Allogeneic cell therapy manufacturing: process development technologies and facility design options

S Abbasalizadeh, M Pakzad, JMS Cabral… - Expert Opinion on …, 2017 - Taylor & Francis
Introduction: Currently, promising outcomes from clinical trials of allogeneic cells, especially
allogeneic mesenchymal stromal cells, fibroblasts, keratinocytes, and human cardiac stem …

Concise review: guidance in developing commercializable autologous/patient-specific cell therapy manufacturing

S Eaker, M Armant, H Brandwein… - Stem cells …, 2013 - academic.oup.com
Cell therapy is poised to play an enormous role in regenerative medicine. However, little
guidance is being made available to academic and industrial entities in the start-up phase …

Cell therapy products are revolutionizing multiple therapeutic areas; to maintain this pace of innovation, manufacturing solutions must adapt

E Abraham, N Trainor, N Ostrout, MM Hewitt - Current Opinion in …, 2021 - Elsevier
Although cell therapies continue to reshape multiple therapeutics areas, the field is still
grappling with how to best manufacture therapies. Allogeneic therapies are currently …

[HTML][HTML] Commercial scale manufacturing of allogeneic cell therapy

GM Pigeau, E Csaszar, A Dulgar-Tulloch - Frontiers in medicine, 2018 - frontiersin.org
Allogeneic cell therapy products are generating encouraging clinical and pre-clinical results.
Pluripotent stem cell (PSC) derived therapies, in particular, have substantial momentum and …

[PDF][PDF] Mastering industrialization of cell therapy products

JP Prieels, P Stragier, F Lesage… - BioProcess …, 2012 - eu-assets.contentstack.com
Incomes currently generated by the global cell therapy market are estimated to be~ US $400
million. That value represents 10 main products, some of which have been on the market …

Platforms for manufacturing allogeneic, autologous and iPSC cell therapy products: an industry perspective

E Abraham, BB Ahmadian, K Holderness… - … and manufacturing of …, 2018 - Springer
As cell therapy processes mature from benchtop research protocols to industrial processes
capable of manufacturing market-relevant numbers of doses, new cell manufacturing …

GMP facilities for clinical cell therapy product manufacturing: a brief review of requirements and design considerations

HR Aghayan, B Arjmand, SR Burger - … alternative sources of fetal stem cells, 2016 - Springer
The field of cell-based therapies is evolving quickly, and its potential for transformational
new treatment modalities has generated great excitement in the scientific community. In the …

[PDF][PDF] Current understanding and challenges in bioprocessing of stem cell-based therapies for regenerative medicine

E Ratcliffe, RJ Thomas, DJ Williams - British medical bulletin, 2011 - researchgate.net
Background: A novel manufacturing industry is emerging to translate unique cellular therapy
bioprocesses to robust, scaled manufacturing production for successful clinical translation …

Scalable manufacture for cell therapy needs

QA Rafiq, TRJ Heathman, K Coopman… - … Operation and Novel …, 2016 - Wiley Online Library
Stem cell therapies represent a significant opportunity, with the potential to provide global
health and wealth benefits. The scalable manufacture of stem cell therapies will be …

Storage and delivery of stem cells for cellular therapies

HE Jesson, NJ Robinson, N Medcalf… - Stem Cell Manufacturing, 2016 - Elsevier
One of the biggest challenges for the commercialization of stem cell therapies (SCTs) is
securing the therapeutic potential of the cells. This requires cellular preservation to be …