Overview
ABSTRACT
Microfluidics is increasingly used in a wide range of fields: healthcare is no exception. In this article, the contribution of microfluidics will be illustrated and discussed throughout the various stages of drug design, from active ingredient discovery to formulation. The benefits of microfluidics in diagnostic applications will also be presented. A critical review of the current state of the art will point to future development avenues addressed by academic and industrial researchers, as well as the technological hurdles to be overcome in the years ahead.
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Read the articleAUTHORS
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Jérémie GOUYON: Senior Lecturer - Laboratory of Physical Chemistry and Microbiology for Materials and the Environment, LCPME, UMR 7564 CNRS-Université de Lorraine, Nancy, France
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Thibault ROQUES-CARMES: Senior Lecturer - Reactions and Process Engineering Laboratory, LRGP, - UMR 7274 CNRS-Université de Lorraine, Nancy, France
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Anne SAPIN-MINET: University Professor - Cibles Thérapeutiques, Formulation et Expertise préclinique du médicament, CITHEFOR, UR 3452 Université de Lorraine, Nancy, France
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Marianne PARENT: Senior Lecturer - Cibles Thérapeutiques, Formulation et Expertise préclinique du médicament, CITHEFOR, UR 3452 Université de Lorraine, Nancy, France
INTRODUCTION
Microfluidics is defined as the manipulation of small volumes of fluid (10 –9 to 10 –18 L) in channels of micrometric dimensions (< 100 μm). This change of scale not only leads to paradigm shifts in the properties of liquids, but also to the possibility of miniaturizing manufacturing, characterization, study and manipulation processes that usually occupy substantial laboratory space.
These adaptations were the subject of numerous studies initiated in the 1970s: gas chromatography separation processes, miniaturization of electrophoresis processes, applications that are now diversifying and responding to the challenges of the pharmaceutical industry in particular. Whether it's continuous flow synthesis, active ingredient screening, product quality control, innovative drug formulation or organ-on-a-chip design, microfluidics offers new constraints, but also interesting prospects: reduced volumes and reagents, process safety, dimensional control, lower costs... these are just some of the advantages investigated in this fact sheet.
Bringing a new drug to market is a long (between 10 and 20 years) and complex process. The first step is to identify and produce an active molecule (discovery phase), then the second (development phase: synthesis, formulation, evaluation) is to transform it into a product that can be approved by the health authorities and then marketed (commercialization phase). With this in mind, the advantages of microfluidics in the stages of therapeutic target identification with enzymes or cells, synthesis of active ingredients, galenic formulation, drug delivery, and also diagnostic aspects via Points-of-care (tests as close to the patient as possible) are highlighted. The different chips used (continuous flow, discontinuous flow in drops or wells, capillarity, and microneedling), as well as the level of maturity of these microtechnologies for each stage, are discussed. Challenges and limitations, such as the difficulty of miniaturizing liquid transport and detection systems, quality control, and scaling up production, are analyzed.
A glossary and table of acronyms are provided at the end of the article.
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KEYWORDS
microfluidics | pharmaceutical development | diagnosis | organs-on-chip
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Microfluidics, a versatile healthcare tool
Bibliography
Standards and norms
- Microfluidic devices – Interoperability requirements concerning dimensions, connections and initial classification of devices - ISO 22916 - 2022
- Automated liquid handling systems – Part 1: Vocabulary and general requirements - ISO 23783-1 - 2022
- Microfluidics – Vocabulary - ISO 10991 - 2023
- Automated liquid handling systems – Uncertainty of measurement procedures - ISO/TR 6037 - 2024
Regulations
Commission Directive (EU) 2017/1572 of September 15, 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards principles and guidelines of good manufacturing practice for medicinal products for human use (CELEX: 32017L1572)
Directory
European EMPIR project "Establishing metrology standards in microfluidic devices" (MFMET, 20NRM02): https://mfmet.eu
GDR Micro and Nanofluidics : https://www.gdrmicrofluidique.com
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