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Social Pharma Patient-Centric Marketing socialpharma.net >>> Gene&Cell Therapy >> Regenxbio touts positive mid-stage data for AbbVie-partnered vision loss gene therapy, but no detailed plans for pivotal study #lucidquest #genetherapy #celltherapy

Watch our on-demand webinar on overcoming upstream and downstream process barriers for large-scale AAV production! Watch our esteemed speakers from Encoded Therapeutics and Thermo Fisher Scientific share their valuable insights and strategies to optimize your AAV manufacturing process, ultimately accelerating the development of safe and effective gene therapies. Key Takeaways: ✅ Discover an end-to-end solution for the development and commercial production of AAV. ✅ Learn about new products and technologies that can enhance production efficiency, address regulatory concerns, and facilitate the scale-up of AAV production protocols. ✅ Gain a comprehensive understanding of how gene therapy developers are currently tackling critical manufacturing challenges.

Cell and Gene Therapy in 2040. Have you read the PA Consulting report compiled by Simon Burnell, Paolo Siciliano and team? It's a fascinating read highlighting four alternative views of C&GT in 2024. Link here > https://lnkd.in/eRyw2bpR We know which version of this world we want to live in. CellRev believe that access is in the process. There is an extremely healthy pipeline of treatments progressing through clinical trials, however, manufacturing remains inherently inefficient. We focus our efforts on transforming manufacturing efficiency to create a world where ground-breaking treatments are readily available and no longer cost prohibitive. In this world, C&GTs are first-line treatments; not last. Reach out to us at enquiry@cellrev.co.uk to discover how we can develop or optimise your cell culture process with our proprietary solutions.

This draft guidance provides recommendations for developing a science- and risk-based strategy to help assure the potency of a human cellular therapy or gene therapy (CGT) product.

Baby steps for global harmonization of quality dossiers at least for small molecules are a huge step. Maybe this will soon be a reality for well-known biological products as well, although Cell and Gene Therapy product will need to wait a bit longer. This article summarized some interesting reflections on this topic from FDA’s principal deputy commissioner Janet Woodcock. #fda #ema #parexelwithheart

I learned a lot today during the first day of the CASSS – Sharing Science Solutions Cell and Gene Therapy Products Symposium 2024! There were several insightful talks addressing the evolution of analytical methods used in process development to meet regulatory expectations. As expected, the development of #potency methods and control strategies for #AAV was a significant topic. Also, the FDA's Nicole Verdun gave an excellent overview of the agency's current approach to regulating #CGTs. She covered topics like the use of accelerated approval for gene therapies given the possibility of using #biomarkers as endpoints to predict clinical benefits, and common #CMC pitfalls such as scaling manufacturing, potency assays, and #comparability studies. #genetherapy #innovation #technology #cgtp2024 #cgtp

Watch our on-demand webinar on overcoming upstream and downstream process barriers for large-scale AAV production! Watch our esteemed speakers from Encoded Therapeutics and Thermo Fisher Scientific share their valuable insights and strategies to optimize your AAV manufacturing process, ultimately accelerating the development of safe and effective gene therapies. Key Takeaways: ✅ Discover an end-to-end solution for the development and commercial production of AAV. ✅ Learn about new products and technologies that can enhance production efficiency, address regulatory concerns, and facilitate the scale-up of AAV production protocols. ✅ Gain a comprehensive understanding of how gene therapy developers are currently tackling critical manufacturing challenges.

Read PSC Biotech Corporation's latest white paper. Connect with us to learn about how we can help with validation - www.biotech.com/contact-us. #pscbiotech #biotech #cellandgenetherapy #celltherapy #genetherapy #validation #validationengineer

🧬 New webinar: Navigating Extractables and Leachables (E&L) in Cell and Gene Therapy (CGT) Manufacturing. 🌟 Join our latest webinar taking place on June 12, 2024, 3.00 PM - 4.00 PM CEST. 🧬💉Cell and Gene Therapies (CGTs) are shaping the future of medicine offering groundbreaking treatments. CGTs are primarily manufactured via single-use systems (SUS) which consist of many different components. Manufacturers need to face unique challenges of evaluating the extractables and process equipment-related leachables. 💻 This webinar will delve into the challenges faced by manufacturers in developing a successful E&L testing strategy, offering practical advice on study design and result interpretation. 🎧 Our expert speakers Stefano Baila and Daniele Zarini will provide insights into handling E&L studies for components that are specifically utilised in CGTs, in order to meet regulatory requirements and expectations, and ultimately ensure product quality and patient safety. 🎯 The risk of extractables and leachables in cell therapy manufacturing and how the new USP<665> and <1665> chapters could be adapted to CGTs will be specifically addressed. Learn more and register here: https://lnkd.in/d2WqUEAH #testingforlife #testing #genetherapy #extractables #leachables #CGT #ATMP #eandl #USP665

A robust chemistry, manufacturing and control (CMC) implementation is crucial in cell and gene therapies (#CGTs) to ensure regulatory compliance in the whole product development life cycle. In this blog, the last in our series exploring CGTs, we delve into various strategies aimed at facilitating regulatory compliance, while also emphasising the importance of maintaining consistency and traceability across the entire lifecycle.