle. Here, we demonstrated, for the first time, the evaluation of a vaccine against ZIKV based on a multiepitope construct using yeast as a delivery system and reinforcing the applicability of P. pastoris as a whole-cell vaccine. Full article
(This article belongs to the Special Issue Quality by Design in Pharmaceuticals)
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