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Pharmaceutics
Special Issues
Formulation of Biopharmaceuticals and Advanced Therapy Medicinal Products (ATMPs)
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Formulation of Biopharmaceuticals and Advanced Therapy Medicinal Products (ATMPs)

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Biopharmaceutics".

Deadline for manuscript submissions: closed (31 July 2023) | Viewed by 3002

Special Issue Editors

Dr. Ana Catarina Silva

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Guest Editor
1. UCIBIO/REQUIMTE, MEDTECH, Laboratory of Pharmaceutical Technology, Department of Drug Sciences, Faculty of Pharmacy, University of Porto, 4050-313 Porto, Portugal
2. FP-I3ID (Instituto de Investigação, Inovação e Desenvolvimento), FP-BHS (Biomedical and Health Sciences Research Unit), Faculty of Health Sciences, University Fernando Pessoa, 4249-004 Porto, Portugal
Interests: lipid nanoparticles; nose-to-brain delivery; cutaneous delivery; drug delivery systems; biopharmaceutics; biological medicines; biosimilars
Special Issues, Collections and Topics in MDPI journals
Prof. Dr. José Manuel Sousa Lobo

E-Mail Website1 Website2
Guest Editor
UCIBIO, REQUIMTE, Laboratory of Pharmaceutical Technology, Centre of Research in Pharmaceutical Sciences, Faculty of Pharmacy, University of Porto, Porto, Portugal
Interests: pharmaceutical technology; biopharmacy; pharmacokinetics; pharmaceutical nanotechnology
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Biopharmaceuticals mainly comprise recombinant proteins that have brought innovative therapeutic solutions to different medical conditions, through biological and biosimilar medicines, which may contain monoclonal antibodies, cytokines, growth factors hormones, enzymes, vaccines or blood products. In addition, advanced therapy medicinal products (ATMPs), including genes, cells and tissues, offer alternative and effective clinical solutions to unmet medical needs.

The formulation of biopharmaceuticals and ATMPs is challenging due to the sensitivity of proteins, DNA and RNA, cells and tissues, which can also hinder their stability in the body environment. Furthermore, the high molecular size and hydrophilicity of most of these products prevent their passage through biological barriers. These limitations require that most of these medicines be for parenteral administration, which increases the cost of industrial manufacture and decreases patient adherence to therapy.

Several investigations have been conducted in the discovery of alternative non-invasive routes and/or delivery systems for biopharmaceuticals and ATPMs, and the results are promising, with medicines already approved for administration by non-parenteral routes. This special issue aims to update the state of the art of the latest developments in the formulation of biopharmaceuticals and ATPMs.

Dr. Ana Catarina Silva
Prof. Dr. José Manuel Sousa Lobo
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

  • advanced therapy medicinal products
  • biopharmaceuticals
  • biologics
  • biological medicines
  • biosimilar medicines
  • cell therapy
  • gene delivery
  • pharmaceutical biotechnology
  • pharmaceutical technology
  • protein delivery
  • regenerative medicine
  • tissue-engineering

Published Papers (2 papers)

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15 pages, 3718 KiB  
Article
l-Asparaginase Type II from Fusarium proliferatum: Heterologous Expression and In Silico Analysis
by Samuel Leite Cardoso, Paula Monteiro Souza, Kelly Rodrigues, Isabella de Souza Mota, Edivaldo Ferreira Filho, Léia Cecilia de Lima Fávaro, Felipe Saldanha-Araujo, Mauricio Homem-de-Mello, Adalberto Pessoa, Dâmaris Silveira, Yris Maria Fonseca-Bazzo and Pérola Oliveira Magalhães
Pharmaceutics 2023, 15(9), 2352; https://doi.org/10.3390/pharmaceutics15092352 - 20 Sep 2023
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Abstract
The search for new drug-producing microorganisms is one of the most promising situations in current world scientific scenarios. The use of molecular biology as well as the cloning of protein and compound genes is already well established as the gold standard method of [...] Read more.
The search for new drug-producing microorganisms is one of the most promising situations in current world scientific scenarios. The use of molecular biology as well as the cloning of protein and compound genes is already well established as the gold standard method of increasing productivity. Aiming at this increase in productivity, this work aims at the cloning, purification and in silico analysis of l-asparaginase from Fusarium proliferatum in Komagataella phaffii (Pichia pastoris) protein expression systems. The l-asparaginase gene (NCBI OQ439985) has been cloned into Pichia pastoris strains. Enzyme production was analyzed via the quantification of aspartic B-hydroxamate, followed by purification on a DEAE FF ion exchange column. The in silico analysis was proposed based on the combined use of various technological tools. The enzymatic activity found intracellularly was 2.84 IU/g. A purification factor of 1.18 was observed. The in silico analysis revealed the position of five important amino acid residues for enzymatic activity, and likewise, it was possible to predict a monomeric structure with a C-score of 1.59. The production of the enzyme l-asparaginase from F. proliferatum in P. pastoris was demonstrated in this work, being of great importance for the analysis of new methodologies in search of the production of important drugs in therapy. Full article
(This article belongs to the Special Issue Formulation of Biopharmaceuticals and Advanced Therapy Medicinal Products (ATMPs))
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11 pages, 561 KiB  
Article
Biologics for Inflammatory Bowel Disease in Clinical Practice: A Calabria (Southern Italy) Prospective Pharmacovigilance Study
by Martina Tallarico, Caterina Palleria, Livia Ruffolo, Rocco Spagnuolo, Maria Diana Naturale, Adele Emanuela De Francesco, Caterina De Sarro, Rossella Romeo, Rita Citraro, Patrizia Doldo, Ludovico Abenavoli, Luca Gallelli, Francesco Luzza, Antonio Leo and Giovambattista De Sarro
Pharmaceutics 2022, 14(11), 2449; https://doi.org/10.3390/pharmaceutics14112449 - 13 Nov 2022
Cited by 1 | Viewed by 1535
Abstract
Background: The use of immune-modifying biological agents has markedly changed the clinical course and the management of Inflammatory bowel diseases (IBDs). Active post-marketing surveillance programs are fundamental to early recognize expected and unexpected adverse events (AEs), representing a powerful tool to better determine [...] Read more.
Background: The use of immune-modifying biological agents has markedly changed the clinical course and the management of Inflammatory bowel diseases (IBDs). Active post-marketing surveillance programs are fundamental to early recognize expected and unexpected adverse events (AEs), representing a powerful tool to better determine the safety profiles of biologics in a real-world setting. Methods: This study aimed to identify the occurrence of AEs and therapeutic failures linked to biological drugs used in gastroenterology units during a prospective pharmacovigilance program in Southern Italy. Patients affected by IBDs and treated with a biologic agent, from 1 January 2019, to 31 December 2021 (study period) in three gastroenterology units were enrolled. Results: Overall, 358 patients with a diagnosis of active Crohn’s disease or ulcerative colitis satisfying inclusion criteria have been enrolled. Infliximab (IFX) was the most administered drug at the index date (214; 59.8%), followed by Adalimumab (ADA; 89; 24.9%), Golimumab (GOL; 37; 10.3%), Vedolizumab (VDZ; 17; 4.7%) and Ustekimumab (UST; 1; 0.3%). Seventy-three patients (20.4%) experienced at least one AE, while 62 patients (17.3%) had therapeutic ineffectiveness. No serious AEs were reported in the follow-up period in the enrolled patients. AEs have been described with IFX (50/214; p = 0.47), GOL (7/37; p = 0.78), ADA (13/89; p = 0.18), and VDZ (3/17; p = 0.52), no AEs have been noticed with UST (0/1). Conclusions: Based on the low rate of AEs observed and withdrawal from treatment, our data seem to corroborate the favorable beneficial/risk profile of biologics for IBDs. Full article
(This article belongs to the Special Issue Formulation of Biopharmaceuticals and Advanced Therapy Medicinal Products (ATMPs))
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