Quality cell therapy manufacturing by design
YY Lipsitz, NE Timmins, PW Zandstra - Nature biotechnology, 2016 - nature.com
Transplantation of live cells as therapeutic agents is poised to offer new treatment options for
a wide range of acute and chronic diseases. However, the biological complexity of cells has …
a wide range of acute and chronic diseases. However, the biological complexity of cells has …
Design of experiments and design space approaches in the pharmaceutical bioprocess optimization
A Kasemiire, HT Avohou, C De Bleye, PY Sacre… - European Journal of …, 2021 - Elsevier
The optimization of pharmaceutical bioprocesses suffers from several challenges like
complexity, upscaling costs, regulatory approval, leading to the risk of delivering …
complexity, upscaling costs, regulatory approval, leading to the risk of delivering …
Clever experimental designs: Shortcuts for better iPSC differentiation
R Yasui, K Sekine, H Taniguchi - Cells, 2021 - mdpi.com
For practical use of pluripotent stem cells (PSCs) for disease modelling, drug screening, and
regenerative medicine, the cell differentiation process needs to be properly refined to …
regenerative medicine, the cell differentiation process needs to be properly refined to …
Preparation and optimization of an eggshell membrane-based biomaterial for GTR applications
Abstract Objectives Guided Tissue Regeneration (GTR) is a popular clinical procedure for
periodontal tissue regeneration. However, its key component, the barrier membrane, is …
periodontal tissue regeneration. However, its key component, the barrier membrane, is …
Addressing the manufacturing challenges of cell-based therapies
M de Almeida Fuzeta, AD de Matos Branco… - Current applications of …, 2020 - Springer
Exciting developments in the cell therapy field over the last decades have led to an
increasing number of clinical trials and the first cell products receiving marketing …
increasing number of clinical trials and the first cell products receiving marketing …
[HTML][HTML] From production to patient: challenges and approaches for delivering cell therapies
K Coopman, N Medcalf - 2014 - europepmc.org
The cell therapy industry is rapidly growing with several new products approved for clinical
use over the past few years and many more currently in clinical trials. Nonetheless, a …
use over the past few years and many more currently in clinical trials. Nonetheless, a …
Application of a quality by design approach to the cell culture process of monoclonal antibody production, resulting in the establishment of a design space
H Nagashima, A Watari, Y Shinoda, H Okamoto… - Journal of …, 2013 - Elsevier
This case study describes the application of Quality by Design elements to the process of
culturing Chinese hamster ovary cells in the production of a monoclonal antibody. All steps …
culturing Chinese hamster ovary cells in the production of a monoclonal antibody. All steps …
Climbing the mountain: experimental design for the efficient optimization of stem cell bioprocessing
Abstract “To consult the statistician after an experiment is finished is often merely to ask him
to conduct a post mortem examination. He can perhaps say what the experiment died of.” …
to conduct a post mortem examination. He can perhaps say what the experiment died of.” …
Stem cell bioprocess engineering towards cGMP production and clinical applications
Stem cells, including mesenchymal stem cells and pluripotent stem cells, are becoming an
indispensable tool for various biomedical applications including drug discovery, disease …
indispensable tool for various biomedical applications including drug discovery, disease …
Systematic optimization of culture media for maintenance of human induced pluripotent stem cells using the response surface methodology
SM Mirkalaei, S Farivar - Heliyon, 2024 - cell.com
The application of human induced pluripotent stem cells (hiPSCs) provides tremendous
opportunities in cell therapy. However, culturing these cells faces many practical challenges …
opportunities in cell therapy. However, culturing these cells faces many practical challenges …