Quality by design (QbD) approach in marketing authorization procedures of non-biological complex drugs: a critical evaluation
DM Zagalo, J Sousa, S Simões - European Journal of Pharmaceutics and …, 2022 - Elsevier
The emergence of innovator-driven complex drug products, such as Non-Biological
Complex Drugs (NBCDs), has provided disruptive advances in the Nanotechnology and …
Complex Drugs (NBCDs), has provided disruptive advances in the Nanotechnology and …
Critical analysis of cGMP large-scale expansion process in bioreactors of human induced pluripotent stem cells in the framework of quality by design
A Rivera-Ordaz, V Peli, P Manzini, M Barilani, L Lazzari - BioDrugs, 2021 - Springer
Human induced pluripotent stem cells (hiPSCs) are manufactured as advanced therapy
medicinal products for tissue replacement applications. With this aim, the feasibility of hiPSC …
medicinal products for tissue replacement applications. With this aim, the feasibility of hiPSC …
Quality by design in pharmaceutical development
R Kumar, A Mittal, MP Kulkarni - … and drug delivery: An application guide …, 2022 - Springer
Abstract Design and formulation of an ideal pharmaceutical product is a tedious job for a
formulator as it comprises multiple objectives. The traditional method followed for years is …
formulator as it comprises multiple objectives. The traditional method followed for years is …
PEGylation versus glycosylation: effect on the thermodynamics and thermostability of crisantaspase
K Torres‐Obreque, EK Kleingesinds… - Preparative …, 2024 - Taylor & Francis
Thermostability is an important and desired feature of therapeutic proteins and is critical for
the success or failure of protein drugs development. It can be increased by PEGylation …
the success or failure of protein drugs development. It can be increased by PEGylation …
Employing QbD strategies to assess the impact of cell viability and density on the primary recovery of monoclonal antibodies
OJ Wohlenberg, C Kortmann, KV Meyer… - Engineering in Life …, 2023 - Wiley Online Library
Abstract Quality by Design (QbD) is one of the most important tools for the implementation of
Process Analytical Technology (PAT) in biopharmaceutical production. For optimal …
Process Analytical Technology (PAT) in biopharmaceutical production. For optimal …
[HTML][HTML] Biotechnological Drug Development—The Role of Proteins, Genes, In-Silico, and Stem Cells in Designing Models for Enhanced Drug Discovery
TA Suleiman, AC Francis, A Ibrahim… - Open Access Library …, 2023 - scirp.org
The application of biotechnology in drug discovery has been discovered to be a promising
and resourceful approach for the discovery of novel therapeutic candidates that comes with …
and resourceful approach for the discovery of novel therapeutic candidates that comes with …
Applications of Quality by Design in Pharmaceutical Product Development Lifecycle
A Kumari, G Aggarwal, A Kaur - Introduction to Quality by Design (QbD) …, 2024 - Springer
Abstract Quality by Design (QbD) is a contemporary methodology that guarantees the quality
of pharmaceuticals by implementing a methodical and evidence-based approach …
of pharmaceuticals by implementing a methodical and evidence-based approach …
Predicting the outcome of granulation and tableting processes using different artificial intelligence methods
N Sokolović, M Ajanović, S Badić, M Banjanin… - … 2019: Proceedings of …, 2020 - Springer
Artificial intelligence methods offer a modern approach in solving different problems in the
field of pharmacy, especially in the area of pharmaceutical technology. The main goal of this …
field of pharmacy, especially in the area of pharmaceutical technology. The main goal of this …
Entwicklung eines QbD-Konzepts für einen biopharmazeutischen Antikörper-Herstellungsprozess
OJ Wohlenberg - 2023 - repo.uni-hannover.de
Monoklonale Antikörper gewinnen aufgrund ihrer vielseitigen Anwendungsbereiche immer
weiter an Relevanz. Sie werden sowohl in der Diagnostik als auch in therapeutischen …
weiter an Relevanz. Sie werden sowohl in der Diagnostik als auch in therapeutischen …
[PDF][PDF] Strategic and Advancing Regulatory Science Approach in Pharmaceutical Development of Complex Generic Drug Products
DMM Zagalo - 2022 - estudogeral.uc.pt
Daniela Mariana Marques Zagalo Page 1 Daniela Mariana Marques Zagalo STRATEGIC AND
ADVANCING REGULATORY SCIENCE APPROACH IN PHARMACEUTICAL DEVELOPMENT …
ADVANCING REGULATORY SCIENCE APPROACH IN PHARMACEUTICAL DEVELOPMENT …