Biocom California recently invited Sapient to contribute an article for its Lifelines Magazine edition focused on innovations in #genetherapy and #celltherapy. https://bit.ly/3KbQEOm While cell- and gene-based treatments are advancing rapidly, spurred by a landmark year of FDA approvals, their development is not without challenges. We discuss how #multiomics for gene and cell therapy can deliver the novel insights needed to realize the incredible therapeutic potential represented in these pipelines today: https://bit.ly/3KbQEOm
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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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Don't miss Miloš Miljković, M.D. who will be joining our panel discussion on Cell & Gene Therapy Manufacturing: A Look at Supply Chains, Treatment Centers, and Patient Slots at the Cell and Gene Virtual Event on November 20. https://ow.ly/yP6y50TKZAY Since the introduction of CAR-T cell therapies like Novartis' Kymriah, production challenges have been a key focus for developers. In this session, we’ll explore the innovations in manufacturing that are addressing these challenges, from supply chain issues to capacity management, ensuring patients receive the treatments they need. Get ready for an in-depth discussion on the latest manufacturing advancements and how they're shaping the future of cell and gene therapies! Register now: https://ow.ly/yP6y50TKZAY #CellandGene #Biotech #Manufacturing #CAR-T #SupplyChain #FierceCellAndGene #HealthcareInnovation
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As I connect with CMC Regulatory professionals over the phone daily, I frequently hear their interest in gaining experience in—or, for those in leadership roles, contributing expertise to—businesses focused on cell and gene therapy. Sharing an insightful read below: “As of today, there are 2,041 potential gene-based therapies in various stages of clinical development, underscoring the vast potential of this field. The future of healthcare is being reshaped by these innovations, bringing hope to patients worldwide.” #CellTherapy #GeneTherapy #RegulatoryAffairs #Biopharma #CMC #Innovation #GeneTherapies #Genomicmedicine 📖 ---> https://lnkd.in/gcDGPDMq
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Don’t forget to attend our sponsored session at the American Society of Gene & Cell Therapy (ASGCT) 27th Annual Meeting on Friday, May 10 from 8-8:30 a.m. EDT. This session will cover how strategic collaborations between #CDMOs and #CROs are addressing industry challenges related to #viralvector production, leading to: - Improved AAV production titer with a significant reduction in cost of goods via high-throughput processes and analytical development - Direct scale-up from bench to 2,000L - Strategies for enhancing % full enrichment during downstream processing - Developing customer-centric analytics for viral vector characterization in development and GMP settings Learn more about this sponsored session here: http://spr.ly/6047jdT23
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“As the advanced therapy sector approaches a critical juncture in its growth, the industry’s ability to navigate these challenges will define its trajectory and potential to revolutionize treatment paradigms.” – Deloitte’s 2024 Advanced Therapy Industry Report Examining the current landscape of cell and gene therapy, with input from 376 respondents across the ecosystem, Deloitte's report identifies both challenges and opportunities across research, development, manufacturing, commercialization and patient access. Key insights from the report include: ⚙️Over 40% of industry leaders are unsure about meeting the future demand for advanced therapies ⚙️Nearly 90% of therapy developers are now collaborating with external manufacturers to accelerate the path to market ⚙️Payer and reimbursement issues remain a top concern for the commercialization of advanced therapies We’ve summarized the key takeaways ⬇️ Download the full report: https://lnkd.in/eDFPAutA #ManufacturingBrighterFutures #CellTherapy #GeneTherapy #PatientAccess #Biotechnology
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Hope to see you there! My colleagues Pouria Motevalian and Amy Lavelle will be presenting on these hot topics - scaling up gene therapy processes & analytical strategy #asgct2024
Are you going to the American Society of Gene & Cell Therapy (#ASGCT) 27th Annual Meeting in #Baltimore, Maryland from May 7-11? If so, be sure to attend Thermo Fisher Scientific's sponsored session on Friday, May 10 at 8 a.m. EDT: “Revolutionizing #genetherapy services: A synergistic approach to analytics and scaling up through CDMO-CRO collaboration.” This session will explore the possibilities of adeno-associated viral (#AAV) vectors as widely-used carriers for #genetherapy medicinal products (#GTMPs). It will also discuss the challenges in #scalability and #analytics during AAV production that may limit their impact. Additionally, it will cover how strategic CDMO-CRO collaborations can help address these hurdles. Learn more about this sponsored session here: http://spr.ly/6044brBXa
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Are you going to the American Society of Gene & Cell Therapy (#ASGCT) 27th Annual Meeting in #Baltimore, Maryland from May 7-11? If so, be sure to attend Thermo Fisher Scientific's sponsored session on Friday, May 10 at 8 a.m. EDT: “Revolutionizing #genetherapy services: A synergistic approach to analytics and scaling up through CDMO-CRO collaboration.” This session will explore the possibilities of adeno-associated viral (#AAV) vectors as widely-used carriers for #genetherapy medicinal products (#GTMPs). It will also discuss the challenges in #scalability and #analytics during AAV production that may limit their impact. Additionally, it will cover how strategic CDMO-CRO collaborations can help address these hurdles. Learn more about this sponsored session here: http://spr.ly/6044brBXa
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To close the week, we would like to remind you of the final slide deck/presentation created by experts within BioPhorum Advanced Therapy Medicinal Products on validation challenges and method validation controls. You can download the slide deck/presentation here: https://lnkd.in/e6HKtXT8 This method validation controls content reviews the regulatory challenges faced in cell and gene therapy with a focus on identifying and using appropriate analytical controls when dealing with both limited regulatory guidance and limited materials - thus providing possible options to avoid potential issues and accelerate the validation process. The content focuses on challenges such as appropriate controls and standards, alternative materials when resources are scarce, and the relevance of reference standards when processes change. To view BioPhorum Advanced Therapy Medicinal Products’ full portfolio of publications visit: https://lnkd.in/exqf9Khu #ATMP #celltherapy #genetherapy #validation
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What does the future hold for cell therapy? In Cell & Gene's Executive Roundtable, executives from FibroBiologics (Nasdaq: FBLG), Ossium Health, and Triumvira Immunologics, Inc. joined Tyler Menichiello of Bioprocess Online to share predictions for 2025 and beyond. Discussions covered manufacturing advancements, AI adoption, regulatory hurdles, and strategies for navigating a challenging funding landscape. Watch here and learn where the industry is headed: https://bit.ly/3PtfFXI #CellTherapy #Innovation #FutureofMedicine
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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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