Kari Airenne’s Post

🧬 New webinar: Navigating Extractables and Leachables (E&L) in Cell and Gene Therapy (CGT) Manufacturing. 🌟 Amidst a dynamic event season, we're excited to announce the 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 Contacts: InfoFarma@eurofins.com   #testingforlife #testing #genetherapy #extractables #leachables #CGT #ATMP #eandl #USP665

🧬 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

Discover how decentralized manufacturing is reshaping the landscape of cell and gene therapy development in this blog capturing insights from our Bridging the Gap webinar series. Gain valuable insights from experts like Dorothea Ledergerber, PhD, Chief Technical Officer at Tigen Pharma, and Patrick Hanley, PhD, Director of the Cellular Therapy Program at Children’s National Hospital. Read the full blog and register for future webinars here: https://hubs.ly/Q02xHWy70 #CellTherapy #GeneTherapy #Innovation #WebinarSeries

Working in gene therapy? About to start working in gene therapy? In Biotech/Pharma, you often move (or are moved) into a new complex area with: 👉 More acronyms than words 👉 Concepts that everyone seems familiar with (but can't explain) 👉 Years of publications or articles to catch up on Then, every now and again, you get an article like the one Cullis and Felgner published in Nature Portfolio's Reviews Drug Delivery, covering Lipid Nanoparticles (LNP), Even as someone who completed a project in LNP in the last year, this article was a great recap, covering plenty of practical topics in an accessible way that would be helpful for anyone regardless of the therapeutic area or product you work on. Cullis, P.R., Felgner, P.L. The 60-year evolution of lipid nanoparticles for nucleic acid delivery. Nat Rev Drug Discov (2024). #personaldevelopment #genetherapy #drugdelivery

As if Stunner was not already the BEST characterization tool - it just got better! Check out this link to watch the recording :) https://lnkd.in/dgq6A3qu

Cell and gene therapy (CAGT) is following a rapid upwards trajectory, but the best methods for post-trial long-term follow-up (LTFU) are still evolving. With the FDA and EMA issuing guidelines for the design and key data elements of required LTFU studies for CAGT, IQVIA Biotech’s Erin Finot, MS, MBA and IQVIA’s Barbara Isquith Arone, MS consider how best to meet them head-on. Read now. https://bit.ly/3zSO25X #biotech #genetherapy #CAGT #celltherapy #clinicaltrials

🔬 We are back with another “Ask a Virologist”! Cell & gene therapy manufacturing is challenging, and a lot of effort goes into establishing a production platform. At Virica we understand the need to enhance CGT productivity without disrupting your current platform. This week, Keara Sutherland, talks about how our Viral Sensitizer (VSEᵀᴹ) can be: ✔ Seamlessly integrated into your production process without disruption. ✔ Rapidly metabolized leaving no residues. 👇 Check out the video to know more! In case you missed the other videos in the series! Our unique mode of action: https://lnkd.in/dusFXNwK What makes VSEs broadly applicable to various virus and cell line combinations and applications: https://lnkd.in/dHxMEGtt Follow along as we highlight the unique aspects of VSEs! 👉 If you find this series valuable subscribe to our newsletter for all things CGT! https://lnkd.in/d-rf3XVX #biomanufacturing #innovation #QandAs #askavirologist

Meet the Sannova team at The American Society of Gene & Cell Therapy (ASGCT) annual meeting, booth # 2048. Conference highlights: ✅Cutting-edge Research ✅Networking Opportunities ✅Professional Development Discover new tools, technologies, and resources essential for advancing your work. Stay up-to-date with industry trends, regulations, and potential future directions in cell and gene therapy. Going to ASGCT2024? Introduce yourself in the comments. #biotech, #immunotherapy, #ASGCT2024 #genetherapy #celltherapy

At the Economist Impact’s Cell and Gene Therapy (CGT) 2024 Summit, experts from across the industry discussed numerous topics and challenges in the introduction of CGTs: 📌 Regulatory 📌 Manufacturing and supply chain 📌 Clinical and scientific 📌 Commercial See the attached white paper capturing important themes and takeaways from the summit, including regulatory changes and new delivery models, the need to keep conversations and practices focused on patients, and how to structure clinical trials, gather real world evidence and streamline manufacturing to help improve access to treatment. #CellAndGeneTherapy #CGT #Innovation #biopharma #EconomistImpact #curiousminds Hannah Kurth

New Trends in Biotechnology Spotlight 25 detailed explanation (3/3) New developments in genome research Lifestyle-related disease market to be entered by siRNA preparations Practical application of gene therapy and the twists and turns of the healthcare system Kanbak of aptamers Changes in drug discovery concepts, binders + effectors DTx companies' setbacks, delays in commercialisation Conditional approval by biomarkers begins Enforcement of inflation control laws wreaks havoc, US healthcare costs Measures to curb Brain Machine Interface clinical trials begin https://lnkd.in/ggrA-3bW