Charles River Laboratories’ Post

📢 bioMérieux and NecstGen collaborate to accelerate the development of #CellandGeneTherapies. 🧬 Ensuring the quality, safety, and efficacy of Cell and Gene Therapies (CGT) is crucial. Through our #partnership with NecstGen, CGT researchers and manufacturers gain access to our innovative solutions, enabling effective product and process monitoring. 🧑🔬 Our #Endotoxin Testing Solutions help you achieve GMP compliance and tackle advanced therapy challenges like sample sacrifice, complex compositions, and reducing vein-to-vein time, whilst helping you achieve your #sustainability goals. By breaking down testing bottlenecks, we accelerate CGT development and improve patient access to essential medicines. More information about our solutions: https://lnkd.in/edpxrbge

📢 Master Advanced Therapy: Key Steps for Success! 📝 Understand the advanced therapy process thoroughly. Early insights into manufacturing and analysis are crucial for successful gene and cell therapies. 🧬 Melissa van Pel emphasizes that critical steps must align with GMP guidelines. 🛠️ Engaging early with CDMOs can streamline processes and avoid compliance pitfalls. Remember, balance between detailed testing and timely market entry is key! ⏳ #BioprocessUpdates #AdvancedTherapies #GeneTherapy #CellTherapy #ManufacturingInsights #GMPCompliance #CDMO #BiotechInnovation #HealthcareTrends #TherapeuticDevelopment #MarketEntry #ProcessOptimization #RegulatoryAffairs #LifeSciences #PharmaIndustry #ClinicalResearch ▷ Read the full article here: 📎 https://lnkd.in/dvkVXS67

🚀 At Global Pharma Solutions (GPS), we bring 10 years of expertise in developing cell therapies and navigating interactions with the US FDA. The recently released guidance provides FAQs and highlights common issues in the development of Cellular and Gene Therapy (CGT) products, covering: ✅ Q1-11: Interacting with the FDA (e.g., meeting types and expedited programs) ✅ Q12-20: Product development considerations ✅ Q21-31: Conducting non-clinical studies ✅ Q32-36: Conducting human trials You can refer to the guidance here: https://lnkd.in/eQbNpvJK Contact us today for expert guidance and tailored solutions! 🌟 #CellTherapy #GeneTherapy #FDA #Compliance #GlobalPharmaSolutions #RegulatoryAffairs

With the continued rapid growth of cell and gene therapies, the need for collaboration between sponsors, drug developers, and regulatory agencies becomes more pressing to avoid delays to market. In this panel discussion held during the Alliance for Regenerative Medicine's Cell & Gene Meeting on the Med 2024, experts in advanced therapies discussed the importance of creating a collective global path to CGT approvals. Watch now: https://okt.to/yXV6Sb #celltherapy #genetherapy #ATMPs #advancedmanufacturing #advancedtherapies #cdmo #cellandgenetherapy #biologicstesting #CGMed24

Driving Innovation in Nucleic Acid Delivery! At Avanti Research, we're advancing the future of lipid nanoparticle delivery systems and transfection agents, empowering cell and gene therapies with enhanced precision. Through cutting-edge R&D, new licensing agreements, and strategic growth, we're bringing new Avanti products to market and expanding global manufacturing with support from the UK and US government. With seamless integration of Avanti’s expertise and Croda Pharma with their regulatory and manufacturing know-how, we provide unmatched support from research innovation to GMP excellence. Discover the difference here! https://ow.ly/nPjl30sI37w #AvantiResearch #NucleicAcidDelivery #CellAndGeneTherapy #Innovation

As the demand for cell and gene therapies (CGT) continues to grow, ensuring the success of your plasmid manufacturing is more critical than ever. In our latest blog post, we sat down with Dr. Emma Bjorgum, Vice President of Client Services of the DNA Business Unit at Aldevron, to explore the strategies and best practices for setting up robust CGT programs to meet the challenges of today’s fast-evolving biopharma landscape. 🔬 Optimize plasmid production for high yield and quality 💡 Ensure scalability from research to commercial production ⚙️ Implement best practices for regulatory compliance and process control Read the full blog post now 👉 https://sciex.li/pg10ro #PlasmidManufacturing #CellandGeneTherapy #Biopharma #PlasmidDNA #AAV #GeneTherapy

With the continued rapid growth of cell and gene therapies, the need for collaboration between sponsors, drug developers, and regulatory agencies becomes more pressing to avoid delays to market. In this panel discussion held during the Alliance for Regenerative Medicine's Cell & Gene Meeting on the Med 2024, experts in advanced therapies discussed the importance of creating a collective global path to CGT approvals. Watch now: https://okt.to/Zbp285 #celltherapy #genetherapy #ATMPs #advancedmanufacturing #advancedtherapies #cdmo #cellandgenetherapy #biologicstesting #CGMed24

Driving Innovation in Nucleic Acid Delivery! At Avanti Research, we're advancing the future of lipid nanoparticle delivery systems and transfection agents, empowering cell and gene therapies with enhanced precision. Through cutting-edge R&D, new licensing agreements, and strategic growth, we're bringing new Avanti products to market and expanding global manufacturing with support from the UK and US government. With seamless integration of Avanti’s expertise and Croda Pharma with their regulatory and manufacturing know-how, we provide unmatched support from research innovation to GMP excellence. Discover the difference here! https://ow.ly/LAx230sI3TK #AvantiResearch #NucleicAcidDelivery #CellAndGeneTherapy #Innovation

With the continued rapid growth of cell and gene therapies, the need for collaboration between sponsors, drug developers, and regulatory agencies becomes more pressing to avoid delays to market. In this panel discussion held during the Alliance for Regenerative Medicine's Cell & Gene Meeting on the Med 2024, experts in advanced therapies discussed the importance of creating a collective global path to CGT approvals. Watch now: https://okt.to/IUnBRg #celltherapy #genetherapy #ATMPs #advancedmanufacturing #advancedtherapies #cdmo #cellandgenetherapy #biologicstesting #CGMed24

With the continued rapid growth of cell and gene therapies, the need for collaboration between sponsors, drug developers, and regulatory agencies becomes more pressing to avoid delays to market. In this panel discussion held during the Alliance for Regenerative Medicine's Cell & Gene Meeting on the Med 2024, experts in advanced therapies discussed the importance of creating a collective global path to CGT approvals. Watch now: https://okt.to/19btql #celltherapy #genetherapy #ATMPs #advancedmanufacturing #advancedtherapies #cdmo #cellandgenetherapy #biologicstesting #CGMed24