James Wade Atkins

Sterility Testing for Hematopoietic Stem Cells

Tony Cundell, James Wade Atkins, Anna F. Lau

Over the last two decades, rapid technological advances have led to the wide adoption of cell and gene therapy products for the treatment of a variety of disease states. In this study, we reviewed the literature between 2003 and 2021 to provide …

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Resiliency during a COVID 19 Pandemic: The Quality Manager Perspective

Therese Dodd, James Wade Atkins, Jennifer A. Christian, Karen Collum et autres

Current and Future Cell Therapy Standards and Guidelines

James Wade Atkins, Kamille A. West, Kimberly Anne Kasow

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Improving Quality Manager (QM) Resiliency with Open Communication and Trust between the QM and Program and Organizational Leaders

Christine Rosati, James Wade Atkins, Lisa R. Cantwell, Karen Collum et autres

Background The QM role in the field of transplantation and cellular therapies is specialized. QMs may be at risk for stress and burnout, which results in low resiliency/less ability to recharge during change. Since 2017, the ASBMT Administrative Directors SIG Quality Working …

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Improving Quality Manager (QM) Workload Management in Order to Increase Their Resiliency and Effectiveness in Contributing to Program Success

Therese Dodd, James Wade Atkins, Lisa R. Cantwell, Karen Collum et autres

Background The QM's capacity to be resilient during change is a critical skillset. Since 2017, the ASBMT Administrative Directors SIG Quality Working Group and the FACT Quality Management Committee have collaborated to identify opportunities to increase QMs' resiliency [1]. The quality groups …

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Prospective Evaluation of a Practical Guideline for Managing Positive Sterility Test Results in Cell Therapy Products

Sandhya Ramanathan Panch, Thejaswi Bikkani, Vanessa Vargas, JoLynn Procter et autres

Product safety assurance is crucial for the clinical use of manufactured cellular therapies. A rational approach for delivering products that fail release criteria (because of potentially false-positive sterility results) is important to avoid unwarranted wastage of highly personalized and costly therapies in …

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Immune plasma for the treatment of severe influenza: an open-label, multicentre, phase 2 randomised study

Pablo Tebas, Marie-Carmelle Elie-Turenne, Ednan K. Bajwa, Todd E Bell et autres

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Comparison of automated culture systems with a CFR/USP-compliant method for sterility testing of cell-therapy products

Hanh M. Khuu, Frida Stock, M. McGann, C.S. Carter et autres

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