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 journal › Journal article › Research › peer-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, 2020.Research output: Contribution to journal › Journal article › Research › peer-review
Harvard
APA
Vancouver
Author
Bibtex
}
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
Y1 - 2020
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