Transforming nanomedicine manufacturing toward Quality by Design and microfluidics

Research output: Contribution to journalJournal articleResearchpeer-review

Standard

Transforming nanomedicine manufacturing toward Quality by Design and microfluidics. / Colombo, Stefano; Beck-Broichsitter, Moritz; Bøtker, Johan Peter; Malmsten, Martin; Rantanen, Jukka; Bohr, Adam.

In: Advanced Drug Delivery Reviews, Vol. 128, 2018, p. 115-131.

Research output: Contribution to journalJournal articleResearchpeer-review

Harvard

Colombo, S, Beck-Broichsitter, M, Bøtker, JP, Malmsten, M, Rantanen, J & Bohr, A 2018, 'Transforming nanomedicine manufacturing toward Quality by Design and microfluidics', Advanced Drug Delivery Reviews, vol. 128, pp. 115-131. https://doi.org/10.1016/j.addr.2018.04.004

APA

Colombo, S., Beck-Broichsitter, M., Bøtker, J. P., Malmsten, M., Rantanen, J., & Bohr, A. (2018). Transforming nanomedicine manufacturing toward Quality by Design and microfluidics. Advanced Drug Delivery Reviews, 128, 115-131. https://doi.org/10.1016/j.addr.2018.04.004

Vancouver

Colombo S, Beck-Broichsitter M, Bøtker JP, Malmsten M, Rantanen J, Bohr A. Transforming nanomedicine manufacturing toward Quality by Design and microfluidics. Advanced Drug Delivery Reviews. 2018;128:115-131. https://doi.org/10.1016/j.addr.2018.04.004

Author

Colombo, Stefano ; Beck-Broichsitter, Moritz ; Bøtker, Johan Peter ; Malmsten, Martin ; Rantanen, Jukka ; Bohr, Adam. / Transforming nanomedicine manufacturing toward Quality by Design and microfluidics. In: Advanced Drug Delivery Reviews. 2018 ; Vol. 128. pp. 115-131.

Bibtex

@article{7f8ca473b1704bb9a565f529411bd320,
title = "Transforming nanomedicine manufacturing toward Quality by Design and microfluidics",
abstract = "Abstract Nanopharmaceuticals aim at translating the unique features of nano-scale materials into therapeutic products and consequently their development relies critically on the progression in manufacturing technology to allow scalable processes complying with process economy and quality assurance. The relatively high failure rate in translational nanopharmaceutical research and development, with respect to new products on the market, is at least partly due to immature bottom-up manufacturing development and resulting sub-optimal control of quality attributes in nanopharmaceuticals. Recently, quality-oriented manufacturing of pharmaceuticals has undergone an unprecedented change toward process and product development interaction. In this context, Quality by Design (QbD) aims to integrate product and process development resulting in an increased number of product applications to regulatory agencies and stronger proprietary defense strategies of process-based products. Although QbD can be applied to essentially any production approach, microfluidic production offers particular opportunities for QbD-based manufacturing of nanopharmaceuticals. Microfluidics provides unique design flexibility, process control and parameter predictability, and also offers ample opportunities for modular production setups, allowing process feedback for continuously operating production and process control. The present review aims at outlining emerging opportunities in the synergistic implementation of QbD strategies and microfluidic production in contemporary development and manufacturing of nanopharmaceuticals. In doing so, aspects of design and development, but also technology management, are reviewed, as is the strategic role of these tools for aligning nanopharmaceutical innovation, development, and advanced industrialization in the broader pharmaceutical field.",
keywords = "Manufacturing, Microfluidics, Nanomedicine, Nanopharmaceuticals, Quality by Design (QbD), Scale-up",
author = "Stefano Colombo and Moritz Beck-Broichsitter and B{\o}tker, {Johan Peter} and Martin Malmsten and Jukka Rantanen and Adam Bohr",
year = "2018",
doi = "10.1016/j.addr.2018.04.004",
language = "English",
volume = "128",
pages = "115--131",
journal = "Advanced Drug Delivery Reviews",
issn = "0169-409X",
publisher = "Elsevier",

}

RIS

TY - JOUR

T1 - Transforming nanomedicine manufacturing toward Quality by Design and microfluidics

AU - Colombo, Stefano

AU - Beck-Broichsitter, Moritz

AU - Bøtker, Johan Peter

AU - Malmsten, Martin

AU - Rantanen, Jukka

AU - Bohr, Adam

PY - 2018

Y1 - 2018

N2 - Abstract Nanopharmaceuticals aim at translating the unique features of nano-scale materials into therapeutic products and consequently their development relies critically on the progression in manufacturing technology to allow scalable processes complying with process economy and quality assurance. The relatively high failure rate in translational nanopharmaceutical research and development, with respect to new products on the market, is at least partly due to immature bottom-up manufacturing development and resulting sub-optimal control of quality attributes in nanopharmaceuticals. Recently, quality-oriented manufacturing of pharmaceuticals has undergone an unprecedented change toward process and product development interaction. In this context, Quality by Design (QbD) aims to integrate product and process development resulting in an increased number of product applications to regulatory agencies and stronger proprietary defense strategies of process-based products. Although QbD can be applied to essentially any production approach, microfluidic production offers particular opportunities for QbD-based manufacturing of nanopharmaceuticals. Microfluidics provides unique design flexibility, process control and parameter predictability, and also offers ample opportunities for modular production setups, allowing process feedback for continuously operating production and process control. The present review aims at outlining emerging opportunities in the synergistic implementation of QbD strategies and microfluidic production in contemporary development and manufacturing of nanopharmaceuticals. In doing so, aspects of design and development, but also technology management, are reviewed, as is the strategic role of these tools for aligning nanopharmaceutical innovation, development, and advanced industrialization in the broader pharmaceutical field.

AB - Abstract Nanopharmaceuticals aim at translating the unique features of nano-scale materials into therapeutic products and consequently their development relies critically on the progression in manufacturing technology to allow scalable processes complying with process economy and quality assurance. The relatively high failure rate in translational nanopharmaceutical research and development, with respect to new products on the market, is at least partly due to immature bottom-up manufacturing development and resulting sub-optimal control of quality attributes in nanopharmaceuticals. Recently, quality-oriented manufacturing of pharmaceuticals has undergone an unprecedented change toward process and product development interaction. In this context, Quality by Design (QbD) aims to integrate product and process development resulting in an increased number of product applications to regulatory agencies and stronger proprietary defense strategies of process-based products. Although QbD can be applied to essentially any production approach, microfluidic production offers particular opportunities for QbD-based manufacturing of nanopharmaceuticals. Microfluidics provides unique design flexibility, process control and parameter predictability, and also offers ample opportunities for modular production setups, allowing process feedback for continuously operating production and process control. The present review aims at outlining emerging opportunities in the synergistic implementation of QbD strategies and microfluidic production in contemporary development and manufacturing of nanopharmaceuticals. In doing so, aspects of design and development, but also technology management, are reviewed, as is the strategic role of these tools for aligning nanopharmaceutical innovation, development, and advanced industrialization in the broader pharmaceutical field.

KW - Manufacturing

KW - Microfluidics

KW - Nanomedicine

KW - Nanopharmaceuticals

KW - Quality by Design (QbD)

KW - Scale-up

U2 - 10.1016/j.addr.2018.04.004

DO - 10.1016/j.addr.2018.04.004

M3 - Journal article

VL - 128

SP - 115

EP - 131

JO - Advanced Drug Delivery Reviews

JF - Advanced Drug Delivery Reviews

SN - 0169-409X

ER -

ID: 194801740