Stem Cell Production: Scale Up, GMP Production, Bioreactor

2021 ◽  
pp. 243-267
Author(s):  
Naseem A. Almezel
Keyword(s):  
Stem Cell ◽  
Scale Up ◽  
Production Scale ◽  
Cell Production ◽  
Gmp Production

scholarly journals Mesenchymal Stem Cell-Derived Extracellular Vesicles: Regenerative Potential and Challenges

Biology ◽  
2021 ◽  
Vol 10 (3) ◽  
pp. 172
Author(s):  
Shivkanya Fuloria ◽  
Vetriselvan Subramaniyan ◽  
Rajiv Dahiya ◽  
Sunita Dahiya ◽  
Kalvatala Sudhakar ◽  
...  
Keyword(s):  
Stem Cells ◽  
Nervous System ◽  
Stem Cell ◽  
Mesenchymal Stem Cell ◽  
Extracellular Vesicles ◽  
Scale Up ◽  
Production Technique ◽  
Production Scale ◽  
Therapeutic Benefits ◽  
Quality Production

Evidence suggests that stem cells exert regenerative potential via the release of extracellular vesicles. Mesenchymal stem cell extracellular vesicles (MSCEVs) offer therapeutic benefits for various pathophysiological ailments by restoring tissues. Facts suggest that MSCEV action can be potentiated by modifying the mesenchymal stem cells culturing methodology and bioengineering EVs. Limited clinical trials of MSCEVs have questioned their superiority, culturing quality, production scale-up and isolation, and administration format. Translation of preclinically successful MSCEVs into a clinical platform requires paying attention to several critical matters, such as the production technique, quantification/characterization, pharmacokinetics/targeting/transfer to the target site, and the safety profile. Keeping these issues as a priority, the present review was designed to highlight the challenges in translating preclinical MSCEV research into clinical platforms and provide evidence for the regenerative potential of MSCEVs in various conditions of the liver, kidney, heart, nervous system, bone, muscle, cartilage, and other organs/tissues.

Scale-up of adipose tissue-derived mesenchymal stem cell production in stirred single-use bioreactors under low-serum conditions

2014 ◽  
Vol 14 (3) ◽  
pp. 292-303 ◽  
Author(s):  
Carmen Schirmaier ◽  
Valentin Jossen ◽  
Stephan C. Kaiser ◽  
Frank Jüngerkes ◽  
Silke Brill ◽  
...  
Keyword(s):  
Adipose Tissue ◽  
Stem Cell ◽  
Mesenchymal Stem Cell ◽  
Scale Up ◽  
Cell Production ◽  
Single Use ◽  
Low Serum

scholarly journals Successful scale-up of human embryonic stem cell production in a stirred microcarrier culture system

2009 ◽  
Vol 42 (6) ◽  
pp. 515-522 ◽  
Author(s):  
A.M. Fernandes ◽  
P.A.N. Marinho ◽  
R.C. Sartore ◽  
B.S. Paulsen ◽  
R.M. Mariante ◽  
...  
Keyword(s):  
Stem Cell ◽  
Embryonic Stem Cell ◽  
Culture System ◽  
Human Embryonic Stem Cell ◽  
Scale Up ◽  
Embryonic Stem ◽  
Microcarrier Culture ◽  
Cell Production

scholarly journals Core–shell hydrogel microcapsules enable formation of human pluripotent stem cell spheroids and their cultivation in a stirred bioreactor

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Pouria Fattahi ◽  
Ali Rahimian ◽  
Michael Q. Slama ◽  
Kihak Gwon ◽  
Alan M. Gonzalez-Suarez ◽  
...  
Keyword(s):  
Stem Cells ◽  
Stem Cell ◽  
Scale Up ◽  
Bioreactor Culture ◽  
Stirred Bioreactor ◽  
Cell Spheroids ◽  
Poly Ethylene ◽  
Aqueous Core ◽  
End Stage ◽  
Stirred Bioreactors

AbstractCellular therapies based on human pluripotent stem cells (hPSCs) offer considerable promise for treating numerous diseases including diabetes and end stage liver failure. Stem cell spheroids may be cultured in stirred bioreactors to scale up cell production to cell numbers relevant for use in humans. Despite significant progress in bioreactor culture of stem cells, areas for improvement remain. In this study, we demonstrate that microfluidic encapsulation of hPSCs and formation of spheroids. A co-axial droplet microfluidic device was used to fabricate 400 μm diameter capsules with a poly(ethylene glycol) hydrogel shell and an aqueous core. Spheroid formation was demonstrated for three hPSC lines to highlight broad utility of this encapsulation technology. In-capsule differentiation of stem cell spheroids into pancreatic β-cells in suspension culture was also demonstrated.

Automated stem cell production by bio-inspired control

2021 ◽  
Vol 33 ◽  
pp. 369-379
Author(s):  
László Monostori ◽  
Balázs Cs. Csáji ◽  
Péter Egri ◽  
Krisztián B. Kis ◽  
József Váncza ◽  
...  
Keyword(s):  
Stem Cell ◽  
Cell Production

scholarly journals Applying Microfluidics for the Production of the Cationic Liposome-Based Vaccine Adjuvant CAF09b

Pharmaceutics ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 1237
Author(s):  
Signe Tandrup Schmidt ◽  
Dennis Christensen ◽  
Yvonne Perrie
Keyword(s):  
Large Scale ◽  
Colloidal Stability ◽  
Scale Up ◽  
Cationic Liposome ◽  
Poly I:C ◽  
Particle Sizes ◽  
Adjuvant Activity ◽  
Lipid Film ◽  
Gmp Production

Subunit vaccines require particulate adjuvants to induce the desired immune responses. Pre-clinical manufacturing methods of adjuvants are often batch dependent, which complicates scale-up for large-scale good manufacturing practice (GMP) production. The cationic liposomal adjuvant CAF09b, composed of dioctadecyldimethylammonium bromide (DDA), monomycoloyl glycerol analogue 1 (MMG) and polyinosinic:polycytidylic acid [poly(I:C)], is currently being clinically evaluated in therapeutic cancer vaccines. Microfluidics is a promising new method for large-scale manufacturing of particle-based medicals, which is scalable from laboratory to GMP production, and a protocol for production of CAF09b by this method was therefore validated. The influence of the manufacture parameters [Ethanol] (20–40% v/v), [Lipid] (DDA and MMG, 6–12 mg/mL) and dimethyl sulfoxide [DMSO] (0–10% v/v) on the resulting particle size, colloidal stability and adsorption of poly(I:C) was evaluated in a design-of-experiments study. [Ethanol] and [DMSO] affected the resulting particle sizes, while [Lipid] and [DMSO] affected the colloidal stability. In all samples, poly(I:C) was encapsulated within the liposomes. At [Ethanol] 30% v/v, most formulations were stable at 21 days of manufacture with particle sizes <100 nm. An in vivo comparison in mice of the immunogenicity to the cervical cancer peptide antigen HPV-16 E7 adjuvanted with CAF09b prepared by lipid film rehydration or microfluidics showed no difference between the formulations, indicating adjuvant activity is intact. Thus, it is possible to prepare suitable formulations of CAF09b by microfluidics.

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