Leapwork’s Post

Click here for the full content: https://bit.ly/CT-785987 #ASGCT 2023 Policy Summit Analysis 2: #CMC information plays a fundamental role in the development and regulation of cell and gene therapies (#CGTs), which has motivated the generation of new policies to facilitate and expedite its evaluation. Celltelligence is publishing a two-part series discussing the strategies the FDA is following to keep up with innovation in the CGT field and providing insights about their relevance in the #celltherapy space. In this second blast, 2 new non-CGT-specific FDA policy initiatives focused on addressing CMC challenges are covered: • The Advanced Manufacturing Technologies (#AMT) designation program • The CMC Development & Readiness [Pilot] Program (#CDRP)

Scaling up a supply chain for cell and gene therapies brings its own unique complexities that product sponsors need to consider. Download the white paper to learn how to scale up logistics and storage capabilities to serve an increasing number of patients, and to accommodate the new stakeholders that join the supply chain post-commercialization. http://ow.ly/EzNP50HyKJl #clinicaltrials #AdvancedTherapies #CellTherapy #GeneTherapy

Embark on a Decade of Breakthroughs with DS InPharmatics! 🚀 Over the past ten years, the approval of cell and gene therapies has paved the way for extraordinary health outcomes for patients. 🌐💊 Curious about the FDA's role in guiding companies through the CMC requirements process for these groundbreaking therapies? 🧬🛠️ Dive into the details and elevate your understanding: https://bit.ly/3Hk9elP Stay informed, stay inspired! Let DS InPharmatics be your guide to the future of healthcare. 💙 #DSIGeneTherapies #HealthcareInnovation #FDAApprovals

Curious about advancing your cell and gene therapies to accelerate patient access? Our experts, Erin Leckrone and Kathleen Kane, share insights into the importance of creating a well-designed and reviewed protocol for clinical trial success. Dive into the insightful Q&A here: https://bit.ly/44Uwdxv #BeTheMatch #CellTherapy #ClinicalTrials

Discover how QPS Holdings, LLC’s Leukopak facility can pave a quicker path to the clinic for cell and gene therapies in this interview with Study Director, Polung Yang! Delve into the recent innovations in the field and how these services can accelerate therapeutic manufacturing >>> https://bit.ly/3V7gW9m

The supply chain for cell and gene therapies is complex and requires next-level precision and oversight. Learn more about what you can do to bridge the gap between manufacturing and delivery of the finished therapy to the patient. https://ow.ly/F8Ki50S90rl

Dive into the exciting world of decentralized supply chains for cell and gene therapies (CGTs) with Jennifer Fenwick and Matthew Lakelin from TrakCel. They've unpacked why digital integration in your supply chain is a game-changer, and how choosing your partners wisely could be the key to success. Plus, discover why there's a shift toward decentralization in clinical trials for CGTs. Intrigued? Access their insightful full Q&A: https://lnkd.in/edqjc7E2

Dive into the exciting world of decentralized supply chains for cell and gene therapies (CGTs) with Jennifer Fenwick and Matthew Lakelin from TrakCel. They've unpacked why digital integration in your supply chain is a game-changer, and how choosing your partners wisely could be the key to success. Plus, discover why there's a shift toward decentralization in clinical trials for CGTs. Intrigued? Access their insightful full Q&A: https://lnkd.in/edqjc7E2

Curious about how distribution models and cold chain management impact product quality for cell and gene therapies? Check out this interview with Azenta’s own David Lewandowski, Director of Business Development for Automated Storage, discussing the hot topic of regulatory challenges for cell and gene therapy manufacturers. It’s part of a collaborative series with Phacilitate and Germfree. #coldchain #CGT #cellandgenetherapies #phacilitate

Very interesting thoughts about the current and future paradigms for cell & gene therapy manufacturing.