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| Setting the Standard in Reproducible Performance | Start with a process that delivers high performance and ensure your results can be consistently reproduced. Accelerate your cell and gene therapy development with high-throughput technologies that promote process efficiency, optimized critical raw materials that improve yield, and intuitive data analytics that inform decision-making. Whether you’re in early drug development or approaching large-scale manufacturing, you can rely on our productivity-driven solutions to help you set the standard in reproducible performance. Learn more. |
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By Life Science Connect Editorial Staff | In this episode of Cell & Gene Live, experts examine the current state of AAV quality control and improvement, as well as which advancements the industry could be on the brink of realizing. |
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What is the Office of Therapeutic Products, where did it originate, and what's on its regulatory agenda for 2024? Dr. Nicole Verdun provides information about the new super office, which is the result of a reorganization of CBER’s Office of Tissues and Advanced Therapies. |
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| Breaking Down Barriers In Cell Therapy Manufacturing | Article | Thermo Fisher Scientific Bioproduction | A byproduct of several cell therapy groups attempting to reduce process complexity to make them safer and more cost-efficient is that there's a lack of standardization across the production sector. |
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| Flexible, Global Delivery For Alzheimer’s Patients | Case Study | MRN - Medical Research Network | Uncover how MRN was able to take charge of overseeing clinical trial nurses and participants and work with Washington University to deliver clinical services to over 100 participants worldwide. |
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| Strategic Clinical Consulting Success Stories | Case Study | Veristat, Inc. | Access real-world examples of how the combination of strategic consulting, regulatory insights, and technical expertise can impact the development and approval process. |
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| Disrupting The CGT Manufacturing Industry | Podcast | G-CON | Dennis Powers, VP of Sales Engineering and Business Development, discusses how the off-site manufacturing of modular/podular cleanrooms is affecting therapeutics and industry. |
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| Modernizing TMF Culture To Better Support Today's Clinical Trials | TMF can represent two very different concepts: for some, it's "Trial Master File," while for others, it jokingly stands for "Too Much Fun!" This duality highlights diverse attitudes toward the essential task of preparing and managing the content within the TMF. When structured as a more engaging and less overwhelming task, the TMF can be more beneficial for all who must collaborate to complete it. |
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| Stem cells are the backbone of many allogeneic therapies and where they come from affects development and supply chain logistics, particularly cryopreservation. What temperatures are ideal to maintain product potency? How do you build a reliable cold chain? How do you work with existing infrastructure to allow for an “off-the-shelf” therapy? Don’t miss the next Cell & Gene Live digital event! Registration is free thanks to the support of Charter Medical and Bio-Techne. |
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