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| Webinar: Evolving Gene Editing for Rare Disease Drug Development | Danaher is partnering with leading academic and clinical research institutes focused on the development of a novel platform approach to gene editing aimed at accelerating the delivery of therapies and creating economies of scale to treat ultra-orphan conditions. We will explore how to create scalable models for efficient manufacturing and broader patient access and formulate regulatory and clinical strategies to address rare disease challenges. Learn more. |
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FOCUS ON REGULATORY & COMPLIANCE |
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This is Episode 1 of a special series of Cell & Gene: The Podcast, "FDA Fridays." This first episode features Host Erin Harris' conversation with Kaye Spratt, Strategic and Non-Clinical Regulatory Consultant at Spratt Advanced Cell & Gene Therapy Regulatory Consulting. |
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| Understanding Potency In Gene Therapy Development | White Paper | By Chelsea Pratt, Ph.D., Bio-Rad Laboratories, Inc. | Explore the current state of the cell and gene therapy industry with a focus on the challenges associated with measuring potency throughout the manufacturing process. |
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| Risks And Safety Measures For Cytotoxic Compounding | Article | Ecolab Life Sciences | Cytotoxic compounding poses risks like contamination and exposure, causing serious health effects. Safety measures include isolators, PPE, SOPs, and advanced technologies like the Bioquell Qube. |
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REGULATORY & COMPLIANCE SOLUTIONS |
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| Advancing the Future of Cell & Gene Therapy | This 11-12 November, Cell 2025 unites 1,000+ leading experts across the CGT value chain to solve key challenges, from scalable bioprocessing and regulatory hurdles to accelerating development timelines. Gain practical strategies across cell culture, therapy development, and CGT manufacturing, and hear from world-renowned leaders Bobby Gaspar (CEO, Orchard Therapeutics), Christof Von Kalle, (Director & BIH Chair, Research Clinic Luxemburg), and Dame Molly Stevens (University of Oxford). Register Now |
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