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| Transforming Gene Therapies With Automation, Machine Learning, And AI | Can early and strategic investment in these transformative technologies significantly impact your organization's trajectory? In this on-demand recording, industry experts explore how these technologies are revolutionizing gene therapy development. We dive into strategic planning for selecting the right technologies, ensuring alignment with short- and long-term goals, and scalability. |
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By Annie Lamontagne and Wendy Liang, Dark Horse Consulting Group | The FDA issued the final guidance document Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products on January 29. This article provides a thorough summary of the guidance and where it differs (or not) from the prior version. |
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| Gene Therapies: A Guide To Aseptic Single-Use Connectors | Article | By Amber Sherrick and Derek Pendlebury, CPC | It's important to frequently evaluate your manufacturing process, gauging if improvements can be made. Learn how aseptic connections can impact your efficiency and speed as you continue to scale-up. |
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| ‘Future-proofing’ Cleanroom Facilities | Article | By Dennis Powers, G-CON | Explore factors that can impact the flexibility of your biopharmaceutical facility and cleanrooms as new designs are "future-proofed" to allow for a rapid response to changes in market demands. |
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| Biotech Files NDA Following Risk-Based Mock Inspection | Case Study | inSeption Group | An emerging biotech company collaborates with inSeption Group as a preventive approach to mitigate risks and identify potential concerns prior to an FDA inspection and submitting their NDA. |
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| HIV – Global Clinical Trial Landscape | White Paper | Novotech | Get a comprehensive overview of the global HIV clinical trial landscape since 2018, showcasing regional leadership, trial phases, and growth rates. |
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| Complex Study Delivery: What Is Possible Outside Of A Site? | Webinar | MRN - Medical Research Network | Todd McGrath, chief operating officer, and Emily McDougal, executive director of nurse management, show how the decentralized delivery of complex clinical visits can benefit studies, sites, and patients. |
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| Standardization And Flexibility In Aseptic Filling | Article | Cytiva | Standardization and flexibility in aseptic filling were thought to be mutually exclusive. But what if there was a standardized system with flexibility built into the aseptic process, so you didn’t have to choose? |
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