Quality by Design thinking in the development of long-acting injectable PLGA/PLA-based microspheres for peptide and protein drug delivery

Research output: Contribution to journalJournal articleResearchpeer-review

Standard

Quality by Design thinking in the development of long-acting injectable PLGA/PLA-based microspheres for peptide and protein drug delivery. / Zhang, Chengqian; Yang, Liang; Wan, Feng; Bera, Hriday; Cun, Dongmei; Rantanen, Jukka; Yang, Mingshi.

In: International Journal of Pharmaceutics, Vol. 585, 119441, 19.05.2020.

Research output: Contribution to journalJournal articleResearchpeer-review

Harvard

Zhang, C, Yang, L, Wan, F, Bera, H, Cun, D, Rantanen, J & Yang, M 2020, 'Quality by Design thinking in the development of long-acting injectable PLGA/PLA-based microspheres for peptide and protein drug delivery', International Journal of Pharmaceutics, vol. 585, 119441. https://doi.org/10.1016/j.ijpharm.2020.119441

APA

Zhang, C., Yang, L., Wan, F., Bera, H., Cun, D., Rantanen, J., & Yang, M. (2020). Quality by Design thinking in the development of long-acting injectable PLGA/PLA-based microspheres for peptide and protein drug delivery. International Journal of Pharmaceutics, 585, [119441]. https://doi.org/10.1016/j.ijpharm.2020.119441

Vancouver

Zhang C, Yang L, Wan F, Bera H, Cun D, Rantanen J et al. Quality by Design thinking in the development of long-acting injectable PLGA/PLA-based microspheres for peptide and protein drug delivery. International Journal of Pharmaceutics. 2020 May 19;585. 119441. https://doi.org/10.1016/j.ijpharm.2020.119441

Author

Zhang, Chengqian ; Yang, Liang ; Wan, Feng ; Bera, Hriday ; Cun, Dongmei ; Rantanen, Jukka ; Yang, Mingshi. / Quality by Design thinking in the development of long-acting injectable PLGA/PLA-based microspheres for peptide and protein drug delivery. In: International Journal of Pharmaceutics. 2020 ; Vol. 585.

Bibtex

@article{c8565d4d08f5479bb85dcdaeb7ba74c4,
title = "Quality by Design thinking in the development of long-acting injectable PLGA/PLA-based microspheres for peptide and protein drug delivery",
abstract = "Adopting the Quality by Design (QbD) approach in the drug development process has transformed from 'nice-to-do' into a crucial and required part of the development, ensuring the quality of pharmaceutical products throughout their whole life cycle. This review is discussing the implementation of the QbD thinking into the production of long-acting PLGA/PLA-based injectable microspheres for the therapeutic peptide and protein delivery. Various key elements of the QbD approaches are initially elaborated using Bydureon{\circledR}, a commercial product of long-acting PLGA/PLA-based injectable microspheres, as a classical example. Subsequently, the factors influencing the release patterns and the stability of the peptide and protein drugs are discussed. This is followed by a summary of the state-of-the-art of manufacturing long-acting PLGA/PLA-based injectable microspheres and the related process parameters. Finally, a landscape of generic product development of long-acting injectable (LAI) PLGA/PLA-based microspheres is reviewed including some major challenges in the field.",
author = "Chengqian Zhang and Liang Yang and Feng Wan and Hriday Bera and Dongmei Cun and Jukka Rantanen and Mingshi Yang",
note = "Copyright {\circledC} 2020. Published by Elsevier B.V.",
year = "2020",
month = "5",
day = "19",
doi = "10.1016/j.ijpharm.2020.119441",
language = "English",
volume = "585",
journal = "International Journal of Pharmaceutics",
issn = "0378-5173",
publisher = "Elsevier",

}

RIS

TY - JOUR

T1 - Quality by Design thinking in the development of long-acting injectable PLGA/PLA-based microspheres for peptide and protein drug delivery

AU - Zhang, Chengqian

AU - Yang, Liang

AU - Wan, Feng

AU - Bera, Hriday

AU - Cun, Dongmei

AU - Rantanen, Jukka

AU - Yang, Mingshi

N1 - Copyright © 2020. Published by Elsevier B.V.

PY - 2020/5/19

Y1 - 2020/5/19

N2 - Adopting the Quality by Design (QbD) approach in the drug development process has transformed from 'nice-to-do' into a crucial and required part of the development, ensuring the quality of pharmaceutical products throughout their whole life cycle. This review is discussing the implementation of the QbD thinking into the production of long-acting PLGA/PLA-based injectable microspheres for the therapeutic peptide and protein delivery. Various key elements of the QbD approaches are initially elaborated using Bydureon®, a commercial product of long-acting PLGA/PLA-based injectable microspheres, as a classical example. Subsequently, the factors influencing the release patterns and the stability of the peptide and protein drugs are discussed. This is followed by a summary of the state-of-the-art of manufacturing long-acting PLGA/PLA-based injectable microspheres and the related process parameters. Finally, a landscape of generic product development of long-acting injectable (LAI) PLGA/PLA-based microspheres is reviewed including some major challenges in the field.

AB - Adopting the Quality by Design (QbD) approach in the drug development process has transformed from 'nice-to-do' into a crucial and required part of the development, ensuring the quality of pharmaceutical products throughout their whole life cycle. This review is discussing the implementation of the QbD thinking into the production of long-acting PLGA/PLA-based injectable microspheres for the therapeutic peptide and protein delivery. Various key elements of the QbD approaches are initially elaborated using Bydureon®, a commercial product of long-acting PLGA/PLA-based injectable microspheres, as a classical example. Subsequently, the factors influencing the release patterns and the stability of the peptide and protein drugs are discussed. This is followed by a summary of the state-of-the-art of manufacturing long-acting PLGA/PLA-based injectable microspheres and the related process parameters. Finally, a landscape of generic product development of long-acting injectable (LAI) PLGA/PLA-based microspheres is reviewed including some major challenges in the field.

U2 - 10.1016/j.ijpharm.2020.119441

DO - 10.1016/j.ijpharm.2020.119441

M3 - Journal article

C2 - 32442645

VL - 585

JO - International Journal of Pharmaceutics

JF - International Journal of Pharmaceutics

SN - 0378-5173

M1 - 119441

ER -

ID: 242473034