World Courier’s Post

How do we meet the scale-up challenge in #cellandgenetherapy? This recent article from Mewburn Ellis discusses how future planning and early-adoption of automated manufacture into cell and gene therapy pipelines can set your company up for long-term success. ➡ https://bit.ly/4bcaK6E 

𝐓𝐡𝐞 𝐧𝐞𝐱𝐭 𝐬𝐭𝐞𝐩 𝐢𝐧 𝐠𝐞𝐧𝐞 𝐭𝐡𝐞𝐫𝐚𝐩𝐲 𝐢𝐬 𝐡𝐞𝐫𝐞.. ➡️ Gene therapy CDMO Ascend Advanced Therapies has acquired another site as they've bought Beacon Therapeutics' Florida site as well as there CMC talent team. Exciting times in the AAV space! Read more below. #biotech #pharma #biopharma #cdmo

If you missed either of our recent webinars, you can now catch them on demand! Our first webinar explores the importance of generating a holistic CMC plan focusing on decision support tools such as Scheduling, Technology Comparisons, Data Trending and Cost of Good Analysis. Mastering CMC Strategies in Cell and Gene Therapy - A Step-by-Step Pathway from Lead to Launch 👉 https://lnkd.in/eZZRpZXW Our second webinar provides a comprehensive overview of the critical elements involved in setting up a robust analytical development process, ensuring project quality, efficacy, and safety. There is a specific example that focuses on the Flow Cytometry technique for analysis of Cell Therapy products. Analytical Development in Cell and Gene Therapy - Setting up for Success 👉  https://lnkd.in/efzJGZNV #itsallaboutmanufacturing #webinar #celltherapy #genetherapy #GMPmanufacturing

“Cell and gene therapies have high development and manufacturing costs. It is the responsibility of all players in the chain to contribute to a cost reduction so these therapies can be accessible to patients,” he said. “Efficient processes are essential for scaling up production to meet growing demand. Additionally, greater production efficiency would help accelerate the path to commercial launch, benefiting developers.” https://lnkd.in/eQwC6_HC

Cell and gene therapies require specialised logistics services that are able to adequately mitigate cold chain risks. Read our latest blog on the challenges of cell and gene logistics and some of the key considerations developers and manufacturers should be aware of. 👇 https://lnkd.in/gDUuc35P #coldchainlogistics #cellandgenetherapy #cellandgenelogistics

🌟 New on Lonrú's Lens: De-risking Cell and Gene Therapy Development 🌍🧬 The cell and gene therapy (CGT) sector is reaching new heights with groundbreaking innovations like CRISPR and record therapy approvals. But with this progress comes significant challenges in regulatory alignment, market access, and manufacturing scalability. In our latest Lonrú Lens blog, we discuss: ✅ How global leaders like the US, UK, Germany, and Japan are adapting their regulatory frameworks. ✅ Opportunities for collaboration across markets to accelerate innovation. ✅ Practical strategies to de-risk development and bring therapies to patients faster. 📖 Dive into the insights here: https://lnkd.in/eJUp3TwG 💡 Data-driven insights in cell and gene therapy. #LonrúLens #CellAndGeneTherapy #Innovation #RegulatoryStrategy #LifeSciences #PrecisionMedicine

👩⚖️ Regulatory innovation is critical to the future of cell and gene therapy. 👩⚖️ The CGT sector continues to break new ground, but challenges in regulatory frameworks and global market access demand fresh, strategic approaches. This piece explores how global regulators are working to overcome these challenges and what it means for companies navigating this space. What’s your take on regulatory collaboration in CGT? Share your thoughts below! 👇 #CellAndGeneTherapy #LonrúConsulting #Innovation #RegulatoryLeadership #CGT #FDA #MHRA #EMA #PMDA

Time is one of the most precious resources we have. It’s especially true in healthcare, where timely access to advanced treatments can make a significant difference in patient outcomes. Whether it’s accelerating the development of new therapies or ensuring patients receive the care they need promptly, every moment counts. Accelerating the time to market for advanced medicines like Cell & Gene Therapies can significantly impact patient outcomes and quality of life. This well written article by Lung-I Cheng, emphasizes the importance of speed in this process to ensure that advanced medicines reach patients as quickly as possible, ultimately improving their chances of receiving timely and effective treatment.

Polymer nanoparticles (PNPs) could be the key to unlocking safer, more effective, and more affordable gene therapies. Battelle’s HIT SCAN™ platform seeks to tackle the final hurdles: precision design, robust manufacturing, and proven reproducibility. With HIT SCAN™, PNP-based therapies are closer than ever to becoming a clinical reality. Read this Inside Battelle blog to learn more https://okt.to/Nr7hkI

Polymer nanoparticles (PNPs) could be the key to unlocking safer, more effective, and more affordable gene therapies. Battelle’s HIT SCAN™ platform seeks to tackle the final hurdles: precision design, robust manufacturing, and proven reproducibility. With HIT SCAN™, PNP-based therapies are closer than ever to becoming a clinical reality. Read this Inside Battelle blog to learn more https://okt.to/8hXGF5