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| Bringing 400+ mRNA experts to Boston this July, the 4th mRNA-Based Therapeutics Summit returns to share exclusive scientific and strategic insights spanning the end-to-end of mRNA drug development. Select your sessions from 4 tracks of content dedicated to Discovery, Translation, Clinical Development or CMC, and join the Next Generation mRNA Delivery Day or Regulatory Affairs Strategy Day to maximize your learnings. See the program |
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By Emily Marden and Kelly Cho, Sidley Austin LLP | This article provides an overview of recent regulatory developments from the U.S. Food and Drug Administration that are pertinent to sponsors pursuing the approval of cell and gene therapies in the United States. |
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Hear from Kathryn Golden, the Senior Vice President of Technical Operations and Cell Manufacturing at bit.bio, as she addresses the importance of potency assays. |
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| Meeting GMP Requirements For Allogeneic Cell Therapies | Webinar | Advanced Instruments, Inc. | Learn why failure to include at least some elements of GMP in your cell line design and development process could make it more difficult to get the data required for future IND or BLAs. |
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| 5 Surprising Findings From OT Vulnerability Assessments | Article | Honeywell Process Solutions | Explore operational technology vulnerability assessment findings that may be unexpected or unanticipated, answers to questions about OT vulnerability assessments and pentesting, and more. |
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| Harvest Of HEK Cells In Extracellular Expression Systems | Application Note | CARR Biosystems | Evaluate the performance of a single-use centrifuge biopharmaceutical organizations can utilize in the clarification of Expi293F cells through its measuring of supernatant turbidity and viable cell recovery. |
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| Genome editing holds immense promise for treating genetic diseases, but off-target effects remain a significant concern. To ensure the safety and efficacy of genome editing therapies, researchers are developing various strategies to reduce off-target effects. Register today for the next Cell & Gene Live. Attendance is free thanks to the support of Bio-Techne. |
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