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 …

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 …

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 …

Preparation and optimization of an eggshell membrane-based biomaterial for GTR applications

L Kalluri, JA Griggs, AV Janorkar, X Xu, R Chandran… - Dental Materials, 2024 - Elsevier
Abstract Objectives Guided Tissue Regeneration (GTR) is a popular clinical procedure for
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 …

[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 …

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 …

Climbing the mountain: experimental design for the efficient optimization of stem cell bioprocessing

D Toms, R Deardon, M Ungrin - Journal of biological engineering, 2017 - Springer
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.” …

Stem cell bioprocess engineering towards cGMP production and clinical applications

S Sart, YJ Schneider, Y Li, SN Agathos - Cytotechnology, 2014 - Springer
Stem cells, including mesenchymal stem cells and pluripotent stem cells, are becoming an
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 …