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Bioengineering
Special Issues
Advanced Therapeutics Processing and Manufacturing
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Advanced Therapeutics Processing and Manufacturing

A special issue of Bioengineering (ISSN 2306-5354).

Deadline for manuscript submissions: closed (30 November 2022) | Viewed by 12361

Special Issue Editors

Dr. João Henrique Picado Madalena Santos

E-Mail Website1 Website2
Guest Editor
School of Pharmaceutical Sciences, University of São Paulo, São Paulo, Brazil
Interests: downstream processing; alternative solvents; biopharmaceutical process development; nanobiotechnology
Special Issues, Collections and Topics in MDPI journals
Prof. Dr. Carlota O. Rangel-Yagui

E-Mail Website
Guest Editor
Department of Pharmaceutical and Biochemical Technology University of São Paulo, São Paulo, Brazil
Interests: pegylation of protein drugs; nanobiotechnology; self-aggregated nanostructures for drug delivery; polymersomes; polymeric micelles; PEG-based nanostructures; protein purification
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

We are pleased to announce a novel Special Issue in Bioengineering focusing on “Advanced Therapeutics Processing and Manufacturing”. This Special Issue covers research on bioprocesses for the generation of advanced therapeutics, such as targeted drug delivery, cellular and genetic therapies, follow-on biologics (biosimilars and biobetters), personalized medicines, nanomedicines, and combination therapies, as well as pharmacology, toxicology and drug discovery.

Authors are invited to contribute original research papers, review articles, and short communications focusing on the process development and manufacturing of advanced therapeutics for biopharmaceutical applications. Our intention with this Special Issue is to address the key challenges and improvements for implementing novel technologies and process unit operations for this class of biologics, connecting scientific academic knowledge to the biopharma industry.

Dr. João H. P. M. Santos
Prof. Dr. Carlota O. Rangel-Yagui
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. Bioengineering 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 2700 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

  • drug delivery
  • cellular therapy
  • gene therapy
  • follow-on biologics
  • biosimilars
  • biobetters
  • bioconjugates
  • personalized medicines
  • nanomedicines
  • drug discovery
  • bioprocess
  • manufacturing

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Further information on MDPI's Special Issue polices can be found here.

Published Papers (4 papers)

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Research

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18 pages, 6238 KiB  
Article
Doxorubicin and Quercetin Double Loading in Modified MCM-41 Lowered Cardiotoxicity in H9c2 Cardioblast Cells In Vitro
by Christina Voycheva, Teodora Popova, Marta Slavkova, Virginia Tzankova, Denitsa Stefanova, Diana Tzankova, Ivanka Spassova, Daniela Kovacheva and Borislav Tzankov
Bioengineering 2023, 10(6), 637; https://doi.org/10.3390/bioengineering10060637 - 24 May 2023
Cited by 2 | Viewed by 1762
Abstract
Background: One of the therapeutic limitations of the use of doxorubicin (DOX) as an anticancer drug is its cardiotoxicity. Its hydrophilicity also causes difficulties in achieving sustained release. The simultaneous delivery with the well-known natural antioxidant quercetin could ameliorate its cardiotoxicity. Thus, the [...] Read more.
Background: One of the therapeutic limitations of the use of doxorubicin (DOX) as an anticancer drug is its cardiotoxicity. Its hydrophilicity also causes difficulties in achieving sustained release. The simultaneous delivery with the well-known natural antioxidant quercetin could ameliorate its cardiotoxicity. Thus, the main aim of this work is to study the potential of carboxylated and non-carboxylated mesoporous silica MCM-41 nanoparticles for double loading of the hydrophilic doxorubicin hydrochloride and hydrophobic quercetin (Q) in one nanocarrier with a modified release pattern to reduce the cardiotoxic side effects of doxorubicin in vitro. Methods: The methods included the modification of MCM-41, single and double loading of modified and non-modified MCM-41, physicochemical characterization, in vitro release tests and kinetic study, and in vitro cell viability studies. Results: Doxorubicin and quercetin were successfully double-loaded with encapsulation efficiency (EE) of 43 ± 4.1% and 37 ± 4.5%, respectively, in native MCM-41. The post-synthetic carboxylation led to 49 ± 4.3% EE (DOX) and 36 ± 4.0% (Q) and double lowering of the cardiotoxicity on H9c2 (IC50 = 5.96 µm). Sustained release profiles over 72 h were achieved. Conclusions: A successful procedure was proposed for the efficient double loading of a hydrophilic drug and a hydrophobic drug. The carboxy-modified double-loaded nanosystems demonstrate a decreased in vitro cardiotoxicity of doxorubicin and can be considered as a potential chemotherapeutic formulation. Full article
(This article belongs to the Special Issue Advanced Therapeutics Processing and Manufacturing)
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14 pages, 3917 KiB  
Article
Rapid Identification of Chinese Hamster Ovary Cell Apoptosis and Its Potential Role in Process Robustness Assessment
by Shang Xiao, Qiang Li, Jinlong Jiang, Chengxiao Huo, Hao Chen and Meijin Guo
Bioengineering 2023, 10(3), 357; https://doi.org/10.3390/bioengineering10030357 - 14 Mar 2023
Cited by 1 | Viewed by 2002
Abstract
Currently, the assessment of process robustness is often time-consuming, labor-intensive, and material-intensive using process characterization studies. Therefore, a simple and time-saving method is highly needed for the biopharmaceutical industry. Apoptosis is responsible for 80% of Chinese hamster ovary (CHO) cell deaths and affects [...] Read more.
Currently, the assessment of process robustness is often time-consuming, labor-intensive, and material-intensive using process characterization studies. Therefore, a simple and time-saving method is highly needed for the biopharmaceutical industry. Apoptosis is responsible for 80% of Chinese hamster ovary (CHO) cell deaths and affects the robustness of the cell culture process. This study’s results showed that a more robust process can support cells to tolerate apoptosis for a longer time, suggesting that the robustness of the process could be judged by the ability of cells to resist apoptosis. Therefore, it is necessary to establish a rapid method to detect the apoptosis of CHO cells. In trying to establish a new method for detecting apoptosis in large-scale cell cultures, glucose withdrawal was studied, and the results showed that CHO cells began to apoptose after glucose was consumed. Then, the concentration of extracellular potassium increased, and a prolongation of apoptosis time was observed. Further study results showed that the process with poor robustness was associated with a higher proportion of apoptosis and extracellular potassium concentration, so potassium could be used as a biochemical index of apoptosis. The strategy we present may be used to expedite the assessment of process robustness to obtain a robust cell culture process for other biologics. Full article
(This article belongs to the Special Issue Advanced Therapeutics Processing and Manufacturing)
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14 pages, 871 KiB  
Article
Scale-Up of Capsular Polysaccharide Production Process by Haemophilus influenzae Type b Using kLa Criterion
by Omar Pillaca-Pullo, Lucas Dias Vieira and Mickie Takagi
Bioengineering 2022, 9(9), 415; https://doi.org/10.3390/bioengineering9090415 - 25 Aug 2022
Cited by 2 | Viewed by 2653
Abstract
Polyribosyl-ribitol-phosphate (PRP) from Haemophilus influenzae type b (Hib) is an active immunizing molecule used in the production of the vaccine against H. influenzae, and industrial production could contribute to satisfying a world demand especially in developing countries. In this sense, the aim [...] Read more.
Polyribosyl-ribitol-phosphate (PRP) from Haemophilus influenzae type b (Hib) is an active immunizing molecule used in the production of the vaccine against H. influenzae, and industrial production could contribute to satisfying a world demand especially in developing countries. In this sense, the aim of this study was to establish a scale-up process using the constant oxygen mass transfer coefficient (kLa) such as the criterion for production of PRP in three different sizes of bioreactor systems. Three different kLa values (24, 52 and 80 h−1) were evaluated in which the biological influence in a 1.5 L bioreactor and 52 h−1 was selected to scale-up the production process until a 75 L pilot-scale bioreactor was achieved. Finally, the fed-batch phase was started under a dissolved oxygen concentration (pO2) at 30% of the saturation in the 75 L bioreactor to avoid oxygen limitation; the performance of production presented high efficiency (9.0 g/L DCW-dry cell weight and 1.4 g/L PRP) in comparison with previous scale-up studies. The yields, productivity and kinetic behavior were similar in the three-size bioreactor systems in the batch mode indicating that kLa is possible to use for PRP production at large scales. This process operated under two stages and successfully produced DCW and PRP in the pilot scale and could be beneficial for future bioprocess operations that may lead to higher production and less operative cost. Full article
(This article belongs to the Special Issue Advanced Therapeutics Processing and Manufacturing)
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Review

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29 pages, 6104 KiB  
Review
Metallic Microneedles for Transdermal Drug Delivery: Applications, Fabrication Techniques and the Effect of Geometrical Characteristics
by Nikoletta Sargioti, Tanya J. Levingstone, Eoin D. O’Cearbhaill, Helen O. McCarthy and Nicholas J. Dunne
Bioengineering 2023, 10(1), 24; https://doi.org/10.3390/bioengineering10010024 - 23 Dec 2022
Cited by 16 | Viewed by 4950
Abstract
Current procedures for transdermal drug delivery (TDD) have associated limitations including poor administration of nucleic acid, small or large drug molecules, pain and stress for needle phobic people. A painless micro-sized device capable of delivering drugs easily and efficiently, eliminating the disadvantages of [...] Read more.
Current procedures for transdermal drug delivery (TDD) have associated limitations including poor administration of nucleic acid, small or large drug molecules, pain and stress for needle phobic people. A painless micro-sized device capable of delivering drugs easily and efficiently, eliminating the disadvantages of traditional systems, has yet to be developed. While polymeric-based microneedle (MN) arrays have been used successfully and clinically as TDD systems, these devices lack mechanical integrity, piercing capacity and the ability to achieve tailored drug release into the systemic circulation. Recent advances in micro/nano fabrication techniques using Additive Manufacturing (AM), also known as 3D printing, have enabled the fabrication of metallic MN arrays, which offer the potential to overcome the limitations of existing systems. This review summarizes the different types of MNs used in TDD and their mode of drug delivery. The application of MNs in the treatment of a range of diseases including diabetes and cancer is discussed. The potential role of solid metallic MNs in TDD, the various techniques used for their fabrication, and the influence of their geometrical characteristics (e.g., shape, size, base diameter, thickness, and tip sharpness) on effective TDD are explored. Finally, the potential and the future directions relating to the optimization of metallic MN arrays for TDD are highlighted. Full article
(This article belongs to the Special Issue Advanced Therapeutics Processing and Manufacturing)
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