How can we achieve seamless tech transfer and full process closure in #ATMPmanufacturing while ensuring #GMPcompliance? Our team will share their insights at Cell & Gene Therapy International Europe next week. Their presentation, “Isolator for Aseptic Manufacturing of ATMPs,” will delve into robust strategies, process knowledge, and key controls for advancing aseptic manufacturing practices. 📅 Don’t miss the opportunity to hear from them and explore the future of ATMP manufacturing. Join us there at Cell & Gene Therapy Manufacturing! Where? Convention Center Dublin, Dublin, Ireland When? Dec 2-4, 2024 Bonus? You can also find us at booth #311! #CellAndGeneTherapy #ATMP #AsepticManufacturing #GMP #CGTEU Informa SKAN
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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
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The Innovative Licensing and Access Pathway (ILAP) is a Medicines and Healthcare products Regulatory Agency (MHRA) initiative designed to provide developers of novel medicines with an optimised route to market. ➡️ https://buff.ly/3WKWTQ0 To help therapy developers to leverage the scheme to support successful adoption of their novel therapy, the Cell and Gene Therapy Catapult has created a guide which provides an overview of the ILAP initiative, how it works, and its benefits. Learn more in the link ☝️ #CellTherapy #GeneTherapy #ATMP #AdvancedTherapies #Innovation
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📢 Don't miss tomorrow's Cell & Gene Therapy Insights’ webinar on unlocking success in CAR T tech transfer, featuring expert panelists, Sara Mills at Dark Horse Consulting Group Inc., Neil Blackburn at OmniaBio, and Dan Miskimin at BrainChild Bio. Register today: https://lnkd.in/gJbqp7T9 Key topics: ➡️ Discuss typical obstacles encountered in tech transfer and how to proactively address them. ➡️ Discover how to master the CAR T cell therapy tech transfer process. ➡️ Learn from a real-world case study showing how to achieve seamless transition to GMP manufacturing. #CellandGeneTherapy #CellTherapy #GeneTherapy #Webinar
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Eureka Biotechnology will be at this year’s ASGCT 27th Annual Meeting May 7 - 11, 2024, in Baltimore，MD. Connect with our team of experts throughout this event and learn insights into lentiviral vectors manufacturing. Lentivirus is one of the widely used viral vectors in cell & gene therapy, and the mainstream production system is the four-plasmid transfection system which faces the challenges of high plasmids costs and batch variability at a commercial production scale. To overcome these challenges, Eureka Biotechnology has developed the EuLV Stable System, a suspension-adopted, inducible lentiviral vector production system. The EuLV Stable System features two cutting-edge technology platforms: the Packaging Cell Line System (PCL) and the Stable Producer Cell Line System (SPCL). The PCL system utilizes a single plasmid transient transfection for lentiviral vector production, significantly reducing both plasmid production costs and process complexity. The SPCL system offers a transfection-free platform for lentiviral vector production, thereby eliminating the need for plasmid manufacture and transfection steps. This results in transduction titers that are 10 to 100 times higher compared to traditional methods. The EuLV Stable System streamlines the CMC process and decreases manufacturing costs, presenting a promising solution to alleviate the current bottleneck in lentiviral vector manufacturing. Learn more: https://lnkd.in/gb4GvTpB #ASGCT #Lentiviral Vector #LVV #cell therapy #gene therapy
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Business Development & Consultative Sales Leader | Driving Growth & Innovation in Biologics, Gene Cell Therapy, and Vaccine
Join us tomorrow, December 10th at 11:00 AM EST, for an insightful session on potency assays. Discover how our expertise can support your goals, ensuring robust and reliable results every step of the way. Whether you're navigating complex regulatory requirements or striving for optimal assay performance, we’re here to help! #PotencyAssays #BiotechInnovation #LifeSciences
Don’t forget to register for the Tuesday December 10th webinar to learn how you can overcome the challenges of potency assays in Cell & Gene Therapy! Speakers include: 🎤 Audrey Chang, Ph.D., Executive Director, CMC Advisor 🎤 Joseph Newcome, Senior Director, Analytical Development Together, they'll dive into: ✅ Strategies to tackle the unique challenges of potency assay development. ✅ Case studies and lessons learned from the field. ✅ How to ensure regulatory compliance while maintaining flexibility for innovation. 🗓️ When: December 10th – 08:00 PST / 11:00 EST / 16:00 GMT / 17:00 CET 👉 Register now: https://lnkd.in/ev-E5rm7
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Exciting webinar alert! Discover how 4D Molecular Therapeutics upgraded their maintenance processes with a validated CMMS. Hope to see you there for insightful discussions with industry leaders Dave Porrill and Wes Champion!
Register for a free webinar on "Navigating the New Era of Asset Maintenance Management: A Gene Therapy Company's Transformation". https://lnkd.in/gHFh-dG8 . Attendees will learn how 4D Molecular Therapeutics overhauled their manual maintenance-related processes throughout their facility, unveiling a plethora of improvement opportunities. Dave Porrill from Blue Mountain and Wes Champion from PCI will discuss 4DMT’s journey of implementing a validated Computerized Maintenance Management System (CMMS) and the tangible benefits they reaped. It not only brought about better alignment and structure to their processes, but it also revolutionized their maintenance workflow. Register here to attend: https://lnkd.in/gHFh-dG8 . #BlueMountainRAM #GMPDigitalMaturtityModel #RegulatoryAssetManager #AdvanceGMPcompliance
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🧬 Developing Cell and Gene therapies presents unique quality control challenges, traditional 28-day mycoplasma testing methods which were initially designed for less time-sensitive applications are not suitable any more to meet the urgent demand for expedited therapy delivery to patients. 💡 Discover BIOFIRE® Mycoplasma: a rapid and easy-to-use system with a lab-in-a-pouch technology that helps bring overall efficiencies to the manufacturing process through both simplified workflows and accurate, actionable results to help ensure patient safety. 👉 More on BIOFIRE® Mycoplasma | Pioneering Diagnostics (biomerieux.com)
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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
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Strategic Account Executive at Blue Mountain Quality Resources, RAM, EAM, CMMS, CCMS Cloud for Pharmaceutical, Biotech, Med Device, Capital Equipment and Medical Tech companies.
Hope you can make this webinar as AI continually speeds the process of innovation and it is more crucial then ever to be compliant and audit ready!!!!
Register for a free webinar on "Navigating the New Era of Asset Maintenance Management: A Gene Therapy Company's Transformation". https://lnkd.in/gHFh-dG8 . Attendees will learn how 4D Molecular Therapeutics overhauled their manual maintenance-related processes throughout their facility, unveiling a plethora of improvement opportunities. Dave Porrill from Blue Mountain and Wes Champion from PCI will discuss 4DMT’s journey of implementing a validated Computerized Maintenance Management System (CMMS) and the tangible benefits they reaped. It not only brought about better alignment and structure to their processes, but it also revolutionized their maintenance workflow. Register here to attend: https://lnkd.in/gHFh-dG8 . #BlueMountainRAM #GMPDigitalMaturtityModel #RegulatoryAssetManager #AdvanceGMPcompliance
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🧬 Developing Cell and Gene therapies presents unique quality control challenges, traditional 28-day mycoplasma testing methods which were initially designed for less time-sensitive applications are not suitable any more to meet the urgent demand for expedited therapy delivery to patients. 💡 Discover BIOFIRE® Mycoplasma: a rapid and easy-to-use system with a lab-in-a-pouch technology that helps bring overall efficiencies to the manufacturing process through both simplified workflows and accurate, actionable results to help ensure patient safety. 👉 More on BIOFIRE® Mycoplasma | Pioneering Diagnostics (biomerieux.com)
