Biomanufacturing for clinically advanced cell therapies

A Aijaz, M Li, D Smith, D Khong, C LeBlon… - Nature biomedical …, 2018 - nature.com
The achievements of cell-based therapeutics have galvanized efforts to bring cell therapies
to the market. To address the demands of the clinical and eventual commercial-scale …

Expansion of human mesenchymal stem/stromal cells (hMSCs) in bioreactors using microcarriers: lessons learnt and what the future holds

PS Couto, MC Rotondi, A Bersenev, CJ Hewitt… - Biotechnology …, 2020 - Elsevier
Human mesenchymal stem/stromal cells (hMSCs) present a key therapeutic cellular
intervention for use in cell and gene therapy (CGT) applications due to their …

[HTML][HTML] Process development for expansion of human mesenchymal stromal cells in a 50 L single-use stirred tank bioreactor

T Lawson, DE Kehoe, AC Schnitzler… - Biochemical …, 2017 - Elsevier
The application of cell-based therapeutics requires development of refined and scalable
culture processes. Stirred tank bioreactors facilitate growth of human mesenchymal stromal …

Expansion of 3D human induced pluripotent stem cell aggregates in bioreactors: bioprocess intensification and scaling-up approaches

B Abecasis, T Aguiar, É Arnault, R Costa… - Journal of …, 2017 - Elsevier
Human induced pluripotent stem cells (hiPSC) are attractive tools for drug screening and
disease modeling and promising candidates for cell therapy applications. However, to …

Scalable microcarrier-based manufacturing of mesenchymal stem/stromal cells

AM de Soure, A Fernandes-Platzgummer… - Journal of …, 2016 - Elsevier
Due to their unique features, mesenchymal stem/stromal cells (MSC) have been exploited in
clinical settings as therapeutic candidates for the treatment of a variety of diseases …

Industry 4.0: a vision for personalized medicine supply chains?

J Branke, SS Farid, N Shah - Cell and Gene Therapy Insights, 2016 - wrap.warwick.ac.uk
Industry 4.0 foresees a digital transformation of manufacturing resulting in smart factories
and supply chains. At the heart of the concept lies the vision of interconnected materials …

[HTML][HTML] Particles in biopharmaceutical formulations, part 2: an update on analytical techniques and applications for therapeutic proteins, viruses, vaccines and cells

A Roesch, S Zölls, D Stadler, C Helbig… - Journal of …, 2022 - Elsevier
Particles in biopharmaceutical formulations remain a hot topic in drug product development.
With new product classes emerging it is crucial to discriminate particulate active …

Bioprocess integration for human mesenchymal stem cells: from up to downstream processing scale-up to cell proteome characterization

B Cunha, T Aguiar, SB Carvalho, MM Silva… - Journal of …, 2017 - Elsevier
To deliver the required cell numbers and doses to therapy, scaling-up production and
purification processes (at least to the liter-scale) while maintaining cells' characteristics is …

Application of RPMI 2650 as a cell model to evaluate solid formulations for intranasal delivery of drugs

VSS Goncalves, AA Matias, J Poejo, AT Serra… - International Journal of …, 2016 - Elsevier
During the development of intranasal drug delivery systems for local/systemic effect or brain
targeting, it is necessary to assess its cytotoxicity and drug transport through nasal …

Production of oncolytic adenovirus and human mesenchymal stem cells in a single‐use, vertical‐wheel bioreactor system: impact of bioreactor design on performance …

MFQ Sousa, MM Silva, D Giroux… - Biotechnology …, 2015 - Wiley Online Library
Anchorage‐dependent cell cultures are used for the production of viruses, viral vectors, and
vaccines, as well as for various cell therapies and tissue engineering applications. Most of …