ISCT, International Society for Cell & Gene Therapy’s Post

Hoping to see you soon at our upcoming webinar!

It can take 10+ years to develop a safe and effective #cellandgenetherapy for patients, a process often complicated by the challenges associated with progressing innovative R&D processes to standardized and robust manufacturing methods. Thermo Fisher Scientific has responded to this industry challenge by developing our Rapid Development Framework™, which can streamline the complexity of #regenerativemedicine and #immunotherapy workflows for cell and gene therapies. Our upcoming webinar in partnership with #PharmaIgnite will take a deep dive into this framework, exploring how it can expedite #drugdevelopment and manufacturing timelines while staying adaptable to the unique needs of each product. Register here: http://spr.ly/6044g0Qj4

Don't miss the new Drug Discovery World newsletter, with all the latest in cancer research and gene therapy news, as well as analysis of the RNA landscape and AI's role in drug repurposing. https://lnkd.in/e3Q6ZNUa #drugdiscovery #drugdevelopment #pharma #biotech #newsletter

Potency assays can be challenging for advanced biologics including viral vector-based therapies. In this whitepaper, learn about Catalent’s mRNA transcriptional assay and how it compares to other analytical methods used to assess potency for cell and gene therapies. #analytical #ATMP #potencyassay #analytical #ATMP https://ow.ly/eKz150TuLNv

12 Days of Cell Therapy 🎄 On the final days of our countdown, we look ahead to the exciting opportunities the Cell and Gene Therapy sector holds as we close out 2024. Day 11: As the year draws to a close, we’ve witnessed ten regulatory approvals to date, including CASGEVY®, AMTAGVI, LENMELDY, BEQVEZ™, TECELRA, Upstaza™, AUCATZYL®, REGENECYTE™, SYMVESS™ and most recently, Ryoncil®. With additional therapies awaiting regulatory clearance, additional approvals could occur before year end. This promising wave of approvals highlights the growing confidence in the field, marking a key moment in the expansion of life-changing therapies for patients. With more therapies making their way through the regulatory process, the potential for transformative healthcare solutions continues to grow. Source: https://lnkd.in/e_SRS38z

𝐔𝐂𝐒𝐅, 𝐀𝐧𝐧𝐨𝐠𝐞𝐧 𝐀𝐧𝐧𝐨𝐮𝐧𝐜𝐞 𝐂𝐨𝐥𝐥𝐚𝐛𝐨𝐫𝐚𝐭𝐢𝐨𝐧 𝐭𝐨 𝐈𝐝𝐞𝐧𝐭𝐢𝐟𝐲 𝐒𝐮𝐩𝐞𝐫𝐢𝐨𝐫 𝐓𝐫𝐞𝐠-𝐒𝐩𝐞𝐜𝐢𝐟𝐢𝐜 𝐏𝐫𝐨𝐦𝐨𝐭𝐞𝐫𝐬 Annogen and the prestigious labs of Qizhi Tang and Brian Shy at University of California, San Francisco today announced a collaboration to identify and characterize promoters specific for regulatory T cells (Tregs). This partnership aims to set a new benchmark for precision gene expression in Treg cell therapies. Read the full article: https://lnkd.in/dUXqTvqi #celltherapy #geneediting #crispr #immunotherapy #genetherapy

📆Day one at the 𝟑𝐫𝐝 𝐂𝐞𝐥𝐥 𝐓𝐡𝐞𝐫𝐚𝐩𝐲 𝐏𝐨𝐭𝐞𝐧𝐜𝐲 𝐀𝐬𝐬𝐚𝐲 𝐒𝐮𝐦𝐦𝐢𝐭 in Boston and the Cellply team, Massimo Bocchi and Marco Fadda, are joining the many discussions about the challenges of potency assay development for these therapeutics. They are joining the many analytical, QC, and regulatory experts who are sharing insights into the real-world issue and assessing the impact of the FDA’s draft guidance “Potency assurance for cellular and gene therapy products”.   With VivaCyte now available commercially, there is a 𝐧𝐞𝐰 𝐩𝐫𝐚𝐜𝐭𝐢𝐜𝐚𝐥 𝐨𝐩𝐭𝐢𝐨𝐧 𝐟𝐨𝐫 𝐝𝐞𝐞𝐩 𝐜𝐡𝐚𝐫𝐚𝐜𝐭𝐞𝐫𝐢𝐳𝐚𝐭𝐢𝐨𝐧 𝐨𝐟 𝐭𝐡𝐞𝐬𝐞 𝐜𝐞𝐥𝐥𝐮𝐥𝐚𝐫 𝐭𝐡𝐞𝐫𝐚𝐩𝐢𝐞𝐬 that offers novel insights to enhance understanding of these vital cell therapy products. 📍𝐁𝐎𝐎𝐓𝐇 #𝟒 #CellCharacterization #PotencyAssay #CellTherapy

Check out the regulatory milestones in the CGT drug development process!👇 The journey of translating CRISPR therapies from the bench to clinical trials is not driven solely by technical advancements, but also by a concerted effort that requires both consideration of established regulatory guidance as well as ongoing dialogue with regulatory bodies. Download whitepaper here https://bit.ly/46F710k and we will guide you through the intricate regulatory journey of cell and gene therapies (CGTs), helping you optimize your pathway to success. #drugdevelopment #CRISPR #clinicaltrial #whitepaperdownload #CGT

Potency assays can be challenging for advanced biologics including viral vector-based therapies. In this whitepaper, learn about Catalent’s mRNA transcriptional assay and how it compares to other analytical methods used to assess potency for cell and gene therapies. #potencyassay #analytical #ATMP #potencyassay #analytical #ATMP https://ow.ly/eKz150TuLNv

As a leader in the commercialization of cell and gene therapies, we continue to invest so we can support patients with diseases for which there are little or no treatment options. Watch the video below to learn more about our Advanced Therapy Innovation Center and the work being done to move this area of medicine forward. #cellandgene