Continuous Pharmaceutical Manufacturing, Volume II

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Pharmaceutical Technology, Manufacturing and Devices".

Deadline for manuscript submissions: closed (20 February 2024) | Viewed by 14178

Special Issue Editors

School of Pharmacy, Faculty of Health Sciences, University of Eastern Finland, 70210 Kuopio, Finland
Interests: continuous manufacturing of tablets; Quality by Design (QbD); Design of Experiment (DoE); Process Analytical Techniques (PAT); multivariate spectral data analysis
Special Issues, Collections and Topics in MDPI journals
School of Pharmacy, Faculty of Health Sciences, University of Eastern Finland, 70210 Kuopio, Finland
Interests: pharmaceutical continuous manufacturing and process monitoring; 3D-printing of drugs

Special Issue Information

Dear Colleagues,

Pharmaceutical manufacturing is facing the greatest ideological revolution since industrial drug manufacturing. Drugs have been traditionally manufactured in batch mode, but now the continuous manufacturing has started to gain a serious interest in the pharmaceutical industry. The pharma industry is heavily regulated by authorizing bodies (FDA, EMA, etc.), but already, over a decade, regulatory bodies have enabled and even encouraged the change from batch to continuous manufacturing by publishing several guidelines on how to implement continuous manufacturing. Advantages of continuous manufacturing are indisputable. The quality by design framework provides the cornerstone for better process understanding and ultimately higher product quality for patients. New modes of manufacturing of drugs require a substantial amount of research from the pharmaceutical industry, academia, and various research institutions. This Special Issue: “Continuous Pharmaceutical Manufacturing” is intended to cover the whole spectrum of all relevant aspects of continuous manufacturing. Starting from the fundamental science of detailed phenomenon in continuous manufacturing and ending in how applied science can put continuous manufacturing into practice.

Dr. Ossi Korhonen
Dr. Tuomas Ervasti
Guest Editors

Manuscript Submission Information

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Keywords

  • continuous manufacturing of pharmaceuticals
  • Quality by Design
  • risk assessment in continuous manufacturing
  • Design of Experiment in continuous manufacturing
  • Design Space
  • Process Analytical Techniques (PAT) in continuous manufacturing
  • real-time process monitoring
  • data analysis of process data
  • process simulations
  • process control and automation

Published Papers (3 papers)

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Research

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18 pages, 6077 KiB  
Article
Towards the Continuous Manufacturing of Liquisolid Tablets Containing Simethicone and Loperamide Hydrochloride with the Use of a Twin-Screw Granulator
by Daniel Zakowiecki, Margarethe Richter, Ceren Yuece, Annika Voelp, Maximilian Ries, Markos Papaioannou, Peter Edinger, Tobias Hess, Krystyna Mojsiewicz-Pieńkowska and Krzysztof Cal
Pharmaceutics 2023, 15(4), 1265; https://doi.org/10.3390/pharmaceutics15041265 - 18 Apr 2023
Viewed by 1784
Abstract
Continuous manufacturing is becoming the new technological standard in the pharmaceutical industry. In this work, a twin-screw processor was employed for the continuous production of liquisolid tablets containing either simethicone or a combination of simethicone with loperamide hydrochloride. Both active ingredients present major [...] Read more.
Continuous manufacturing is becoming the new technological standard in the pharmaceutical industry. In this work, a twin-screw processor was employed for the continuous production of liquisolid tablets containing either simethicone or a combination of simethicone with loperamide hydrochloride. Both active ingredients present major technological challenges, as simethicone is a liquid, oily substance, and loperamide hydrochloride was used in a very small amount (0.27% w/w). Despite these difficulties, the use of porous tribasic calcium phosphate as a carrier and the adjustment of the settings of the twin-screw processor enabled the optimization of the characteristics of the liquid-loaded powders and made it possible to efficiently produce liquisolid tablets with advantages in physical and functional properties. The application of chemical imaging by means of Raman spectroscopy allowed for the visualization of differences in the distribution of individual components of the formulations. This proved to be a very effective tool for identifying the optimum technology to produce a drug product. Full article
(This article belongs to the Special Issue Continuous Pharmaceutical Manufacturing, Volume II)
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14 pages, 3845 KiB  
Article
Continuous Affinity Purification of Adeno-Associated Virus Using Periodic Counter-Current Chromatography
by João P. Mendes, Magnus Bergman, Anita Solbrand, Cristina Peixoto, Manuel J. T. Carrondo and Ricardo J. S. Silva
Pharmaceutics 2022, 14(7), 1346; https://doi.org/10.3390/pharmaceutics14071346 - 25 Jun 2022
Cited by 9 | Viewed by 2669
Abstract
Replacing batch unit operations of biopharmaceuticals by continuous manufacturing is a maturing concept, with periodic counter-current chromatography (PCC) favoured to replace batch chromatography. Continuous affinity capture of adeno-associated virus (AAV) using PCC has the potential to cope with the high doses required for [...] Read more.
Replacing batch unit operations of biopharmaceuticals by continuous manufacturing is a maturing concept, with periodic counter-current chromatography (PCC) favoured to replace batch chromatography. Continuous affinity capture of adeno-associated virus (AAV) using PCC has the potential to cope with the high doses required for AAV therapies thanks to its inherent high throughput. The implementation of continuous AAV affinity capture using a four-column PCC process is described herein. First, elution buffer screening was used to optimize virus recovery. Second, breakthrough curves were generated and described using a mechanistic model, which was later used to characterize the loading zone of the PCC. The experimental runs achieved a stable cyclic steady state yielding virus recoveries in line with the optimized batch process (>82%), with almost a three-fold improvement in productivity. The PCC affinity capture process developed here can bolster further improvements to process economics and manufacturing footprint, thereby contributing to the integrated continuous manufacturing concept. Full article
(This article belongs to the Special Issue Continuous Pharmaceutical Manufacturing, Volume II)
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Review

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32 pages, 1001 KiB  
Review
Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms
by John Wahlich
Pharmaceutics 2021, 13(8), 1311; https://doi.org/10.3390/pharmaceutics13081311 - 22 Aug 2021
Cited by 11 | Viewed by 8798
Abstract
Continuous manufacturing (CM) is defined as a process in which the input material(s) are continuously fed into and transformed, and the processed output materials are continuously removed from the system. CM can be considered as matching the FDA’s so-called ‘Desired State’ of pharmaceutical [...] Read more.
Continuous manufacturing (CM) is defined as a process in which the input material(s) are continuously fed into and transformed, and the processed output materials are continuously removed from the system. CM can be considered as matching the FDA’s so-called ‘Desired State’ of pharmaceutical manufacturing in the twenty-first century as discussed in their 2004 publication on ‘Innovation and Continuous Improvement in Pharmaceutical Manufacturing’. Yet, focused attention on CM did not really start until 2014, and the first product manufactured by CM was only approved in 2015. This review describes some of the benefits and challenges of introducing a CM process with a particular focus on small molecule solid oral dosage forms. The review is a useful introduction for individuals wishing to learn more about CM. Full article
(This article belongs to the Special Issue Continuous Pharmaceutical Manufacturing, Volume II)
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