The role of biopreservation in cell and gene therapy bioprocessing

Rafiq, Qasim A.; Nienow, Alvin W.; Hewitt, Christopher J.; Coopman, Karen

doi:10.18609/cgti.2017.037

Cited by 5 publications

(4 citation statements)

References 39 publications

(47 reference statements)

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“…Markers: These have become numerous and include the presence of CD105, CD73, CD90, CD102 and CD124 and absence of CD45, CD34, CD14, CD15 and CD18 (for expanded list see [9,31]). Ongoing discussion in the scientific community may yet widen the list of potential surface phenotypic markers for hMSCs [29,30] as the expression of even an ISCT guided set of surface markers has yet to guarantee hMSC homogeneity.…”

Section: "Hmsc Checklist" -A Proposal To Both Enhance Therapeutic Potmentioning

confidence: 99%

The Role of Dissolved Oxygen Levels on Human Mesenchymal Stem Cell Culture Success, Regulatory Compliance, and Therapeutic Potential

Bahsoun

Coopman

Forsyth

et al. 2018

Stem Cells and Development

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Most cells in the human body, including human mesenchymal stem cells (hMSCs), have evolved to survive and function in a low physiological oxygen (O) environment. Investigators have become increasingly aware of the effects of O levels on hMSC biology and culture and are mimicking the natural niche of these cells in vitro to improve cell culture yields. This presents many challenges in relation to hMSC identity and function and in the maintenance of a controlled O environment for cell culture. The aim of this review was to discuss an "hMSC checklist" as a guide to establishing which identity and potency assays to implement when studying hMSCs. The checklist includes markers, differentiation potential, proliferation and growth, attachment and migration, genomic stability, and paracrine activity. Evidence drawn from the current literature demonstrates that low O environments could improve most "hMSC checklist" attributes. However, there are substantial inconsistencies around both the terminology and the equipment used in low O studies. Therefore, "hypoxia" as a term and as a culture condition is discussed. The biology of short-term (acute) versus long-term (chronic) hypoxia is considered, and a nascent hypothesis to explain the behavior of hMSCs in long-term hypoxia is presented. It is hoped that by establishing an ongoing discourse and driving toward a regulatory recognizable "hMSC checklist," we may be better able to provide the patient population with safe and efficacious regenerative treatments.

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Section: "Hmsc Checklist" -A Proposal To Both Enhance Therapeutic Potmentioning

confidence: 99%

The Role of Dissolved Oxygen Levels on Human Mesenchymal Stem Cell Culture Success, Regulatory Compliance, and Therapeutic Potential

Bahsoun

Coopman

Forsyth

et al. 2018

Stem Cells and Development

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“…How about "the manufacture of such [cell and gene] therapies" and "biopreservation of cell and gene therapies"? 8 Medical actions are, as far as I know, not manufactured; and it is not therapies that are biopreserved (whatever that means), but medicines to be used for these therapies. It may become even more confusing when we read about "the freezing of cell therapies" 8 and "cryopreservation of cellular therapies".…”

Section: Introductionmentioning

confidence: 99%

“…8 Medical actions are, as far as I know, not manufactured; and it is not therapies that are biopreserved (whatever that means), but medicines to be used for these therapies. It may become even more confusing when we read about "the freezing of cell therapies" 8 and "cryopreservation of cellular therapies". 9 Such phrases could be understood as (deep-)freezing the therapies, which may be interpreted as stopping or interrupting them, an entirely different meaning than the intended one.…”

Section: Introductionmentioning

confidence: 99%

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Advanced Therapy Medicinal Products: What's in a Name?

Jiskoot

2020

Journal of Pharmaceutical Sciences

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In this commentary I briefly discuss the term advanced therapy medicinal products (ATMPs). The last two words, medicinal products, correctly indicate that we are dealing with medicines. However, oftentimes ATMPs and products within the ATMP family are erroneously called therapies, which may raise confusion, as illustrated with some examples, and may lead to ignorance of the importance of pharmaceutical product quality. The first two words, advanced therapy, are arguable as well, because they do not accurately describe the products involved and advanced is a temporal description of therapies, many of which may not (yet) be advanced at all. It is recommended to avoid such confusing wording and instead call medicines by their proper name.

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