The landscape of the life sciences industry is as vast and varied as the professionals who work in it. Some online resources aim to serve the entire space. We wish them luck. Instead, our goal is to be the most valuable resource for a specific segment of the industry – cell & gene therapies – and the professionals who make their living there. The Cell & Gene community is not made up of generalists. They’re specialists, like us. We deliver in-depth content from authoritative authors and sources because that’s what our community demands.
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A phase-appropriate approach to assay validation is essential for accelerating cell and gene therapy development while ensuring regulatory compliance. This article offers industry recommendations to align methods with critical quality attributes (CQAs), minimizing delays and expediting access to life-changing therapies for patients. #celltherapy #genetherapy #validation
CMC Strategies With CDMOs: Ensuring CQAs For Oligos And Peptides https://lnkd.in/eTD-FgBf - By Kishore Hotha, PhD, MBA, Dr.Hotha's Life Sciences LLC Developing a practical chemistry, manufacturing, and controls (CMC) strategy for advanced molecule therapies demands a shift in approach — focusing on precision, driving innovation, and fostering strong collaborations.?
Leveraging Platform Processes for Developing and Accelerating Novel Gene and Cancer Therapeutics https://lnkd.in/eyDdiDr4 Don’t miss this opportunity to explore the FDA’s new Platform Technology guidance and its impact on accelerating drug approvals. George Buchman PhD of Catalent Pharma Solutions will share expertise on platform processes and supply chain integration, while Dr. Nathalie Clement of Siren Biotechnology highlights groundbreaking cancer therapies combining AAV gene therapy and cytokine immunotherapy. A must-attend for biotech innovators!
UK To Implement Novel Framework For Point-Of-Care Manufacturing https://lnkd.in/ehSB7nF7 - By Jackie Mulryne, Eftychia Sideri, and Heba Jalil, Arnold & Porter The new framework seeks to provide the necessary regulatory oversight to ensure that?point-of-care?and module manufacture products have appropriate quality, safety, and efficacy attributes, while allowing increasing numbers of patients to benefit from these innovative products.
?? Join Us for a Deep Dive into AAV Gene Therapy! Be part of Cell & Gene Live, hosted by Chief Editor Erin Harris, as Dr. Nina Hunter, Vice President of Regulatory and Corporate Strategy at REGENXBIO, shares her insights on the evolving landscape of AAV gene therapy. With her extensive background in regulatory strategy and 12 years at the FDA, Dr. Hunter will discuss regulatory challenges and strategies for bringing innovative AAV therapies to patients. She’ll be joined by Dr. Susan Browne of Passage Bio, where together they’ll address cutting-edge AAV vector design, manufacturing processes, and overcoming immunogenicity challenges. Don’t miss this unique opportunity to learn from two of the field’s leading experts! Register Here: https://lnkd.in/eKkzSM4t
Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's Why https://lnkd.in/eG86EiPB - By Tony Hitchcock, principal and owner, AGH Bioconsulting The cell and gene therapy sector relies heavily on private investment, but funding shortfalls have forced many clinical projects to be delayed or canceled.
TRENDING CONTENT - Catch Up #1. New Economics Of Cell And Gene Therapy – Part II #2. A "Particular" Problem For Cell Therapy Products, Part 2: Cell Clumps And Other Inherent Particles #3. CRISPR And The Commercialization Of Gene-Based Therapies #4. The Advantages Of Raw Material eData Exchange #5. Imbalance In The CDMO Market And The Long-Term Implications #6. Biotech Startup Approaching IND: 5 Mistakes To Avoid While Writing A Development Plan
?? **Unlock the Future of AAV Gene Therapy** Join us at Cell & Gene Live, hosted by Chief Editor Erin Harris, for an exciting discussion with Dr. Sue Browne, Chief Development Officer at Passage Bio. With extensive expertise in drug discovery and development for neurological and rare diseases, Dr. Browne will delve into advancements in AAV vector design, manufacturing, and clinical strategies alongside Nina Hunter, Ph.D., from REGENXBIO. Register Here: https://lnkd.in/etd_T8At Explore the latest insights on overcoming key challenges like immunogenicity and navigating regulatory landscapes in AAV therapies. Don’t miss this opportunity to hear from leaders at the forefront of AAV gene therapy innovation! #AAVGeneTherapy #CellAndGeneLive #Neuroscience #DrugDevelopment
Leveraging Platform Processes for Developing and Accelerating Novel Gene and Cancer Therapeutics https://lnkd.in/eZeACZX2 The FDA’s draft guidance on Platform Technology Designation is a game-changer for drug development. Join us to learn how platform processes are accelerating gene therapy innovation! Catalent Pharma Solutions’ George Buchman PhD and Siren Biotechnology’s Nathalie Clement, Ph.D., will share insights on integrated supply chains, AAV gene therapy, and groundbreaking cancer treatments.
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In her recent article for Cell & Gene, Ocugen's Huma Q., MD, MPH, CMI discusses scaling #genetherapy #clinicaltrials with special attention paid to logistical planning, collaboration with specialized centers, and managing future #manufacturing needs. https://lnkd.in/eSHAYiCp