How to avoid FDA rejection for cell and gene therapies

How can we turbocharge plasmid DNA production to meet the rising demand in gene therapy and DNA vaccines? This case study highlights how process optimization—especially around tangential flow filtration (TFF), can transform pDNA manufacturing. 🔬 With automation and real-time monitoring at the core, the study demonstrates how to maximize recovery and maintain quality at scale. 👉 Read the full article here: https://lnkd.in/eaaKUCK8 #GeneTherapy #DNAVaccines #PlasmidDNA #Biomanufacturing #ProcessOptimization #CGTI #Cellandgenetherapyinsights

Traditional site models can make long-term follow-up in cell and gene therapy trials difficult. Explore how decentralized approaches improve sustainability, compliance, and patient experience. https://bit.ly/43oDMhz #PremierResearch #ClinicalTrials #CGT

Clinigen helped a fast-growing biotech company working on gene therapy for rare diseases by delivering a smart solution for packaging and labelling their product over dry ice ❄️    We also ensured cost-effective storage and global distribution, all while meeting strict ultralow temperature requirements.      👉 Read the case study to see how we made it happen: https://lnkd.in/e-GdTSd4     #clinicalsupply #clinicaltrials #clinicallogistics #packagingandlabelling 

🦠 Lentiviral vectors are central to cell and gene therapy, but scaling production while maintaining yield, purity, and regulatory confidence can be a major hurdle. In this On Demand webinar, you’ll discover practical strategies to streamline LV manufacturing. All within a cGMP-aligned platform designed to support both clinical and commercial LV manufacturing. 🎥 Watch the replay here: https://lnkd.in/e-8QQJaY #LentiviralVectors #CellTherapy #GeneTherapy #Biomanufacturing #cGMP #ViralVectorProduction #CGTI #Cellandgenetherapyinsights

Check out the latest YouTube video covering how to avoid the CMC wall when moving gene therapy from lab to launch 🧬 Get practical insights into navigating scalability, compliance, and regulatory complexity. https://lnkd.in/eJTCPXp8 #GeneTherapy #CMCStrategy #ProductDevelopment #BiotechLaunch #HealthcareCompliance

The FDA has issued two new draft guidance documents aimed at supporting the development and postapproval monitoring of cell and gene therapy (CGT) products: ▪️ Clinical trial design for small populations — innovative approaches, early FDA engagement (comments due Nov. 24) ▪️ Postapproval data collection — real-world data, registries, decentralized methods (comments due Dec. 24). Read the full blog post by Anna Abram and Olive Lee: https://bit.ly/4gJWfea To receive email updates from Eye on FDA, subscribe here: https://bit.ly/45mrnMs #FDA #LifeSciences #HealthPolicy #DrugPolicy

Whether you’re formulating mRNA, siRNA, or exploring next-gen gene therapies, ionizable lipids are key to balancing performance with safety. These pH-sensitive lipids stay neutral in the bloodstream and become active only when and where it counts—like inside the endosome. In our latest blog, we break down what they are, how they work, and what to consider when choosing one for your research or formulation. 📖 Read the full FAQ here: 👉 https://ow.ly/YKiQ50X8JzY #IonizableLipids #LipidNanoparticles #DrugDelivery #mRNADelivery #GeneTherapyTools #FormulationScience #AvantiResearch #PharmaInnovation

Whether you’re formulating mRNA, siRNA, or exploring next-gen gene therapies, ionizable lipids are key to balancing performance with safety. These pH-sensitive lipids stay neutral in the bloodstream and become active only when and where it counts—like inside the endosome. In our latest blog, we break down what they are, how they work, and what to consider when choosing one for your research or formulation. 📖 Read the full FAQ here: 👉 https://ow.ly/Faxx50X2Jmw #IonizableLipids #LipidNanoparticles #DrugDelivery #mRNADelivery #GeneTherapyTools #FormulationScience #AvantiResearch #PharmaInnovation

Whether you’re formulating mRNA, siRNA, or exploring next-gen gene therapies, ionizable lipids are key to balancing performance with safety. These pH-sensitive lipids stay neutral in the bloodstream and become active only when and where it counts—like inside the endosome. In our latest blog, we break down what they are, how they work, and what to consider when choosing one for your research or formulation. 📖 Read the full FAQ here: 👉 https://ow.ly/rsuG50X10g2 #IonizableLipids #LipidNanoparticles #DrugDelivery #mRNADelivery #GeneTherapyTools #FormulationScience #AvantiResearch #PharmaInnovation

Whether you’re formulating mRNA, siRNA, or exploring next-gen gene therapies, ionizable lipids are key to balancing performance with safety. These pH-sensitive lipids stay neutral in the bloodstream and become active only when and where it counts—like inside the endosome. In our latest blog, we break down what they are, how they work, and what to consider when choosing one for your research or formulation. 📖 Read the full FAQ here: 👉 https://ow.ly/mnz150X1gSc #IonizableLipids #LipidNanoparticles #DrugDelivery #mRNADelivery #GeneTherapyTools #FormulationScience #AvantiResearch #PharmaInnovation