Sterility Testing for Hematopoietic Stem Cells

Cundell, Tony; Atkins, James Wade; Lau, Anna F.

doi:10.1128/jcm.01654-22

Cited by 7 publications

(3 citation statements)

References 32 publications

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“…Conversely, allogeneic cells, derived from a distinct donor, demand compliance with more stringent cGMP standards. While a degree of overlap exists between certain aspects of cGTP and cGMP, a worrying trend has been identified ( Cundell, Atkins, and Lau, 2023 ). This trend suggests a deficiency in the implementation of essential aseptic processing controls and robust environmental monitoring programs within routine clinical practice.…”

Section: Discussionmentioning

confidence: 99%

Advances in ex vivo expansion of hematopoietic stem and progenitor cells for clinical applications

Branco,

Rayabaram,

Miranda

et al. 2024

Front. Bioeng. Biotechnol.

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As caretakers of the hematopoietic system, hematopoietic stem cells assure a lifelong supply of differentiated populations that are responsible for critical bodily functions, including oxygen transport, immunological protection and coagulation. Due to the far-reaching influence of the hematopoietic system, hematological disorders typically have a significant impact on the lives of individuals, even becoming fatal. Hematopoietic cell transplantation was the first effective therapeutic avenue to treat such hematological diseases. Since then, key use and manipulation of hematopoietic stem cells for treatments has been aspired to fully take advantage of such an important cell population. Limited knowledge on hematopoietic stem cell behavior has motivated in-depth research into their biology. Efforts were able to uncover their native environment and characteristics during development and adult stages. Several signaling pathways at a cellular level have been mapped, providing insight into their machinery. Important dynamics of hematopoietic stem cell maintenance were begun to be understood with improved comprehension of their metabolism and progressive aging. These advances have provided a solid platform for the development of innovative strategies for the manipulation of hematopoietic stem cells. Specifically, expansion of the hematopoietic stem cell pool has triggered immense interest, gaining momentum. A wide range of approaches have sprouted, leading to a variety of expansion systems, from simpler small molecule-based strategies to complex biomimetic scaffolds. The recent approval of Omisirge, the first expanded hematopoietic stem and progenitor cell product, whose expansion platform is one of the earliest, is predictive of further successes that might arise soon. In order to guarantee the quality of these ex vivo manipulated cells, robust assays that measure cell function or potency need to be developed. Whether targeting hematopoietic engraftment, immunological differentiation potential or malignancy clearance, hematopoietic stem cells and their derivatives need efficient scaling of their therapeutic potency. In this review, we comprehensively view hematopoietic stem cells as therapeutic assets, going from fundamental to translational.

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Section: Discussionmentioning

confidence: 99%

Advances in ex vivo expansion of hematopoietic stem and progenitor cells for clinical applications

Branco,

Rayabaram,

Miranda

et al. 2024

Front. Bioeng. Biotechnol.

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“…GMP for herbal products is a set of guidelines and principles that ensure the quality, safety, and consistency of herbal medicines, supplements, and other herbal products ( Castiglia et al, 2018 ). It involves raw material sourcing and identification, facility and equipment, standard operating procedures, batch records and documentation, quality control testing, validation and qualification, stability testing, recalls and complaints, regulatory compliance, and continuous improvement ( Boyd, 1994 ; Jacquemart et al, 2016 ; Cundell et al, 2023 ). GMP also involve proper documentation, personnel training, hygiene practices, and quality control procedures to ensure consistent quality throughout the manufacturing process ( Castiglia et al, 2018 ).…”

Section: Quality Control For Herbal Medication Productsmentioning

confidence: 99%

“…Processes, equipment, and analytical methods used in herbal product manufacturing should be validated to demonstrate their effectiveness and accuracy ( Williams et al, 2012 ). Herbal products should undergo stability testing to determine their shelf life and storage conditions ( Cundell et al, 2023 ). This helps ensure that the product retains its quality and potency throughout its designated shelf life.…”

Section: Quality Control For Herbal Medication Productsmentioning

confidence: 99%

Advancing herbal medicine: enhancing product quality and safety through robust quality control practices

Wang,

Chen,

Wang

et al. 2023

Front. Pharmacol.

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This manuscript provides an in-depth review of the significance of quality control in herbal medication products, focusing on its role in maintaining efficiency and safety. With a historical foundation in traditional medicine systems, herbal remedies have gained widespread popularity as natural alternatives to conventional treatments. However, the increasing demand for these products necessitates stringent quality control measures to ensure consistency and safety. This comprehensive review explores the importance of quality control methods in monitoring various aspects of herbal product development, manufacturing, and distribution. Emphasizing the need for standardized processes, the manuscript delves into the detection and prevention of contaminants, the authentication of herbal ingredients, and the adherence to regulatory standards. Additionally, it highlights the integration of traditional knowledge and modern scientific approaches in achieving optimal quality control outcomes. By emphasizing the role of quality control in herbal medicine, this manuscript contributes to promoting consumer trust, safeguarding public health, and fostering the responsible use of herbal medication products.

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Challenges and mitigation strategies associated with Burkholderia cepacia complex contamination in pharmaceutical manufacturing

Kumar,

Uthra,

Chitra

et al. 2024

Arch Microbiol

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Sterility Testing for Hematopoietic Stem Cells

Cited by 7 publications

References 32 publications

Advances in ex vivo expansion of hematopoietic stem and progenitor cells for clinical applications

Advances in ex vivo expansion of hematopoietic stem and progenitor cells for clinical applications

Advancing herbal medicine: enhancing product quality and safety through robust quality control practices

Challenges and mitigation strategies associated with Burkholderia cepacia complex contamination in pharmaceutical manufacturing

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