Development and optimization of microfluidic assisted manufacturing process to produce PLGA nanoparticles

Chiesa, Enrica; Bellotti, Marco; Caimi, Alessandro Ciatti; Conti, Bice; Dorati, Rossella; Conti, Michele; Auricchio, Ferdinando

doi:10.1016/j.ijpharm.2022.122368

Cited by 14 publications

(11 citation statements)

References 35 publications

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“…A rising area of research involves the design of novel microfluidic devices for precise control over fluid mixing and particle size. [154] These devices can be readily integrated within continuous manufacturing systems. Finally, new models are being developed, such as the coefficient of blending performance, to quantify the mixing quality of pharmaceutical powder mixtures when using continuous mixers.…”

Section: Blending and Mixingmentioning

confidence: 99%

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Continuous Manufacturing of Active Pharmaceutical Ingredients: Current Trends and Perspectives

Hyer,

Gregory,

Kay

et al. 2024

Adv Synth Catal

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The pharmaceutical industry has traditionally employed batch processing as a means of synthesizing active pharmaceutical ingredients (APIs) on a commercial scale. Batch manufacturing enables API synthesis in large quantities in order to meet regulations. Yet, this strategy remains cumbersome, is labor‐intensive, and creates complex logistical networks. In recent decades, batch API processing has gradually eroded American economic competitiveness and has led to the off‐shoring of API manufacturing from the United States. Today it is estimated that +80% of APIs are manufactured overseas. Meanwhile, disruptions from the Coronavirus Disease (SARS‐CoV‐2) have exacerbated weaknesses in the global supply chain, culminating with widespread shortages of critical life‐saving drugs. These shortages have emphasized the importance of reshoring drug manufacturing to the U.S. and fostered a regulatory landscape that seeks advanced methods of API manufacturing in order to bolster America’s supply chain resiliency. Recently, increased attention has been directed towards continuous drug manufacturing to enable nonstop API production within modular stand‐alone flow systems. Continuous manufacturing (CM) facilitates modular automation, offers new avenues towards process intensification, and even enables in‐line analytical monitoring from raw materials to packaged products. This strategy offers better conversion, increased safety, reduced waste, and overall cost savings versus traditional batch‐style processing. The rise of advanced API manufacturing, coupled with the current regulatory landscape, offers a rare window of opportunity to convert traditional batch pharmaceutical processes into continuous, streamlined production systems to on‐shore API manufacturing and eliminate drug shortages. This review will outline the current state‐of‐the‐art in the CM of APIs and will highlight the translation of chemistry and unit operations from batch processes to modular CM systems.

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Section: Blending and Mixingmentioning

confidence: 99%

“…One example is in the field of nanomedicine. A rising area of research involves the design of novel microfluidic devices for precise control over fluid mixing and particle size [154] . These devices can be readily integrated within continuous manufacturing systems.…”

Section: Unit Operationsmentioning

confidence: 99%

Continuous Manufacturing of Active Pharmaceutical Ingredients: Current Trends and Perspectives

Hyer,

Gregory,

Kay

et al. 2024

Adv Synth Catal

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“…The software allows us to control the following process parameters: i) type of syringes used, ii) nal formulation volume, iii) total ow rate (TFR) meaning the ow speed into the microchannel and iv) ow rate ratio between the two pumps. This in-house assembled system was validated to ensure mixing accuracy, the repeatability, and the volume accuracy [19].…”

Section: Micro Uidic Production Station For Lnpsmentioning

confidence: 99%

“…With the aim to understand the effect of the inner channel geometry, LNPs composed of DSPC and Chol at different molar ratio, 77:23 and 65:35, were produce by mixing the lipid solutions and PBS at 8 mL/min into Y-1, Y-2 and Y-3 microchannels, as performed in the previous work [19]. Different FRRs were used namely 4, 6 and 9.…”

Section: Effect Of Channels Geometrymentioning

confidence: 99%

“…Some micro uidic devices have been released on the market and they were used to produce LNPs. Our production platform was validated in term of mixing process accuracy, precision and reproducibility in our previous work [19]. In the present work the aim was to test the feasibility of the same micro uidic platform to produce LNPs by evaluating several manufacturing conditions.…”

Section: Micro Uidic Formulation Of Lipid Nanoparticlesmentioning

confidence: 99%

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Rapid-mixing production of lipid nanoparticles for biomolecules delivery

CHIESA,

Caimi,

Bellotti

et al. 2023

Preprint

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During past years, lipid nanoparticles (LNPs) have emerged as helpful tool to deliver sensible biomolecules such as protein and oligonucleotides demonstrating high efficiency in vitro and in vivo. However, the translation of these nanosystems from bench to bedside has been limited mainly because the LNPs production methods are usually associated to poor control over the lipid’s assembly and hence LNPs quality attributes. In this framework, microfluidics offers the opportunity to overcome this issue since it allows fast, reproducible, and robust LNPs production and now it is revolutionizing the R&D sections since it is the ideal choice for a rapid prototyping of a formulation. New microfluidic platforms need to be developed and customized considering the production process. Within the present work, the feasibility of producing LNPs by a brand-new microfluidic platform was demonstrated by a systematic approach. Screening design of experiment and Box-Behnken design were applied to identify the operating parameters affecting the LNPs quality. The performances of the new production platform were assessed by producing neutral, stealth, and cationic LNPs and further, several model biomolecules were successfully loaded with a high encapsulation always higher than 70%.

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