Improved self-renewal and differentiation potentials of mesenchymal Stem Cells by HPL-based xeno free Cell Rev™ mSC ExHQ 2.0

Tan, Zhen; Koh, Hyun‐Moo; Murugan, P.; Talchai, S.; Khemarangsan, V.

doi:10.1016/j.jcyt.2020.03.191

Cited by 1 publication

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“…39 Such animal-derived components are potentially harmful to humans, causing unwanted immunological reactions, leading to prions and transmission of infectious diseases. 40,41 Alternatives need to be chosen and evaluated carefully. The development of xeno-and serum-free MSC culture conditions is ongoing but not yet well established.…”

Section: Culture Medium Formulationmentioning

confidence: 99%

“… 38 Recently, the Food and Drug Administration found that over 80% of the 66 Investigational New Drug submissions for clinical MSC products (as of 2012) still used FBS during the manufacturing process 39 . Such animal‐derived components are potentially harmful to humans, causing unwanted immunological reactions, leading to prions and transmission of infectious diseases 40,41 . Alternatives need to be chosen and evaluated carefully.…”

Section: Current Development Of Gmp‐compliant Msc and Exosome Manufac...mentioning

confidence: 99%

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Translating mesenchymal stem cell and their exosome research into GMP compliant advanced therapy products: Promises, problems and prospects

Ma,

Zhai,

et al. 2023

Medicinal Research Reviews

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Mesenchymal stem cells (MSCs) are one of the few stem cell types used in clinical practice as therapeutic agents for immunomodulation and ischemic tissue repair, due to their unique paracrine capacity, multiple differentiation potential, active components in exosomes, and effective mitochondria donation. At present, MSCs derived from tissues such as bone marrow and umbilical cord are widely applied in preclinical and clinical studies. Nevertheless, there remain challenges to the maintenance of consistently good quality MSCs derived from different donors or tissues, directly impacting their application as advanced therapy products. In this review, we discuss the promises, problems, and prospects associated with translation of MSC research into a pharmaceutical product. We review the hurdles encountered in translation of MSCs and MSC–exosomes from the research bench to an advanced therapy product compliant with good manufacturing practice (GMP). These difficulties include how to set up GMP‐compliant protocols, what factors affect raw material selection, cell expansion to product formulation, establishment of quality control (QC) parameters, and quality assurance to comply with GMP standards. To avoid human error and reduce the risk of contamination, an automatic, closed system that allows real‐time monitoring of QC should be considered. We also highlight potential advantages of pluripotent stem cells as an alternative source for MSC and exosomes generation and manufacture.

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Section: Culture Medium Formulationmentioning

confidence: 99%

Section: Current Development Of Gmp‐compliant Msc and Exosome Manufac...mentioning

confidence: 99%

Translating mesenchymal stem cell and their exosome research into GMP compliant advanced therapy products: Promises, problems and prospects

Ma,

Zhai,

et al. 2023

Medicinal Research Reviews

View full text Add to dashboard Cite

show abstract

Improved self-renewal and differentiation potentials of mesenchymal Stem Cells by HPL-based xeno free Cell Rev™ mSC ExHQ 2.0

Cited by 1 publication

References 0 publications

Translating mesenchymal stem cell and their exosome research into GMP compliant advanced therapy products: Promises, problems and prospects

Translating mesenchymal stem cell and their exosome research into GMP compliant advanced therapy products: Promises, problems and prospects

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